COMMITMENTS AND CONTINGENCIES	6 Months Ended
Jun. 30, 2026
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	COMMITMENTS AND CONTINGENCIES Operating Leases The majority of the Company’s leases as of June 30, 2026 are classified as operating leases. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company’s lease agreements do not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. Rent expense is recognized on a straight-line basis over the lease term. Operating lease ROU assets are included in other non-current assets and operating lease liabilities are included in accrued expenses and other and other non-current liabilities in the unaudited condensed consolidated balance sheets. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. Government Regulation The Company’s products and facilities are subject to regulation by a number of federal and state governmental agencies, such as the Drug Enforcement Administration (“DEA”), the FDA, the Centers for Medicare and Medicaid Services, the Central Drugs Standard Control Organization, the Narcotics Control Bureau (“NCB”), and India’s Ministry of Health and Family Welfare. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of ANI’s products. The DEA and NCB maintain oversight over products that are considered controlled substances. Unapproved Products Four products, Esterified Estrogen with Methyltestosterone (“EEMT”), Opium Tincture, Thyroid Tablets, and Hyoscyamine, are marketed without approved NDAs or ANDAs. During the three and six months ended June 30, 2026, net revenues from commercial sales of these products totaled $5.7 million and $11.9 million, respectively. During the three and six months ended June 30, 2025, net revenues from commercial sales of these products totaled $6.1 million and $11.6 million, respectively. Legal Proceedings The Company is involved, and from time to time may become involved, in various disputes, governmental and/or regulatory inquiries, investigations, government reimbursement related actions and litigation. These matters are complex and subject to significant uncertainties. While the Company believes that it has valid claims and/or defenses in the litigation and other matters described below, litigation is inherently unpredictable, particularly where the damages sought are substantial or indeterminate or when the proceedings, investigations or inquiries are in the early stages, and the outcome of the proceedings could result in losses, including substantial damages, fines, civil or criminal penalties and injunctive or administrative remedies. The Company intends to vigorously prosecute and/or defend these matters, as appropriate; however, from time to time, the Company may settle or otherwise resolve these matters on terms and conditions that it believes are in the Company’s best interests. Resolution of any or all claims, investigations, and legal proceedings, individually or in the aggregate, could have a material adverse effect on the results of operations and/or cash flows in any given accounting period or on the Company’s overall financial condition. Unless otherwise disclosed, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. The Company records accruals for loss contingencies to the extent it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. From time to time, the Company may also be involved in other pending proceedings for which, in the opinion of management and based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to its results, and therefore remain undisclosed. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of management, become material, the Company will disclose such matters. Furthermore, like many pharmaceutical manufacturers, the Company is periodically exposed to product liability claims. The prevalence of these claims could limit the Company’s coverage under future insurance policies or cause those policies to become more expensive, which could harm its business, financial condition, and operating results. Recent trends in the product liability and director and officer insurance markets are to exclude matters related to certain classes of drugs. The Company’s policies have been subject to such exclusions which place further potential risk of financial loss on the Company. Legal fees for litigation-related matters are expensed as incurred and included in the consolidated statements of operations under the selling, general, and administrative expense line item. Commercial Litigation On March 4, 2024, ANI commenced a civil action against CG Oncology, Inc. f/k/a Cold Genesys, Inc. (“CG Oncology”) in the Superior Court of the State of Delaware (“Delaware Action”). ANI’s complaint alleges that, under an Assignment and Technology Transfer Agreement dated as of November 15, 2010 (the “November 2010 Agreement”), CG Oncology is liable to pay ANI a running royalty of 5% of the worldwide net sales of cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. On April 2, 2024, CG Oncology filed an answer and counterclaim (the “CGON Answer and Counterclaim”) and concurrently moved for judgment on the pleadings or, in the alternative, for partial summary judgment (the “Motion for Summary Judgment”). CG Oncology’s Motion for Summary Judgment sought judgment declaring that the November 2010 Agreement does not “oblige CGON to pay royalties after expiration of the latest-running assigned patent.” On April 25, 2024, ANI filed a reply to CG Oncology’s counterclaims, denying any liability to CG Oncology and asserting additional counterclaims against CG Oncology (“Reply Counterclaims”) for alleged breach of the November 2010 Agreement and, in the alternative, for unjust enrichment. On May 15, 2024, CG Oncology filed a reply to ANI’s counterclaims, denying any liability to ANI and generally maintaining the positions taken in the CGON Answer and Counterclaim. On November 18, 2024, the court denied CG Oncology’s Motion for Summary Judgment. On June 2, 2025, CG Oncology filed five motions for summary judgment seeking dismissal of all of ANI’s claims and counterclaims, including breach of the royalty payment provision, breach of good faith performance, breach of the implied covenant of good faith, and in the alternative, unjust enrichment. Also on June 2, 2025, ANI filed a motion for partial summary judgment seeking dismissal of CG Oncology’s counterclaims for unenforceability of the royalty payment provision under Brulotte, breach of good faith performance, breach of confidentiality and trade secret misappropriation. At a pretrial conference on July 16, 2025, the court granted CG Oncology’s motion for partial summary judgment on its Brulotte counterclaim and affirmative defense, but allowed the case to proceed on ANI’s counterclaim for unjust enrichment. The court also granted ANI’s motion for partial summary judgment, dismissing CG Oncology’s breach of confidentiality and trade secret misappropriation claims. The jury trial commenced in Delaware Superior Court on July 21, 2025. On July 29, 2025, a verdict was returned by the jury, finding that (1) the unenforceability of the royalty payment provision in the November 2010 Agreement did not affect the economic or legal substance of the transactions contemplated thereby in a manner that was materially adverse to ANI, and (2) awarding no damages to ANI on its unjust enrichment counterclaim. On August 12, 2025, ANI filed a motion for a new trial and for judgment as a matter of law. A hearing on the motions was held by the court on April 10, 2026. On July 16, 2026, the court denied ANI's motions. ANI intends to appeal these decisions to the Delaware Supreme Court. On March 6, 2024, a complaint was filed against ANI by Acella Pharmaceuticals, LLC, in the United States District Court of Minnesota, asserting, among other things, false advertising under the Lanham Act, and unfair trade practices and false advertising under Minnesota law, relating to ANI’s natural desiccated thyroid tablets USP. The complaint seeks injunctive relief, actual and consequential damages, disgorgement of profits, and attorneys’ fees and costs. On June 7, 2024, ANI filed an amended answer to Acella’s complaint, denying all claims, and asserting certain affirmative defenses, and counterclaims against Acella for false advertising of its thyroid product marketed as NP Thyroid® Tablets, under the Lanham Act, and for deceptive trade practices under Minnesota and Georgia law. ANI seeks injunctive relief, compensatory damages, punitive damages and attorneys’ fees and costs. On April 15, 2026, ANI and Acella filed cross motions for summary judgment against each other’s respective claims. The parties have been unable to reach a settlement to date. Fact and expert discovery are now closed. A hearing is set for August 25, 2026 on the parties’ summary judgment motions. A trial date has not been set. ANI disputes any liability in this matter and continues to defend this lawsuit vigorously. Patent Infringement Litigation Harmony Biosciences Patent Litigation On April 20, 2026, Harmony Biosciences Management, Inc. (“Harmony Management”), along with Novitium, as exclusive licensor of certain intellectual property to Harmony Management, including U.S. Patent No. 11,623,920 (the “920 Patent”), filed a lawsuit against AET Pharma US, Inc., AET Laboratories Private Limited, Alfred E. Tiefenbacher (GmbH & Co. KG) (collectively, “AET”), Sandoz Inc., Sandoz Private Limited, and Sandoz GmbH, alleging that the defendants’ actions in connection with the filing of AET’s ANDA No. 218892 infringe one or more claims of the 920 Patent. The case was filed in the United States District Court for the District of Delaware and assigned case no. 26-cv-00453-JLH. On June 22, 2026, the defendants filed an answer to the complaint, along with counterclaims alleging various antitrust counterclaims against Harmony Management individually and against Harmony Management and Novitium jointly. On July 6, 2026, the parties stipulated that defendants Sandoz Private Limited and Sandoz GmbH be dismissed without prejudice, which stipulation was granted on July 7, 2026. On July 21, 2026, the defendants filed an amended answer updating the complaint to remove those parties. Novitium intends to continue to pursue this matter and to vigorously defend the counterclaims along with Harmony. Orphalan SA v. Novitium On April 22, 2026, Orphalan SA filed a lawsuit against Novitium, alleging that Novitium’s actions in connection with the filing of Novitium’s ANDA No. 218493 infringe one or more claims of U.S. Patent Nos. 10,988,436, 11,072,577, 12,358,861 and 12,358,862. The case was filed in the United States District Court for the District of Delaware and assigned case no. 1:99-mc-09999. On June 22, 2026, Novitium filed its counterclaims and answer to the complaint. On July 10, 2026, Orphalan SA filed its answer to Novitium’s counterclaims. Novitium disputes any liability in this matter. In re Levoketoconazole Litigation On June 4, 2026, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited filed a lawsuit against Novitium and ANI, alleging that the defendants’ actions in connection with the filing of Novitium’s ANDA No. 221336 infringe one or more claims of U.S. Patent Nos. 11,020,393 (the “393 Patent”), 11,278,547 (the “547 Patent”), 11,903,940 and 12,377,096. The case was filed in the United States District Court for the District of New Jersey and assigned case no. 2:26-cv-06568 (“Civil Action No. 26-6568”). On July 13, 2026, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited filed a separate lawsuit against Novitium and ANI, alleging that the defendants’ actions in connection with the filing of Novitium’s ANDA No. 221336 infringe one or more claims of the 393 Patent and the 547 Patent. The case was filed in the United States District Court for the District of New Jersey and assigned case no. 2:26-cv-08641 (“Civil Action No. 26-8641”). On July 20, 2026, the Court entered a Joint Stipulation and Order of Consolidation that consolidated Civil Action No. 26-6568 and Civil Action No. 26-8641 into lead case Civil Action No. 2:26-cv-02044-JXN-JBC to become the In re Levoketoconazole Litigation. ANI and Novitium dispute any liability in this matter. Ranitidine Related Litigation Federal Court Multi District Litigation ANI and Novitium were named as defendants, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products, in In re: Zantac/Ranitidine NDMA Litigation (MDL No. 2924), filed in the United States District Court for the Southern District of Florida (the “MDL Court”). Plaintiffs allege that defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in brand-name Zantac or generic ranitidine and the alleged associated risk of cancer. While ANI was initially a defendant, the lead plaintiff attorneys voluntarily dismissed ANI as a defendant in the Master Complaint. On July 8, 2021, the MDL Court dismissed all claims by all plaintiffs against the generic drug manufacturers with prejudice, on preemption grounds. The MDL Court also dismissed all claims by all plaintiffs against the brand manufacturers on summary judgment. Plaintiffs appealed the MDL Court’s dismissals to the Eleventh Circuit Court of Appeals. On November 7, 2022, the Eleventh Circuit affirmed the MDL Court’s dismissal of cases brought by third-party payors. The Eleventh Circuit raised questions in the appeals of the other cases about the finality of the MDL Court’s judgments, which were resolved in September 2023. Plaintiffs filed opening briefs on April 10, 2024 and generics defendants filed their response on July 25, 2024. Plaintiffs filed reply briefs in September 2024. Oral arguments were heard on October 10, 2025, and a decision from the court is pending. ANI and Novitium dispute any liability in this matter. State Court Personal Injury Litigation California. The pending cases in California state court naming generic ranitidine manufacturers were transferred to an existing civil case coordination docket for pretrial proceedings (“JCCP”) in Alameda County. On September 21, 2023, plaintiffs filed a master complaint in the JCCP alleging strict liability, negligent failure to warn and general negligence, but not naming any generic defendants. Plaintiffs filed an amended master complaint on April 29, 2024 and filed a second amended master complaint on July 2, 2024. Defendants filed omnibus demurrers to the complaint. Novitium is currently named in one bellwether case (“Bautista”), one wave 2 case (“Austin”), one wave 3 case (“Rodarte”), three wave 5 cases, six wave 6 cases, and four wave 7 cases. The court heard arguments for the demurrers on August 22, 2024 and issued its final ruling on August 28, 2024, allowing some counts to survive. The surviving counts as to generic defendants include strict liability (manufacturing defect) and general negligence (storage and transport, failure to warn and product containers). Novitium filed its answer to the second amended master complaint on September 6, 2024. In December 2023, the Keller Postman firm filed a large number of short form complaints that name generic defendants. Novitium is named in 29 of the short form complaints which reference the claims for the master complaint, but Novitium has not been served. ANI is not named. On February 1, 2024, the generic defendants filed an omnibus demurrer challenging the sufficiency of the Keller Postman complaints, largely on the basis of preemption. On April 23, 2024, the California court sustained the demurrer in part, dismissing all design defect claims against the generic defendants with prejudice on preemption grounds, but the court otherwise granted plaintiffs an opportunity for leave to amend their other claims against the generic defendants. Plaintiffs filed amended short form complaints on September 20, 2024 and defendants filed responses on October 6, 2024. One case naming Novitium (Shlitz) has been set for trial to commence on October 19, 2026 and a second case naming Novitium (Rodriguez) has been set for trial to commence after June 2027. Novitium disputes any liability in these matters.

COMMITMENTS AND CONTINGENCIES

The majority of the Company’s leases as of June 30, 2026 are classified as operating leases. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company’s lease agreements do not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. Rent expense is recognized on a straight-line basis over the lease term. Operating lease ROU assets are included in other non-current assets and operating lease liabilities are included in accrued expenses and other and other non-current liabilities in the unaudited condensed consolidated balance sheets. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants.

Government Regulation

The Company’s products and facilities are subject to regulation by a number of federal and state governmental agencies, such as the Drug Enforcement Administration (“DEA”), the FDA, the Centers for Medicare and Medicaid Services, the Central Drugs Standard Control Organization, the Narcotics Control Bureau (“NCB”), and India’s Ministry of Health and Family Welfare. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of ANI’s products. The DEA and NCB maintain oversight over products that are considered controlled substances.

Four products, Esterified Estrogen with Methyltestosterone (“EEMT”), Opium Tincture, Thyroid Tablets, and Hyoscyamine, are marketed without approved NDAs or ANDAs. During the three and six months ended June 30, 2026, net revenues from commercial sales of these products totaled $5.7 million and $11.9 million, respectively. During the three and six months ended June 30, 2025, net revenues from commercial sales of these products totaled $6.1 million and $11.6 million, respectively.

The Company is involved, and from time to time may become involved, in various disputes, governmental and/or regulatory inquiries, investigations, government reimbursement related actions and litigation. These matters are complex and subject to significant uncertainties. While the Company believes that it has valid claims and/or defenses in the litigation and other matters described below, litigation is inherently unpredictable, particularly where the damages sought are substantial or indeterminate or when the proceedings, investigations or inquiries are in the early stages, and the outcome of the proceedings could result in losses, including substantial damages, fines, civil or criminal penalties and injunctive or administrative remedies. The Company intends to vigorously prosecute and/or defend these matters, as appropriate; however, from time to time, the Company may settle or otherwise resolve these matters on terms and conditions that it believes are in the Company’s best interests. Resolution of any or all claims, investigations, and legal proceedings, individually or in the aggregate, could have a material adverse effect on the results of operations and/or cash flows in any given accounting period or on the Company’s overall financial condition.

Unless otherwise disclosed, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. The Company records accruals for loss contingencies to the extent it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated.

From time to time, the Company may also be involved in other pending proceedings for which, in the opinion of management and based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to its results, and therefore remain undisclosed. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of management, become material, the Company will disclose such matters.

Furthermore, like many pharmaceutical manufacturers, the Company is periodically exposed to product liability claims. The prevalence of these claims could limit the Company’s coverage under future insurance policies or cause those policies to become more expensive, which could harm its business, financial condition, and operating results. Recent trends in the product liability and director and officer insurance markets are to exclude matters related to certain classes of drugs. The Company’s policies have been subject to such exclusions which place further potential risk of financial loss on the Company.

Legal fees for litigation-related matters are expensed as incurred and included in the consolidated statements of operations under the selling, general, and administrative expense line item.

Commercial Litigation

On March 4, 2024, ANI commenced a civil action against CG Oncology, Inc. f/k/a Cold Genesys, Inc. (“CG Oncology”) in the Superior Court of the State of Delaware (“Delaware Action”). ANI’s complaint alleges that, under an Assignment and Technology Transfer Agreement dated as of November 15, 2010 (the “November 2010 Agreement”), CG Oncology is liable to pay ANI a running royalty of 5% of the worldwide net sales of cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. On April 2, 2024, CG Oncology filed an answer and counterclaim (the “CGON Answer and Counterclaim”) and concurrently moved for judgment on the pleadings or, in the alternative, for partial summary judgment (the “Motion for Summary Judgment”). CG Oncology’s Motion for Summary Judgment sought judgment declaring that the November 2010 Agreement does not “oblige CGON to pay royalties after expiration of the latest-running assigned patent.” On April 25, 2024, ANI filed a reply to CG Oncology’s counterclaims, denying any liability to CG Oncology and asserting additional counterclaims against CG Oncology (“Reply Counterclaims”) for alleged breach of the November 2010 Agreement and, in the alternative, for unjust enrichment. On May 15, 2024, CG Oncology filed a reply to ANI’s counterclaims, denying any liability to ANI and generally maintaining the positions taken in the CGON Answer and Counterclaim. On November 18, 2024, the court denied CG Oncology’s Motion for Summary Judgment. On June 2, 2025, CG Oncology filed five motions for summary judgment seeking dismissal of all of ANI’s claims and counterclaims, including breach of the royalty payment provision, breach of good faith performance, breach of the implied covenant of good faith, and in the alternative, unjust enrichment. Also on June 2, 2025, ANI filed a motion for partial summary judgment seeking dismissal of CG Oncology’s counterclaims for unenforceability of the royalty payment provision under Brulotte, breach of good faith performance, breach of confidentiality and trade secret misappropriation. At a pretrial conference on July 16, 2025, the court granted CG Oncology’s motion for partial summary judgment on its Brulotte counterclaim and affirmative defense, but allowed the case to proceed on ANI’s counterclaim for unjust enrichment. The court also granted ANI’s motion for partial summary judgment, dismissing CG Oncology’s breach of confidentiality and trade secret misappropriation claims. The jury trial commenced in Delaware Superior Court on July 21, 2025. On July 29, 2025, a verdict was returned by the jury, finding that (1) the unenforceability of the royalty payment provision in the November 2010 Agreement did not affect the economic or legal substance of the transactions contemplated thereby in a manner that was materially adverse to ANI, and (2) awarding no damages to ANI on its unjust enrichment counterclaim. On August 12, 2025, ANI filed a motion for a new trial and for judgment as a matter of law. A hearing on the motions was held by the court on April 10, 2026. On July 16, 2026, the court denied ANI's motions. ANI intends to appeal these decisions to the Delaware Supreme Court.

On March 6, 2024, a complaint was filed against ANI by Acella Pharmaceuticals, LLC, in the United States District Court of Minnesota, asserting, among other things, false advertising under the Lanham Act, and unfair trade practices and false advertising under Minnesota law, relating to ANI’s natural desiccated thyroid tablets USP. The complaint seeks injunctive relief, actual and consequential damages, disgorgement of profits, and attorneys’ fees and costs. On June 7, 2024, ANI filed an amended answer to Acella’s complaint, denying all claims, and asserting certain affirmative defenses, and counterclaims against Acella for false advertising of its thyroid product marketed as NP Thyroid® Tablets, under the Lanham Act, and for deceptive trade practices under Minnesota and Georgia law. ANI seeks injunctive relief, compensatory damages, punitive damages and attorneys’ fees and costs. On April 15, 2026, ANI and Acella filed cross motions for summary judgment against each other’s respective claims. The parties have been unable to reach a settlement to date. Fact and expert discovery are now closed. A hearing is set for August 25, 2026 on the parties’ summary judgment motions. A trial date has not been set. ANI disputes any liability in this matter and continues to defend this lawsuit vigorously.

Patent Infringement Litigation

Harmony Biosciences Patent Litigation

On April 20, 2026, Harmony Biosciences Management, Inc. (“Harmony Management”), along with Novitium, as exclusive licensor of certain intellectual property to Harmony Management, including U.S. Patent No. 11,623,920 (the “920 Patent”), filed a lawsuit against AET Pharma US, Inc., AET Laboratories Private Limited, Alfred E. Tiefenbacher (GmbH & Co. KG) (collectively, “AET”), Sandoz Inc., Sandoz Private Limited, and Sandoz GmbH, alleging that the defendants’ actions in connection with the filing of AET’s ANDA No. 218892 infringe one or more claims of the 920 Patent. The case was filed in the United States District Court for the District of Delaware and assigned case no. 26-cv-00453-JLH.

On June 22, 2026, the defendants filed an answer to the complaint, along with counterclaims alleging various antitrust counterclaims against Harmony Management individually and against Harmony Management and Novitium jointly. On July 6, 2026, the parties stipulated that defendants Sandoz Private Limited and Sandoz GmbH be dismissed without prejudice, which stipulation was granted on July 7, 2026. On July 21, 2026, the defendants filed an amended answer updating the complaint to remove those parties.

Novitium intends to continue to pursue this matter and to vigorously defend the counterclaims along with Harmony.

Orphalan SA v. Novitium

On April 22, 2026, Orphalan SA filed a lawsuit against Novitium, alleging that Novitium’s actions in connection with the filing of Novitium’s ANDA No. 218493 infringe one or more claims of U.S. Patent Nos. 10,988,436, 11,072,577, 12,358,861 and 12,358,862. The case was filed in the United States District Court for the District of Delaware and assigned case no. 1:99-mc-09999. On June 22, 2026, Novitium filed its counterclaims and answer to the complaint. On July 10, 2026, Orphalan SA filed its answer to Novitium’s counterclaims.

Novitium disputes any liability in this matter.

In re Levoketoconazole Litigation

On June 4, 2026, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited filed a lawsuit against Novitium and ANI, alleging that the defendants’ actions in connection with the filing of Novitium’s ANDA No. 221336 infringe one or more claims of U.S. Patent Nos. 11,020,393 (the “393 Patent”), 11,278,547 (the “547 Patent”), 11,903,940 and 12,377,096. The case was filed in the United States District Court for the District of New Jersey and assigned case no. 2:26-cv-06568 (“Civil Action No. 26-6568”).

On July 13, 2026, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited filed a separate lawsuit against Novitium and ANI, alleging that the defendants’ actions in connection with the filing of Novitium’s ANDA No. 221336 infringe one or more claims of the 393 Patent and the 547 Patent. The case was filed in the United States District Court for the District of New Jersey and assigned case no. 2:26-cv-08641 (“Civil Action No. 26-8641”).

On July 20, 2026, the Court entered a Joint Stipulation and Order of Consolidation that consolidated Civil Action No. 26-6568 and Civil Action No. 26-8641 into lead case Civil Action No. 2:26-cv-02044-JXN-JBC to become the In re Levoketoconazole Litigation.

ANI and Novitium dispute any liability in this matter.

Ranitidine Related Litigation

Federal Court Multi District Litigation

ANI and Novitium were named as defendants, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products, in In re: Zantac/Ranitidine NDMA Litigation (MDL No. 2924), filed in the United States District Court for the Southern District of Florida (the “MDL Court”). Plaintiffs allege that defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in brand-name Zantac or generic ranitidine and the alleged associated risk of cancer. While ANI was initially a defendant, the lead plaintiff attorneys voluntarily dismissed ANI as a defendant in the Master Complaint. On July 8, 2021, the MDL Court dismissed all claims by all plaintiffs against the generic drug manufacturers with prejudice, on preemption grounds. The MDL Court also dismissed all claims by all plaintiffs against the brand manufacturers on summary judgment. Plaintiffs appealed the MDL Court’s dismissals to the Eleventh Circuit Court of Appeals. On November 7, 2022, the Eleventh Circuit affirmed the MDL Court’s dismissal of cases brought by third-party payors. The Eleventh Circuit raised questions in the appeals of the other cases about the finality of the MDL Court’s judgments, which were resolved in September 2023. Plaintiffs filed opening briefs on April 10, 2024 and generics defendants filed their response on July 25, 2024. Plaintiffs filed reply briefs in September 2024. Oral arguments were heard on October 10, 2025, and a decision from the court is pending.

ANI and Novitium dispute any liability in this matter.

State Court Personal Injury Litigation

California. The pending cases in California state court naming generic ranitidine manufacturers were transferred to an existing civil case coordination docket for pretrial proceedings (“JCCP”) in Alameda County. On September 21, 2023, plaintiffs filed a master complaint in the JCCP alleging strict liability, negligent failure to warn and general negligence, but not naming any generic defendants. Plaintiffs filed an amended master complaint on April 29, 2024 and filed a second amended master complaint on July 2, 2024. Defendants filed omnibus demurrers to the complaint. Novitium is currently named in one bellwether case (“Bautista”), one wave 2 case (“Austin”), one wave 3 case (“Rodarte”), three wave 5 cases, six wave 6 cases, and four wave 7 cases. The court heard arguments for the demurrers on August 22, 2024 and issued its final ruling on August 28, 2024, allowing some counts to survive. The surviving counts as to generic defendants include strict liability (manufacturing defect) and general negligence (storage and transport, failure to warn and product containers). Novitium filed its answer to the second amended master complaint on September 6, 2024.

In December 2023, the Keller Postman firm filed a large number of short form complaints that name generic defendants. Novitium is named in 29 of the short form complaints which reference the claims for the master complaint, but Novitium has not been served. ANI is not named. On February 1, 2024, the generic defendants filed an omnibus demurrer challenging the sufficiency of the Keller Postman complaints, largely on the basis of preemption. On April 23, 2024, the California court sustained the demurrer in part, dismissing all design defect claims against the generic defendants with prejudice on preemption grounds, but the court otherwise granted plaintiffs an opportunity for leave to amend their other claims against the generic defendants. Plaintiffs filed amended short form complaints on September 20, 2024 and defendants filed responses on October 6, 2024. One case naming Novitium (Shlitz) has been set for trial to commence on October 19, 2026 and a second case naming Novitium (Rodriguez) has been set for trial to commence after June 2027.

Novitium disputes any liability in these matters.