Commitments and Contingencies |
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| Commitments and Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies | Commitments and Contingencies Commitments Commercial Manufacturing, Collaboration, License, and Distribution Agreements The Company continues to seek to enhance its product line and develop a balanced portfolio of differentiated products through product acquisitions and in-licensing. Accordingly, the Company, in certain instances, may be contractually obligated to make potential future development, regulatory, and commercial milestone, royalty and/or profit-sharing payments in conjunction with collaborative agreements or acquisitions that the Company has entered with third parties. The Company has also licensed certain technologies or IP from various third parties. The Company is generally required to make upfront payments and other payments upon successful completion of regulatory or sales milestones. The agreements generally permit the Company to terminate the agreement with no significant continuing obligation. The Company could be required to make significant payments pursuant to these arrangements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to pay such amounts. Further, the timing of any future payment is not reasonably estimable. Refer to Note 4. Alliance and Collaboration for additional information. Certain of these arrangements are with related parties. Refer to Note 20. Related Party Transactions for additional information. Contingencies Legal Proceedings The Company’s legal proceedings are complex, constantly evolving, and subject to uncertainty. As such, the Company cannot predict the outcome or impact of its significant legal proceedings which are set forth below. Additionally, the Company manufactures and derives a portion of its revenue from the sale of pharmaceutical products in the opioid class of drugs and may therefore face claims arising from the regulation and/or consumption of such products. While the Company believes it has meritorious claims and/or defenses to the matters described below (and intends to vigorously prosecute and defend them), the nature and cost of litigation is unpredictable, and an unfavorable outcome of such proceedings could include damages, fines, penalties and injunctive or administrative remedies. For any proceedings where losses are probable and reasonably capable of estimation, the Company accrues a potential loss. When the Company has a probable loss for which a reasonable estimate of the liability is a range of losses and no amount within that range is a better estimate than any other amount, the Company records the loss at the low end of the range. While these accruals have been deemed reasonable by the Company’s management, the assessment process relies heavily on estimates and assumptions that may ultimately prove inaccurate or incomplete. Additionally, unforeseen circumstances or events may lead the Company to subsequently change its estimates and assumptions. Unless otherwise indicated below, the Company is unable at this time to estimate the possible loss or the range of loss, if any, associated with such legal proceedings and claims. Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs to defend or settle, borrowings under the Company’s debt agreements, restrictions on product use or sales, or otherwise harm the Company’s business. The ultimate resolution of any or all claims, legal proceedings or investigations are inherently uncertain and difficult to predict, could differ materially from the Company’s estimates and could have a material adverse effect on its results of operations and/or cash flows in any given accounting period, or on its overall financial condition. The Company currently intends to vigorously prosecute and/or defend these proceedings as appropriate. From time to time, however, the Company may settle or otherwise resolve these matters on terms and conditions that it believes to be in its best interest. An insurance recovery, if any, is recorded in the period in which it is probable the recovery will be realized. For the three months ended September 30, 2026, charges related to legal matters, net were $6.5 million, primarily consisting of a charge related to government investigations of $8.0 million, partially offset by immaterial net credits related to several matters. For the nine months ended September 30, 2026, charges related to legal matters, net were $15.2 million, primarily consisting of (i) a $21.2 million charge associated with certain states electing a 25% cash conversion in lieu of product under the Nationwide Opioids Settlement Agreement, partially offset by a $20.8 million discount recorded on the expected settlement payments as of the agreement’s effective date, (ii) net charges associated with antitrust class action litigation of $7.5 million, and (iii) charges related to government investigations of $8.0 million. These charges were partially offset by immaterial net credits related to several other legal matters. For additional information regarding the Nationwide Opioids Settlement Agreement, antitrust class action litigation, and government investigations, refer to the section Other Litigation Regarding the Company’s Business below. Liabilities for legal matters were comprised of the following (in thousands):
(1)As of September 30, 2026, the total current and long-term liabilities of $81.1 million for civil prescription opioid litigation were primarily comprised of an $80.6 million liability for the Nationwide Opioids Settlement Agreement effective January 23, 2026, as defined and described in the section Civil Prescription Opioid Litigation below. Of the $80.6 million accrued for this settlement agreement, $79.7 million was for cash payments and $0.9 million was for the supply of naloxone nasal spray. As of September 30, 2026, the remaining cash payments under the Nationwide Opioids Settlement Agreement, due on March 1 of each year, were as follows (in thousands):
(1)Amounts due in each of 2031 through 2034 include approximately $10.4 million of cash conversion payments associated with certain settling parties’ elections to receive cash in lieu of naloxone nasal spray under the Nationwide Opioids Settlement Agreement ($41.4 million in the aggregate). The discount-related imputed interest will be amortized to interest expense over the life of the liability using the effective interest method. Interest expense associated with the Nationwide Opioids Settlement Agreement for the three and nine months ended September 30, 2026 was immaterial. Refer to Note 19. Commitments and Contingencies in the Company’s Annual Report on Form 10-K for a general discussion of Medicaid Reimbursement and Price Reporting Matters and Patent Litigation. Other Litigation Related to the Company’s Business United States Department of Justice Investigations On May 15, 2023, Amneal Pharmaceuticals LLC (“Amneal”) received a Civil Investigative Demand (“CID”) from the Civil Division of the United States Department of Justice (the “Civil Division”) requesting information and documents related to the manufacturing and shipping of diclofenac sodium 1% gel labeled as “prescription only” after the reference listed drug’s label was converted to over-the-counter. In October 2024, the Company received supplemental CIDs seeking additional information related to the same subject matter. The Company is continuing to cooperate with the Civil Division’s investigation. However, no assurance can be given as to the timing or outcome of the investigation. In Re Generic Pharmaceuticals Pricing Antitrust Litigation Beginning in March 2016, purchasers of generic drugs filed multiple putative antitrust class action complaints against a substantial number of generic pharmaceutical manufacturers, including the Company, alleging an illegal conspiracy to fix prices, rig bids, and allocate markets and customers. They seek monetary damages and equitable relief, including disgorgement and restitution. Most of these lawsuits were consolidated in the United States District Court for the Eastern District of Pennsylvania (See In re Generic Pharmaceuticals Pricing Antitrust Litigation, MDL No. 2724 (E.D. Pa.)). Some purchasers filed similar lawsuits in state courts in Pennsylvania, Connecticut, and New York. The Company has filed several motions to dismiss these cases, and some of those motions remain pending. In 2019 and 2020, Attorneys General of 43 States and the Commonwealth of Puerto Rico named the Company in two complaints alleging a similar conspiracy and seeking similar relief. These cases are pending in the District of Connecticut. See Connecticut, et al. v. Teva Pharmaceuticals USA, Inc., et al., 3:19-cv-00710-MPS and Connecticut, et al. v. Sandoz, Inc. et al., 3:20-cv-00802-MPS. In Connecticut, et al. v. Sandoz, Inc. et al., on April 15, 2026, the Court granted the Company’s individual motion for summary judgment with respect to the states’ claim that the Company participated in an overreaching conspiracy involving more than 80 drugs and denied the Company’s motion with respect to an alleged conspiracy involving only one drug, phenytoin. The multi-district litigation (“MDL”) court selected Humana Inc. v. Actavis Elizabeth, LLC et al., No. 2:18-cv-03299-CMR (“Humana I”), which names Impax Laboratories, LLC (“Impax”) as a defendant, as a bellwether and set a trial for September 2026. On March 26, 2026, Impax filed an individual motion for summary judgment and four joint motions for summary judgment in Humana I. Those summary judgment motions were fully briefed on May 22, 2026 and remain pending. On August 4, 2026, the Court denied Defendants’ joint motion for partial summary judgment on statute of limitations grounds as to certain federal claims, and on September 28, 2026, it denied the motion as to certain state-law claims. Defendants’ joint summary judgment motion on damages was denied on August 19, 2026, and defendants’ joint summary judgment motion on overarching conspiracy was denied on August 26, 2026. On September 14, 2026, Defendants’ joint summary judgment motion on state-law claims was granted in part and denied in part. Impax’s individual motion for summary judgment remains pending. On September 2, 2026, the Court stayed proceedings and continued the trial date in light of a dispute regarding a possible conflict of interest involving one of the appointed special masters. The other MDL cases and the state court cases are in various stages of pleading and discovery. No other trials involving the Company have been set. Civil Prescription Opioid Litigation As a result of the Court’s Stipulation and Order dated February 26, 2026, pursuant to the settlement of the political subdivision cases in MDL 2804, the state and federal cases against the Company relating to the sale of prescription opioid pain relievers have been reduced from over 800 cases to less than 70 cases, comprised of 24 cases in MDL 2804 and other federal courts, and 42 state court cases. Plaintiffs in the remaining cases are political subdivisions (pending dismissal), schools, hospitals, pension funds, third-party payors, and individuals. Nearly all federal court cases are consolidated for pre-trial proceedings in Case No. 17-mdl-2804 (N.D. Ohio). There are no firm trial dates in the state-court cases. The New York, Alaska, and Maryland Attorneys General have withdrawn their subpoenas seeking information regarding the Company’s business concerning opioid-containing products. In 2023, the Company reached settlements with the New Mexico Attorney General and West Virginia political subdivisions and a settlement with a group of private hospitals in Alabama. On March 30, 2026, the court in Alabama dismissed the hospital cases against the Company pursuant to the settlement agreement. In late April 2024, the Company reached a nationwide settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases filed and that might have been filed by state Attorneys General, political subdivisions and Native American tribes. In September 2025, the Native American tribal participation reached a sufficient percentage to effectuate the tribal settlement. On January 23, 2026, the Company determined that it will make effective its nationwide agreement to settle a substantial majority of the opioids-related claims brought against the Company by various states and subdivisions (the “Nationwide Opioids Settlement Agreement”), having previously secured sufficient participation by those states and subdivisions, including all eligible state and territorial Attorneys General and all subdivisions that previously sued the Company. The Nationwide Opioids Settlement Agreement became effective on January 29, 2026, and the Company made its first installment payment of $23.8 million to the settlement administrator on that date. An additional installment payment of $12.1 million was made on February 26, 2026. The settlement is payable through 2034. Under the settlement, the Company agreed to pay up to $92.5 million in cash and provide $177.4 million (valued at $125/twin pack) in naloxone nasal spray to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive 25% of the naloxone nasal spray’s value (up to $44.4 million) in cash during the last four years of the ten-year payment term, which could increase the total amount of cash the Company would pay up to $136.9 million. In March 2026, five states elected to receive $11.6 million in free naloxone nasal spray with the remaining states electing to receive the 25% cash conversion. As a result, and assuming other states do not subsequently decide to instead receive settlement product, Amneal will pay $41.4 million in cash in equal distributions of $10.4 million from 2031 to 2034. Including these cash conversion payments, the Company’s total cash payments under the Nationwide Opioids Settlement Agreement will be $133.5 million. Refer to the section Legal Proceedings above for amounts charged to the statements of operations for the three and nine months ended September 30, 2026 and liabilities as of September 30, 2026 and December 31, 2025, associated with civil prescription opioid litigation. For the remaining cases not covered by the Nationwide Opioids Settlement Agreement, primarily brought by other hospitals, schools and individuals, the Company did not record a liability as of September 30, 2026 and December 31, 2025 because it concluded that a loss was not probable and estimable. During July 2025, the Company deposited an aggregate of $24.2 million into dedicated accounts as a step in the process to finalize a definitive settlement agreement. These deposits, which were classified as restricted cash in the Company’s consolidated balance sheet as of December 31, 2025, remained the property of the Company until a definitive settlement agreement was reached and the funds were used to make the first installment payment under the Nationwide Opioids Settlement Agreement. Accordingly, no related restricted cash balance remained as of September 30, 2026. United States Department of Justice / Drug Enforcement Administration Subpoenas On July 7, 2017, Amneal Pharmaceuticals of New York, LLC received an administrative subpoena issued by the Long Island, NY District Office of the Drug Enforcement Administration (the “DEA”) requesting information related to compliance with certain recordkeeping and reporting requirements. On or about April 12, 2019 and May 28, 2019, the Company received grand jury subpoenas from the U.S. Attorney’s Office for the Eastern District of New York (the “USAO”) relating to similar topics concerning the Company’s suspicious order monitoring program and its compliance with the Controlled Substances Act. The Company has been cooperating with the USAO in responding to the subpoenas. The Company entered into tolling agreements with respect to potential criminal charges through May 15, 2026. The Company entered into tolling agreements with respect to potential civil claims through November 15, 2024. It is not possible to determine the exact outcome of these investigations. On December 21, 2025, the Company received an administrative subpoena from the DEA relating to sales of controlled substances to Dixon Shane, LLC d/b/a R&S Northeast LLC (“R&S Northeast”), an indirect subsidiary that distributes generic pharmaceuticals manufactured by Amneal and others. On the same date, R&S Northeast received an administrative subpoena from the DEA relating to various policies and procedures relating to controlled substances and controlled substance order monitoring, as well as other information relating to current and former customers. The Company and R&S Northeast have been cooperating with DEA and responding to the subpoenas. It is not possible to determine the exact outcome of this investigation. Ranitidine Litigation The Company was named, along with numerous other brand and generic pharmaceutical manufacturers, wholesale distributors, retail pharmacy chains, and repackagers of ranitidine-containing products in a federal MDL (In re Zantac/Ranitidine NDMA Litigation (MDL No. 2924), Southern District of Florida). Plaintiffs alleged defendants failed to disclose and/or concealed the alleged inherent presence of N-Nitrosodimethylamine (or “NDMA”) in ranitidine products and the alleged associated risk of cancer. The MDL court’s dismissal of claims by all plaintiffs against the Company and other generic drug manufacturers on preemption grounds is on appeal in the 11th Circuit. Plaintiffs filed their merits brief on April 10, 2024. The generic drug manufacturers, including the Company, filed their briefs on July 25, 2024. Plaintiffs’ reply brief was filed November 8, 2024. The briefing also addresses the MDL court’s December 6, 2022 exclusion of plaintiff’s general causation experts. The 11th Circuit heard oral argument on October 10, 2025. The timeline for the 11th Circuit Court of Appeals’ rulings is uncertain. The Company has also been named in state court cases in four states. The Company filed motions to dismiss those cases. On August 17, 2023, the judge in the consolidated Illinois state court cases granted the motion to dismiss all such cases in which the Company had been named, holding all claims preempted. The Company has reached an agreement, which is not material, to settle the 95 cases pending against it in California state court. The process for completing the settlement, which the Company does not expect to be material, is in progress. There are no trial dates involving the Company in any of the state court cases. Metformin Litigation Beginning in 2020, Amneal was named as a defendant in several putative class action lawsuits filed and consolidated in the United States District Court for the District of New Jersey, seeking compensation for economic loss allegedly incurred in connection with their purchase of generic metformin allegedly contaminated with NDMA. See In Re Metformin Marketing and Sales Practices Litigation (No. 2:20-cv-02324-MCA-MAH) (“In re Metformin”). On January 30, 2026, the Court issued an Order granting in part and denying in part Defendants’ motion to dismiss the Fourth Amended Complaint. Discovery is ongoing. On March 29, 2021, a plaintiff filed a complaint in the United States District Court for the Middle District of Alabama asserting claims against manufacturers of valsartan, losartan, and metformin based on the alleged presence of nitrosamines in those products. The only allegations against the Company concern metformin (See Davis v. Camber Pharmaceuticals, Inc., et al., C.A. No. 2:21-00254 (M.D. Ala.) (the “Davis Action”)). On May 5, 2021, the United States Judicial Panel on Multidistrict Litigation transferred the Davis Action into the In re: Valsartan, Losartan, and Irbesartan Products Liability Litigation MDL for pretrial proceedings. UFCW Local 1500 Welfare Fund v. Takeda Pharmaceuticals U.S.A., Inc. On November 14, 2023, UFCW Local 1500 Welfare Fund and other health plans filed a purported class action lawsuit in the United States District Court for the Southern District of New York against multiple manufacturers, including the Company, alleging an illegal conspiracy to restrict output of generic COLCRYS®. See UFCW Local 1500 Welfare Fund et al. v. Takeda Pharma. U.S.A., Inc. et al, No. 1:23-cv-10030 (S.D.N.Y.). On February 28, 2024, Takeda Pharmaceuticals U.S.A., Inc. filed a motion to transfer the case to the United States District Court for the Eastern District of Pennsylvania. The case was transferred on April 28, 2026. See UFCW Local 1500 Welfare Fund et al. v. Takeda Pharma U.S.A., Inc., et al. No. 2:26-cv-3122 (E.D. Pa.). Defendants’ motion to dismiss the case was filed on June 9, 2026. That motion is fully briefed and is pending before the Court. Indian Tax Authority Matters Amneal Pharmaceuticals Pvt. Ltd. and RAKS Pharmaceuticals Pvt. Ltd., which are subsidiaries of the Company, are currently involved in litigations with Indian tax authorities concerning Central Excise Tax, Service Tax, Goods & Services Tax, and Value Added Tax for various periods of time between 2014 and 2017. These subsidiaries have contested certain of these assessments, which are at various stages of the administrative process. The Company strongly believes its Indian subsidiaries have meritorious defenses in the matter. Guaifenesin Litigation On June 27, 2025, CVS Pharmacy, Inc. (“CVS”), which Amneal is defending, was named as a defendant in a putative consumer class action lawsuit in the United States District Court for the Northern District of Illinois, alleging that generic guaifenesin products sold by CVS (and manufactured by Amneal) contain benzene through the use of carbomer, an inactive ingredient. See Hatfield v. CVS Health Corporation, No. 1:25-cv-7248 (N.D. Ill.). On September 3, 2026, the Court granted CVS’s motion to dismiss without prejudice. Plaintiff filed a notice of voluntary dismissal with prejudice on October 8, 2026, and the case has been terminated. Amneal Pharmaceuticals LLC et al. v. Sandoz Inc. On November 25, 2024, the Company and Impax received the first of five notice letters from Sandoz Inc. (“Sandoz”) stating that Sandoz had filed an ANDA with the FDA seeking approval to market generic versions of CREXONT®, an extended-release oral capsule formulation of carbidopa and levodopa for the treatment of Parkinson’s disease. The notice letters included a Paragraph IV certifications alleging that certain patents covering CREXONT® are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of Sandoz’s generic product. In response to these notice letters, on January 7, 2025, the Company and Impax filed a first patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, Case No. 3:25-cv-00181-GC-TJB. The filing of this lawsuit triggered a 30-month stay of FDA approval of the Sandoz ANDA from the date of receipt of the notice letter. CREXONT® is also subject to a regulatory exclusivity until August 7, 2027. On June 20, 2025, the Company and Impax filed another patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, captioned Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 2:25-11981-GC-TJB. On November 12, 2025, the Company and Impax filed another patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey, captioned Amneal Pharmaceuticals LLC et al. v. Sandoz Inc., D.N.J. 2:25-17384-GC-TJB. On October 9, 2026, the Company, Impax, and Sandoz entered into a settlement and license agreement to resolve their disputes. Under the terms of that agreement, the Company and Impax granted Sandoz a license to begin selling generic versions of CREXONT® on December 21, 2037, or earlier under certain circumstances. On November 3, 2026, the three above lawsuits were dismissed without prejudice. Amneal Pharmaceuticals LLC et al. v. Alembic Pharmaceuticals Ltd. On May 26, 2026, the Company and Impax received a notice letter from Alembic Pharmaceuticals Ltd (“Alembic”) stating that it had filed an ANDA with the FDA seeking approval to market generic versions of CREXONT®, an extended-release oral capsule formulation of carbidopa and levodopa for the treatment of Parkinson’s disease. The notice letter included Paragraph IV certifications alleging that certain patents covering CREXONT® are invalid, unenforceable or will not be infringed by the manufacture, use or sale of Sandoz’s generic product. In response to the notice letter, on July 2, 2026, the Company and Impax filed an infringement lawsuit against Alembic in the U.S. District Court for the District of Delaware, Case No. 26-cv-00798. This lawsuit is currently in the initial pleadings and discovery stage. The filing of this lawsuit triggered a 30-month stay of FDA approval of the Alembic ANDA from the date of receipt of the notice letter. CREXONT® is also subject to a regulatory exclusivity until August 7, 2027. Carickhoff v. Amneal Pharmaceuticals, Inc., et al. On May 7, 2025, the Liquidating Trustee on Behalf of the Vyera Liquidating Trust Established Under the Subchapter V Plan of Reorganization of debtors Vyera Pharmaceuticals, LLC and Phoenixus AG filed an adversary proceeding in the United States Bankruptcy Court for the District of Delaware against the Company and Impax, seeking to recover approximately $55.4 million in allegedly fraudulent transfers made by the debtors to Impax to purchase the drug Daraprim in 2015. (See Carickhoff v. Amneal Pharmaceuticals, Inc, et al., Adv. Pro. No. 25-50903-JKS (Bankr. D. Del.)). Defendants filed a motion to dismiss the complaint on September 9, 2025. That motion is fully briefed and is pending before the Court. Shareholder Litigation Related to Agreement to Acquire Kashiv Biosciences, LLC Two complaints were filed by purported shareholders of the Company against the Company and certain directors and officers of the Company related to the Company’s agreement to acquire Kashiv Biosciences, LLC. The complaints were captioned: (i) Johnson v. Amneal Pharmaceuticals, Inc., et al., No. 654043/2026 (N.Y. Sup. Ct. July 8, 2026); and (ii) Kent v. Amneal Pharmaceuticals, Inc., et al., No. 654067/2026 (N.Y. Sup. Ct. July 9, 2026) (collectively, the “Complaints”). The Complaints sought to enjoin the defendants from proceeding with the Kashiv Acquisition unless the defendants disclosed certain purportedly material information alleged to have been omitted from the definitive proxy statement related to the solicitation of shareholder approval of the transaction and sought rescission of the Kashiv Acquisition and/or damages if the Kashiv Acquisition was consummated. Plaintiffs did not serve or otherwise pursue the Complaints, and the Kashiv Acquisition closed on August 10, 2026. Refer to Note 2. Acquisition for information about the Kashiv Acquisition. Value Drug Company v. Amneal Pharmaceuticals, Inc. On July 27, 2026, Value Drug Company filed a purported class action lawsuit on behalf of itself and other direct purchasers of RYTARY® or generic versions of RYTARY® in the Northern District of California alleging that Amneal and Impax illegally conspired with generic manufacturers Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited to suppress price competition for RYTARY®. See Value Drug Company v. Amneal Pharmaceuticals LLC et al, No. 5:26-cv-7780 (N.D. Cal.). Value Drug Company filed an amended complaint on September 17, 2026. Defendants’ motion to dismiss the amended complaint is due on November 18, 2026.
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