Defendant
4 cases as defendant.
Company overview. Amneal Pharmaceuticals LLC is the operating entity of Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), a publicly traded, fully integrated generics and specialty pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel and publicly listed in 2018 after a reverse merger with Impax Laboratories, the company employs roughly 8,500–8,700 people and reported FY2024 net revenue of about $2.8 billion (≈$3.0 billion in FY2025). Public sources place its market cap in the $5.5–6.3 billion range.
Products / operations. Amneal develops, manufactures, and distributes a portfolio of roughly 280+ drug products across three segments: Affordable Medicines (retail generics, sterile injectables, and biosimilars — including oral solids, liquids, nasal sprays, transdermals, and ophthalmics), Specialty (branded CNS and endocrine products such as Rytary, Unithroid, and Ongentys), and AvKARE (pharmaceutical distribution to U.S. federal agencies including DoD and VA). It bills itself as the #4 U.S. generics portfolio by prescriptions and sales, with operations in the U.S., India, and Ireland.
Patent-litigation posture. Amneal is an operating company defending against a brand-owner suit — not an NPE. The tracked database shows one case, with Amneal as defendant and zero as plaintiff: a Hatch-Waxman/ANDA action filed in the District of Delaware (the typical venue for such cases), not a plaintiff-friendly forum like the Eastern District of Texas.
Notable case. In Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al. (D. Del., filed March 11, 2026), Neurelis — maker of Valtoco® (diazepam) nasal spray — sued Amneal over ANDA No. 219109 seeking approval of generic 7.5 mg and 10 mg diazepam nasal sprays, asserting patents covering intranasal benzodiazepine compositions and treatment methods (including U.S. Patent Nos. 12,337,061 and 12,521,400). The case was consolidated before Judge Maryellen Noreika with related Neurelis ANDA litigation against Padagis and Lupin. It reflects Amneal's routine generics business of filing Paragraph IV challenges to branded CNS products. Amneal also acquired biopharmaceutical firm Kashiv BioSciences in August 2026.
ANDA case against Amneal concerning Amneal's ANDA No. 219109 products. The complaint analysis identifies the '414 patent and related family members such as the '852 and '061 patents, and the case is consolidated with the lead Delaware action.
Jazz Pharmaceuticals, Inc. sued Amneal Pharmaceuticals LLC in D.N.J., asserting U.S. Patent 9,050,302 among others. The case was part of the consolidated Xyrem ANDA litigation before Judge Esther Salas and is closed.
Consolidated D.N.J. Xyrem action in which the '306 patent was folded in and construed in the court's Markman decision. Terminated by Amneal settlement on Oct 15, 2018.
Jazz sued Amneal over sodium oxybate ANDA No. 203631; Amneal's counterclaims expressly asserted that each claim of the '426 patent is invalid, confirming '426 was in suit. The outcome was not confirmed in the retrieved sources; the broader Jazz/Amneal Xyrem family was ultimately settled, but the '426 disposition specifically is unverified.