Alvogen Malta Operations Ltd.

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Alvogen Malta Operations Ltd. is a Malta-incorporated pharmaceutical company registered at Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Ġwann SGN 3000. Its parent structure is not fully public: in the 2019 Delaware litigation below, Alvogen admitted it is a wholly owned subsidiary of Alvogen Luxembourg, and that Alvogen Pine Brook LLC (Pine Brook, NJ) is its own wholly owned subsidiary. It sits within the Alvogen group, a private US-based specialty/generics pharmaceutical company founded in 2009 and headquartered in Morristown, NJ. Alvogen was formerly majority-owned by CVC Capital Partners and Temasek Holdings; in December 2025 Lotus Pharmaceutical Co., Ltd. (TWSE: 1795) completed the acquisition of Alvogen's US parent, making Alvogen a controlled subsidiary of Lotus. Group-size estimates vary widely by source (roughly 500–2,800 employees; revenue estimates from ~$700M to ~$1.1B for 2017), so no reliable current figure can be confirmed for this specific Malta entity.

Operations. Alvogen Malta is an operating pharmaceutical manufacturer/ANDA holder, not an NPE. It acts as applicant or named holder on abbreviated new drug applications filed with the FDA, using Alvogen Pine Brook LLC and Alvogen PB Research & Development LLC as US agents. FDA approval letters tie it to generic products including nateglinide tablets (generic Starlix), buprenorphine buccal film (generic Belbuca), nitrofurantoin capsules (Macrodantin), and sitagliptin phosphate products; it is also listed as a marketing-authorisation holder for EU products. The broader group develops, in-licenses, manufactures and markets generic, brand, OTC and specialty products, with US manufacturing in Norwich, NY.

Litigation posture. The tracked data shows 1 case, 0 as plaintiff and 1 as defendant — the classic profile of an operating company defending Hatch-Waxman patent suits, not a patent asserter. The single tracked matter was filed in the District of Delaware, a common ANDA venue, not the Eastern District of Texas.

Notable case. Merck Sharp & Dohme Corp. v. Alvogen Pine Brook LLC et al., No. 1:19-cv-00310-RGA (D. Del., filed Feb 13, 2019). Merck alleged that Alvogen's ANDA No. 205341, for generic sitagliptin phosphate (Janumet XR), infringed U.S. Patent No. 7,326,708; Alvogen counterclaimed for declaratory judgment of non-infringement and invalidity. The suit was consolidated into In re Sitagliptin Phosphate ('708 & '921) Patent Litigation, MDL No. 2902.