Zydus Pharmaceuticals (USA) Inc.

Zydus Pharmaceuticals (USA) Inc. is the U.S. subsidiary of Zydus Lifesciences Ltd., a global pharmaceutical company headquartered in Ahmedabad, India. Incorporated in New Jersey in 2003, the U.S. entity has its corporate office in Pennington, New Jersey, and began its first commercial launch in 2005. Zydus Pharmaceuticals is a privately held subsidiary of Zydus Lifesciences, which is publicly traded on India's National Stock Exchange (NSE) and Bombay Stock Exchange (BSE) under the ticker ZYDUSLIFE. As of 2022, the U.S. subsidiary had approximately 193 employees.

Zydus Pharmaceuticals is an operating company focused on the marketing and distribution of generic and authorized generic pharmaceutical products in the United States. The company's portfolio includes over 500 SKUs, making it the fifth-largest unbranded generic corporation in the U.S. based on dispensed prescriptions. Its product lines cover a wide variety of FDA-approved medications in dosage forms such as tablets, capsules, injectables, ointments, and oral suspensions. The company is expanding its offerings in complex generics, including modified-release oral solids, transdermals, and injectables.

The company's patent litigation posture is that of an operating company defending against patent infringement allegations. The provided data shows Zydus Pharmaceuticals as a defendant in one tracked case and as a plaintiff in none. This defendant-only profile is typical for generic drug manufacturers, which often face litigation from brand-name pharmaceutical companies upon seeking FDA approval for generic versions of existing drugs.

The tracked case, Astellas Pharma Inc. et al. v. Zydus Pharmaceuticals (USA) Inc. et al., was filed on October 11, 2024, in the U.S. District Court for the District of New Jersey. This type of lawsuit is common in the pharmaceutical industry under the Hatch-Waxman Act, where a brand-name drug manufacturer sues a generic manufacturer for patent infringement after the generic company files an Abbreviated New Drug Application (ANDA) with the FDA. Zydus has a significant history of such filings, with over 280 approved ANDAs and more than 75 pending approval.