Defendant

GAVIS Pharma LLC

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
—
Top venue
D. New Jersey
1 case

Company profile

GAVIS Pharmaceuticals LLC (named as "Gavis Pharma LLC" in court filings, and affiliated with sister company Novel Laboratories, Inc.) was a privately held US generic drug developer and manufacturer based at 400 Campus Drive, Somerset, New Jersey. It was founded in 2006–2007 by Dr. Veerappan Subramanian, who was president and CEO; Lupin Ltd.'s acquisition materials state it had roughly 250 New Jersey employees and FY2014 sales of about $96 million.

Products / operations. Gavis developed, manufactured, packaged and distributed niche generic prescription pharmaceuticals, with stated strengths in controlled substances (CII–CV), dermatology, colonoscopy preparations (Lupin materials cite >40% market share), nasal sprays, liquids and modified-release oral dosage forms. Its Somerset plant produced tablets, capsules and liquids. At the time of acquisition it reported roughly 62–66 ANDAs pending FDA approval and a 65+ product pipeline, including Paragraph IV challenges and first-to-file candidates.

Ownership. Lupin Ltd. agreed in July 2015 to acquire Gavis and Novel Laboratories for about $880 million; the deal closed in March 2016 after an FTC consent order required divestiture of two products (generic doxycycline monohydrate capsules and generic mesalamine ER capsules) to G&W Laboratories. Gavis is now part of Lupin's US generics business, and the Somerset site became Lupin's first US manufacturing facility. Its current independent legal status could not be verified.

Litigation posture. Gavis appears once in our data, solely as a defendant (0 cases as plaintiff) — the profile of an operating generic manufacturer, not a patent assertion entity. The tracked matter is a Hatch-Waxman ANDA suit, not an NPE assertion.

Notable case. Helsinn Healthcare S.A. et al. v. GAVIS Pharma LLC, No. 3:15-cv-01228 (D.N.J., filed Feb. 13, 2015). Helsinn and Roche Palo Alto sued over Gavis's Paragraph IV certification in ANDA No. 207364 for generic palonosetron HCl injection (0.25 mg/5 mL), the generic of Helsinn's Aloxi, asserting the '724, '725, '424, '219 and '094 patents. The case ended in a consent judgment and dismissal order on Aug. 25, 2015. Venue reflects Helsinn's consolidation of Aloxi ANDA suits in New Jersey rather than the Eastern District of Texas.