Defendant

Gland Pharma Limited

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
2022
Top venue
D. New Jersey
1 case

Company profile

Gland Pharma Limited (NSE/BSE: GLAND; BSE code 543245) is an Indian sterile-injectables manufacturer headquartered in Hyderabad, Telangana, founded in 1978 by PVN Raju. It listed on the NSE and BSE in November 2020 and is a subsidiary of Shanghai Fosun Pharmaceutical (Fosun Pharma Industrial Pte. Ltd.), which acquired a majority stake in 2017 and holds roughly 52%. Public sources put headcount at approximately 4,200–4,800 employees; FY2024 consolidated revenue was ₹56.6 billion (about US$680 million), with FY2025 revenue near ₹56.2 billion and market capitalization in the ₹300–410 billion range (Investing.com/MarketScreener; Fortune India; TipRanks). Figures vary by source and fiscal-year definition.

Products and operations. Gland develops and manufactures generic sterile injectables on a business-to-business basis, with a focus on complex injectables, first-to-file products, NCE-1s and 505(b)(2) filings. Delivery formats include liquid and lyophilized vials, pre-filled syringes, ampoules, bags and drops; key molecules include heparin sodium, enoxaparin sodium, rocuronium bromide and daptomycin, across anti-infective, anti-neoplastic, ophthalmic, hormonal and other therapeutic categories. It operates plants in Hyderabad, Visakhapatnam and Dundigal, and acquired France-based Cenexi in 2024 for European manufacturing. The U.S. and Europe accounted for the majority of FY2024 revenue.

Patent-litigation posture. Gland is an operating company—not an NPE—and appears in the database solely as a defendant (0 plaintiff, 1 defendant case). The single tracked matter, Helsinn Healthcare S.A. v. Gland Pharma Limited, was a Hatch-Waxman ANDA suit filed in the District of New Jersey on 18 July 2022 over Gland's Paragraph IV certification for generic fosnetupitant/palonosetron (brand Akynzeo). The parties entered a consent judgment and dismissal with prejudice in January 2023.

Context. Gland's U.S. patent exposure has centered on ANDA/Paragraph IV litigation in the District of New Jersey, a venue Helsinn's complaint noted Gland has repeatedly submitted to; the complaint also referenced prior D.N.J. suits brought by Aerie, La Jolla, Fresenius Kabi, Merck, Medicure and Chiesi. No U.S. plaintiff-side assertions by Gland are recorded.

Helsinn Healthcare S.A. v. Gland Pharma Limited

consent judgment and dismissal
Docket:
3:22-cv-04635
Filed:
2022-07-18
Terminated:
2023-01-19

Helsinn sued Gland under the Hatch-Waxman Act over Gland's ANDA No. 217374 for generic fosnetupitant/palonosetron IV product, asserting ten patents including U.S. 10,828,297; the action was also cited in some sources as 2:22-cv-04635. It was resolved by consent judgment and dismissal order in January 2023, with Gland admitting technical infringement under 35 U.S.C. § 271(e)(2)(A) and enjoined from marketing the ANDA product until a redacted date; Gland's invalidity/non-infringement counterclaims were not adjudicated.