Defendant

Alembic Pharmaceuticals, Inc.

2 cases as defendant.

Cases
2
Active
0
2 closed
Filed
2022
Top venue
D. Delaware
1 case

Company profile

Alembic Pharmaceuticals, Inc. is the U.S. subsidiary of Alembic Pharmaceuticals Limited, an Indian pharmaceutical group. The Inc. entity is a Delaware corporation with its principal U.S. office at 750 Route 202, Bridgewater, New Jersey; court filings describe it as a wholly owned subsidiary of Alembic Global Holding SA, which in turn is wholly owned by Alembic Pharmaceuticals Limited. The parent is headquartered in Vadodara, Gujarat; its corporate history dates to 1907 (the listed entity was incorporated in 2010) and it trades on the NSE/BSE under APLLTD. It is public, with roughly 15,000–20,000 employees depending on source and consolidated revenue of about ₹6,672 crore in FY25 (~US$800M).

Operations. The group is a vertically integrated generics, branded-generics and API manufacturer. Its three divisions are international generics (oral solids, dermatology, ophthalmology, general and oncology injectables, supplied from five+ U.S. FDA-approved plants in India, plus the Aleor Dermaceuticals dermatology subsidiary), Indian branded formulations (gynaecology, anti-diabetic, ophthalmology, dermatology, anti-infectives, cough/cold and animal health, sold via a ~5,500-person field force), and active pharmaceutical ingredients/intermediates. Alembic reports 220+ cumulative U.S. ANDA approvals and 260+ filings; the U.S. front-end subsidiary markets generic solid oral, dermatology and ophthalmic products.

Litigation posture. Alembic is an operating company, not an assertion entity: it appears once in the tracked data, as a defendant (0 plaintiff-side suits). The suit is a standard Hatch-Waxman ANDA action in the U.S. District Court for the District of Delaware — a conventional pharmaceutical venue, not a plaintiff-friendly NPE district.

Notable case. Array BioPharma, Inc. v. Alembic Pharmaceuticals Limited et al., No. 1:22-cv-01277 (D. Del., filed 2022-09-28), concerned six patents covering binimetinib (Mektovi) formulations and combination use with encorafenib, triggered by Alembic's ANDA No. 217678 for 15 mg binimetinib tablets. Array is a Pfizer subsidiary. Alembic counterclaimed; Alembic Pharmaceuticals, Inc. was dismissed from the case by stipulation in November 2022. The action was dismissed in June 2025 under a settlement and license agreement barring U.S. marketing of the accused product. Alembic later received tentative FDA approval for binimetinib 45 mg as sole first applicant.

Array BioPharma, Inc. v. Alembic Pharmaceuticals Limited et al.

settled
Docket:
1:22-cv-01277-GBW
Filed:
2022-09-28
Terminated:
2025-06-10

Hatch-Waxman ANDA litigation brought by Array BioPharma against Alembic over generic binimetinib 15 mg tablets (ANDA No. 217678). The case was terminated by stipulated dismissal after a confidential settlement and license agreement, expressly not an adjudication on the merits, with no finding of infringement, invalidity, or unenforceability. A May 28, 2024 stipulated order addressed certain claims but did not become a final, appealable judgment.