Defendant

Hetero USA

1 case as defendant.

Cases
1
Active
0
1 closed
Filed
—
Top venue
D N J
1 case

Company profile

Hetero USA Inc. is the U.S. subsidiary of the privately held Indian pharmaceutical group known as Hetero (flagship entity Hetero Labs Limited, incorporated 1989 and formerly Pharmasia Laboratories; the group brand dates to 1993). Hetero USA is a Delaware corporation with a principal U.S. place of business at 1035 Centennial Avenue, Piscataway, New Jersey. Per its own corporate disclosure filings, it is 50/50 owned by Hetero Labs Ltd. and Hetero Drugs Ltd.; no publicly traded company holds 10% or more. It is a closely held, non-listed group. The wider Hetero Group reports roughly 20,000–30,000 employees and operates ~36 manufacturing sites; Hetero Labs Limited alone disclosed ~₹16,500 crore revenue for FY2025 (secondary sources, The Company Check / CARE Ratings). It is not public and has no ticker.

Operations. Hetero is a generic and contract pharmaceutical manufacturer. Core lines are active pharmaceutical ingredients (APIs) — it is frequently described as the world's largest producer of anti-retroviral APIs — and finished dosage formulations (generics) across cardiovascular, oncology, HIV, and other therapies. Hetero USA functions mainly as the group's U.S. commercial and regulatory arm: it acts as U.S. regulatory agent for Hetero Labs units and distributes/sells Hetero generic products in the U.S. market.

Litigation posture. Hetero USA appears in the tracked data solely as a defendant (0 plaintiff cases, 1 defendant case), which is the profile of an operating company defending products-liability-style ANDA suits rather than a patent assertion entity. Its cases are brought by branded pharmaceutical manufacturers enforcing patents against generic filers; the venue here is the District of New Jersey (D.N.J.), which is habitual for Hatch-Waxman pharmaceutical litigation, not a plaintiff-friendly patent-assertion district.

Notable case. The single tracked matter is Celgene Corporation v. Hetero Labs Ltd. et al., D.N.J., a Hatch-Waxman/Paragraph IV dispute in which Hetero entities are defendants responding to a branded manufacturer's infringement claims tied to an Abbreviated New Drug Application. Related public records also show Hetero entities in other ANDA disputes (e.g., Ingenus Pharmaceuticals v. Hetero USA) and multi-district valsartan products-liability litigation. No patent-assertion funding or NPE characteristics are indicated.

Celgene Corporation v. Hetero Labs Ltd. et al.

settled
Docket:
2:17-cv-03387
Court:
D.N.J.

Celgene brought a §271(e)(2) ANDA action against Hetero in D.N.J. regarding the '428 patent. Hetero counterclaimed for declaratory judgment of invalidity/non-infringement of the '428 patent; the court issued a Markman ruling on 'treating multiple myeloma' in the '262, '3,939 and '428 patents, and the case was resolved by settlement.