Defendant

Hetero Unit-V

1 case as defendant.

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

Company profile

Company overview. "Hetero Unit-V" (also styled Hetero Labs Limited, Unit-V) is not a standalone legal entity: Hetero Labs Limited's own Rule 7.1 corporate disclosure statements state that "Hetero Labs Limited Unit-V is not a distinct entity, but rather a division of Hetero Labs Limited." Hetero Labs is part of India's privately held Hetero group, founded in 1993 in Hyderabad, Telangana by Dr. B. Parthasaradhi Reddy (Bandi Parthasaradhi Reddy). Hetero Drugs Limited (incorporated 1993) and Hetero Labs Limited (1989) are the group's principal Indian entities and both serve as parents of the U.S. affiliate Hetero USA, Inc.; no publicly traded corporation owns 10% or more of any of them. Public sources put the wider group at over 20,000 employees, with Hetero Labs Limited reporting revenue around ₹16,500 crore for FY2025; Hetero's own sustainability reporting cites 18,000+ direct employees. These figures cover the group, not the single division.

Products / operations. Unit-V is a finished-dosage (formulation) manufacturing site at the TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahabubnagar District, Telangana. It produces oral solid-dosage generics across multiple therapeutic classes — antiretrovirals (e.g., abacavir/lamivudine, efavirenz/lamivudine/tenofovir combinations), oncology (lenalidomide, ibrutinib, gefitinib), cardiovascular, CNS/antipsychotic, and proton-pump inhibitor products. It is WHO-prequalified for several products and supplies the U.S. market largely through Camber Pharmaceuticals, Hetero's U.S. generic arm.

Patent-litigation posture. Operating company, not an NPE. In the tracked data it appears only as a defendant (0 plaintiff cases, 1 defendant case). It is a generic ANDA filer defending against brand-name patent holder suits, the standard Hatch-Waxman posture.

Notable case. Celgene Corporation v. Hetero Labs Ltd. et al., D.N.J. — Celgene's lenalidomide (Revlimid) ANDA litigation against Hetero over its proposed generic. Venue is the District of New Jersey, Celgene's home forum and a common venue for these ANDA suits, not plaintiff-friendly EDTX. Public filings describe related Celgene/Hetero lenalidomide actions and a 2021 consent judgment; the tracked docket is the single case in this database.

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.