Defendant

Hetero Labs Ltd.

4 cases as defendant.

Cases
4
Active
0
4 closed
Filed
2017–2019
Top venue
D. New Jersey
3 cases

Company profile

Hetero Labs Limited (HLL) — commonly "Hetero" — is an Indian pharmaceutical manufacturer headquartered at Hetero Corporate, Sanath Nagar, Hyderabad, Telangana. Incorporated on 10 March 1989, it is the flagship company of the privately held Hetero Group (the group's own materials date its founding to 1993–94). HLL is a closely held, unlisted public limited company, 100% owned by promoters and associates; founder-chairman Dr. B. Partha Saradhi Reddy and managing director Vamsi Krishna Bandi lead it. CARE Ratings reported FY24 consolidated operating income of ₹14,476 crore, and registry filings show FY25 revenue of roughly ₹16,537 crore. Reported headcount ranges from about 7,300 (EPFO filings, Nov 2024) to about 9,300 (Tracxn, 2026), so treat size figures as approximate.

Operations. HLL manufactures active pharmaceutical ingredients (APIs) and finished dosage formulations, biosimilars, and custom pharmaceutical services, with roughly 500 products across about 20 therapeutic areas — antiretrovirals/HIV (its best-known franchise), antivirals, cardiovascular, CNS and oncology. It operates 10 manufacturing units, six of them US FDA-approved, and has filed 235 ANDAs (141 approved) at company level. It also markets prescription drugs in India through affiliate Hetero Healthcare, and in 2026 launched generic injectable semaglutide under the brands Truglyx, Rolmodl and Moto G.

Litigation posture. HLL is an operating company and a pure defendant in the tracked data: 0 cases as plaintiff, 2 as defendant, both in the District of New Jersey — not a plaintiff-friendly NPE venue. This is the classic Paragraph IV / Hatch-Waxman profile of a generic manufacturer being sued by a brand owner rather than an entity asserting acquired patents.

Notable cases. Both tracked suits are Celgene Corporation v. Hetero Labs Ltd. et al. (D.N.J.), the 2017 case filed 11 May 2017 alongside an earlier-filed action. These are ANDA infringement suits brought by Celgene over its lenalidomide (Revlimid) patents, involving Hetero entities including Hetero Unit-V and Hetero USA. Celgene's Revlimid patent litigation against Hetero and other generics has separately been the subject of purchaser-side antitrust litigation, but no outcome of the Hetero suits is confirmed here.

Filing activity

2017: 1 case'17'182019: 2 cases2'19
Cases filed per year naming Hetero Labs Ltd. as defendant.

Celgene Corp. v. Hetero Labs Ltd.

settled
Filed:
2019-07-16
Patents:8404717

Celgene asserted the '717 patent, along with other patents, against Hetero Labs Ltd. et al. The case was settled or otherwise resolved as part of the serial sham-litigation settlements alleged in the antitrust MDL; the exact civil-action number was not confirmed.

Celgene Corp. v. Hetero Labs Ltd. et al.

terminated
Docket:
2:17-cv-03387
Filed:
2017-05-11
Terminated:
2021-08-19
Patents:8828427

Hatch-Waxman ANDA litigation. The '427 was expressly named among the patents-in-suit, but Celgene withdrew its '427 infringement claims. Consolidated/coordinated for claim construction with 17-cv-03159. Case terminated 2021-08-19.

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.