Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd.
settled- Docket:
- 1:21-cv-01006
Settled by consent judgment; unless specifically authorized under the settlement agreement, Annora is enjoined from infringing the patent-in-suit.
Defendant
1 case as defendant.
Annora Pharma Private Limited (brand "Annora Pharma") is an Indian generic-drug manufacturer incorporated on 26 November 2015 under CIN U24100TG2015PTC101939. Its registered office and manufacturing site are at Sy. No. 261, Annaram Village, Gummadidala Mandal, Sangareddy District, Telangana, India (PIN 502313). It is a private limited subsidiary of Hetero Labs Limited (Hetero Group), which ultimately owns its ANDAs; U.S. affiliate Hetero USA, Inc. acts as its regulatory agent and U.S. sales arm. Annora is not publicly traded. Third-party data (PharmaDB) lists roughly 593 employees, while Registrar of Companies filings report FY2025 revenue of about ₹1,494 crore (up ~22% YoY); customs aggregates put 2025 exports near $170 million. These figures come from third-party/regulatory aggregators, not audited company statements.
Operations. Annora is Hetero's finished-dosage (formulations) arm, manufacturing generic oral solid and liquid dosages — tablets, capsules, pellets, liquid orals, suppositories and dry-powder syrups — plus anti-retroviral, anti-epileptic, anti-hypertensive and anti-depressant products. CARE Ratings reported it had filed 75 ANDAs by early 2024 (40 approved), with a US FDA-approved plant. It derives the large majority of revenue from sales to group entities (Hetero Labs and Camber Pharmaceuticals).
Litigation posture. Annora is an operating company defending against originator Hatch-Waxman suits, not an NPE. The tracked data show 0 cases as plaintiff and 1 as defendant, consistent with a generic manufacturer responding to Paragraph IV/ANDA infringement complaints. Its suits (including the tracked one) sit in the District of Delaware, the dominant U.S. venue for ANDA litigation.
Notable case. The tracked matter is Merck Sharp & Dohme Corp. v. Annora Pharma Private Ltd. (D. Del.), an ANDA dispute. Public records also show other Paragraph IV suits against Annora and affiliated Hetero entities (e.g., Rigel, Celgene, Boehringer Ingelheim). Case outcomes are not assessed here.
Settled by consent judgment; unless specifically authorized under the settlement agreement, Annora is enjoined from infringing the patent-in-suit.