Part of Hetero Drugs Ltd.
Clinical Trials
6
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
2
33.3%
Recruiting
4
66.7%
No approval data available
- Catalyst Pharmaceuticals and SERB S.A. have settled patent litigation with Hetero Labs Ltd., preventing generic competition for FIRDAPSE until January 2035. - The settlement resolves all pending FIRDAPSE patent litigation, following previous agreements with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited. - FIRDAPSE, approved for Lambert-Eaton Myasthenic Syndrome, continues to drive Catalyst's record financial performance with Q2 2025 revenues reaching $146.6 million, up 19.4% year-over-year. - Analysts maintain unanimous Strong Buy ratings with an average price target of $34, representing over 60% upside potential from current trading levels around $21.
- A Delaware federal judge dismissed Ingenus Pharmaceuticals' patent infringement lawsuit against Hetero Labs over generic cyclophosphamide, ruling the company cannot pursue claims on a previously invalidated patent. - The court found that Ingenus already had a fair opportunity to defend US Patent No. 10,993,952's validity in a separate Illinois case against Nexus Pharmaceuticals and lost. - Judge Jennifer L. Hall granted summary judgment in favor of Hetero Labs, effectively barring Ingenus from relitigating the patent's validity in the Delaware case. - The ruling highlights the legal principle that prevents patent holders from repeatedly challenging generic drug makers over patents that have already been deemed invalid in prior litigation.
