Gilead Sciences Inc. (GILD) said it was notified that Sigmapharm Laboratories LLC has submitted an abbreviated new drug application to the FDA, requesting permission to manufacture and market a generic version of Hepsera.
In a Paragraph IV Certification notice letter, Sigmapharm alleges that two patents associated with Hepsera owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Sigmapharm's manufacture, use or sale of the product described in its ANDA submission.
Gilead said it is currently reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Sigmapharm.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.