Granules India Limited Files Paragraph IV Certification for Ruxolitinib Tablets
What happened
Granules India Limited filed an ANDA and Paragraph IV certification with the FDA on October 7, 2026, concerning Ruxolitinib Extended-Release Tablets. The company provided required notice to relevant parties. Granules India Limited stated that, subject to FDA review, it believes it is eligible for first-to-file status.
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Why it matters
The filing relates to the generic equivalent of a brand product. If the FDA confirms first-to-file status, the company may gain 180 days of generic drug exclusivity under U.S. law. This action signals increased market competition in the pharmaceutical sector.
A company previously submitted study data supporting a PMA submission to the FDA.
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Who's involved
- Granules India LimitedSubmitted the regulatory applications (ANDA/Paragraph IV) to the FDA.
- FDAThe regulatory agency reviewing the drug application.
- Eli Lilly and CompanyA pharmaceutical company whose market exclusivity may be threatened by generic entry.
- AlkermesA company actively developing generic equivalents of brand products.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Eli Lilly and CompanySpeculative
Eli Lilly and Company might face reduced revenue and market exclusivity due to potential generic entry.
How it developed
Newest first. Tap a step to see who reported it.- USFDA conducted an inspection at Granules facility on November 1, 2026.Sub-event
Granules India Limited files ANDA and Paragraph IV certification with the FDA.1 source
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The entities involved
- FDA
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Granules India Limited
Indian pharmaceutical company
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