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Generated: August 18, 2019

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Fingolimod - Generic Drug Details

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Generic filers with tentative approvals for FINGOLIMOD
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.5MGCAPSULE;ORAL
➤ Sign Up➤ Sign Up0.5MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for fingolimod

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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Queensland Health
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Chinese Patent Office

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