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Last Updated: July 5, 2020

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Fingolimod - Generic Drug Details

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Recent Clinical Trials for fingolimod

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital of Fujian Medical UniversityPhase 2
Wake Forest University Health SciencesEarly Phase 1
Mayo ClinicEarly Phase 1

See all fingolimod clinical trials

Generic filers with tentative approvals for FINGOLIMOD
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5MGCAPSULE;ORAL
  Start Trial  Start TrialEQ 0.5MG BASECAPSULE;ORAL
  Start Trial  Start Trial0.5MGCAPSULE;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 022527-001 Sep 21, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sun Pharm FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208014-001 Dec 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hec Pharm Co Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207939-001 Dec 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>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 leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Medtronic
McKinsey
Merck

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