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Last Updated: January 17, 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
Wake Forest University Health SciencesEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1

See all fingolimod clinical trials

Recent Litigation for fingolimod

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc.2018-07-16
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2018-07-13
Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd.2018-07-13

See all fingolimod litigation

PTAB Litigation
PetitionerDate
Sun Pharmaceutical Industries, Ltd.2017-08-16
Actavis Elizabeth LLC2017-08-15
Argentum Pharmaceuticals LLC2017-06-09

See all fingolimod litigation

Generic filers with tentative approvals for FINGOLIMOD
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5MGCAPSULE;ORAL
  Start Trial  Start Trial0.5MGCAPSULE;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
Biocon Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207979-001 Dec 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   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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