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Last Updated: February 25, 2021

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GILENYA Drug Profile

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Which patents cover Gilenya, and what generic alternatives are available?

Gilenya is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-three patent family members in fifty countries.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

Drug patent expirations by year for GILENYA
Drug Prices for GILENYA

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Recent Clinical Trials for GILENYA

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

SponsorPhase
Hikma Pharmaceuticals LLCPhase 1
Genuine Research Center, EgyptPhase 1
Wake Forest University Health SciencesEarly Phase 1

See all GILENYA clinical trials

Paragraph IV (Patent) Challenges for GILENYA
Tradename Dosage Ingredient NDA Submissiondate
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-19
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-18
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2014-09-22

US Patents and Regulatory Information for GILENYA

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   Start Trial   Start Trial Y   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   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
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes 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

Expired US Patents for GILENYA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 PA2011010 Lithuania   Start Trial PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011 03 17 EU/1/11/677/002, 2011 03 17 EU/1/11/677/003, 2011 03 17 EU/1/11/677/004 20110317
0627406 C00627406/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1613288 C 2011 005 Romania   Start Trial PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1613288 C01613288/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1613288 2011C/030 Belgium   Start Trial PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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