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Last Updated: March 5, 2021

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Fingolimod hydrochloride - Generic Drug Details

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What are the generic sources for fingolimod hydrochloride and what is the scope of patent protection?

Fingolimod hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Biocon Ltd, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Strides Pharma, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in twelve NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod hydrochloride has two hundred and twenty-four patent family members in fifty countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for fingolimod hydrochloride

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

SponsorPhase
The Affiliated Hospital of Xuzhou Medical UniversityN/A
Ning Wang, MD., PhD.Phase 2
Tammie L. S. Benzinger, MD, PhDPhase 1

See all fingolimod hydrochloride clinical trials

Pharmacology for fingolimod hydrochloride
Medical Subject Heading (MeSH) Categories for fingolimod hydrochloride
Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE
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 fingolimod hydrochloride

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
Hetero Labs Ltd V FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207933-001 May 18, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207985-001 Jun 18, 2020 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

Expired US Patents for fingolimod hydrochloride

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 fingolimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 122011100047 Germany   Start Trial PRODUCT NAME: FINGOLIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON; NAT. REGISTRATION NO/DATE: FIRST REGISTRATION: EU EU/1/11/677/001-004 20110317EU/1/11/677/001 EU/1/11/677/002 EU/1/11/677/003 EU/1/11/677/004 20110317
1613288 28/2011 Austria   Start Trial PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317
1613288 C20110013 00043 Estonia   Start Trial PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
0627406 2011020 Ireland   Start Trial PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Dow
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Merck
Medtronic

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