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Last Updated: April 24, 2024

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, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in nineteen 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 forty-six patent family members in fifty countries.

There are twenty drug master file entries for fingolimod hydrochloride. Nineteen suppliers are listed for this compound.

Recent Clinical Trials for fingolimod hydrochloride

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

SponsorPhase
The Methodist Hospital Research InstitutePhase 2
General Hospital of Shenyang Military RegionPhase 4
Hoffmann-La RochePhase 3

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 Strength NDA ANDAs Submitted Submissiondate
GILENYA Capsules fingolimod hydrochloride 0.25 mg 022527 1 2018-07-19
GILENYA Capsules fingolimod hydrochloride 0.5 mg 022527 19 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
Mylan FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208005-001 Jan 19, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207971-001 Jun 29, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208003-001 Sep 7, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alkem Labs Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208004-001 Dec 30, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 022527-001 Sep 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fingolimod hydrochloride

Country Patent Number Title Estimated Expiration
Brazil 112013024430 formulações compreendendo 2-amino-2-[2-(4-octilfenil)etil]propano-1,3-diol ⤷  Try a Trial
Japan 2014509652 ⤷  Try a Trial
South Africa 201306636 FORMULAIONS COMPRISING 2 -AMINO- 2-[2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL ⤷  Try a Trial
Austria 414508 ⤷  Try a Trial
Norway 2011016 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fingolimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 107 5008-2011 Slovakia ⤷  Try a Trial FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 20110317
1613288 C20110013 00043 Estonia ⤷  Try a Trial PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288 SPC/GB11/045 United Kingdom ⤷  Try a Trial PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1613288 C 2011 005 Romania ⤷  Try a 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
0627406 SPC/GB11/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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