Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Mallinckrodt
AstraZeneca
Medtronic
Johnson and Johnson

Last Updated: December 7, 2022

Fingolimod hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Dr Reddys, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Strides Pharma, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in sixteen 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 thirty-five patent family members in fifty countries.

There are twenty drug master file entries for fingolimod hydrochloride. Fourteen 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
Sun Pharm FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208014-001 Dec 4, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208005-001 Jan 19, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Prinston Inc FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208003-001 Sep 7, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hec Pharm Co Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207939-001 Nov 10, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207991-001 Oct 28, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fingolimod hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008000419 See Plans and Pricing
Israel 228250 תכשירים המכילים 2-אמינו-2-[2-(4-אוקטילפניל)אתיל]פרופאנ-1,3-דיול (Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol) See Plans and Pricing
United Kingdom 2400318 Pharmaceutical composition comprising an S1P receptor agonist See Plans and Pricing
Ecuador SP056090 COMPOSICIÓN FARMACÉUTICA SÓLIDA QUE COMPRENDE UN AGONISTA DEL RECEPTOR DE S1P, Y UN ALCOHOL DE AZÚCAR See Plans and Pricing
New Zealand 542622 Solid pharmaceutical compositions comprising a S1P receptor agonist and a sugar alcohol See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fingolimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 2011C/030 Belgium See Plans and Pricing PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288 PA2011010,C1613288 Lithuania See Plans and Pricing 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
1613288 CA 2011 00023 Denmark See Plans and Pricing
1613288 91867 Luxembourg See Plans and Pricing 91867, EXPIRES: 20260317
1613288 C20110013 00043 Estonia See Plans and Pricing PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Boehringer Ingelheim
Mallinckrodt
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.