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Last Updated: November 22, 2024

FINGOLIMOD HYDROCHLORIDE - Generic Drug Details


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What are the generic drug 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. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FINGOLIMOD HYDROCHLORIDE
Recent Clinical Trials for FINGOLIMOD HYDROCHLORIDE

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

SponsorPhase
Tang-Du HospitalPhase 1/Phase 2
The Methodist Hospital Research InstitutePhase 2
General Hospital of Shenyang Military RegionPhase 4

See all FINGOLIMOD HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FINGOLIMOD HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 0.5MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Hec Pharm Co Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207939-001 Nov 10, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208008-001 Jul 2, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207994-001 Oct 14, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FINGOLIMOD HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Denmark 3143990 ⤷  Sign Up
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) ⤷  Sign Up
Denmark 2316431 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 1190025-5 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321
1613288 CR 2011 00023 Denmark ⤷  Sign Up PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
1613288 2011/027 Ireland ⤷  Sign Up PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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