Last Updated: July 4, 2026

FINGOLIMOD Drug Patent Profile

Name: FINGOLIMOD Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Fingolimod, and when can generic versions of Fingolimod launch?

Fingolimod is a drug marketed by Accord Hlthcare, Alembic, 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, and Zydus Pharms. and is included in nineteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fingolimod

A generic version of FINGOLIMOD was approved as fingolimod hydrochloride by BIOCON LTD on December 4^th, 2019.

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Summary for FINGOLIMOD

US Patents:	0
Applicants:	18
NDAs:	19
Drug Prices:	Drug price information for FINGOLIMOD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINGOLIMOD
DailyMed Link:	FINGOLIMOD at DailyMed

Drug patent expirations by year for FINGOLIMOD

Recent Clinical Trials for FINGOLIMOD

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

Sponsor	Phase
TG Therapeutics, Inc.	PHASE2
Texas Tech University Health Sciences Center	PHASE2
Laboratory Corporation of America	PHASE2

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US Patents and Regulatory Information for FINGOLIMOD

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207991-001	Oct 28, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Usa	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208008-001	Jul 2, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bionpharma	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	210252-001	May 24, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apotex	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207993-001	Dec 18, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hec Pharm Co Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207939-001	Nov 10, 2021	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Rx	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207971-001	Jun 29, 2020		DISCN	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

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.