Last Updated: July 27, 2026

Fingolimod - Generic Drug Details

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Summary for fingolimod

International Patents:	137
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	52
Patent Applications:	2,547
Drug Prices:	Drug price trends for fingolimod
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fingolimod
What excipients (inactive ingredients) are in fingolimod?	fingolimod excipients list
DailyMed Link:	fingolimod at DailyMed

Drug Prices for fingolimod

See drug prices for fingolimod

Recent Clinical Trials for fingolimod

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

Sponsor	Phase
TG Therapeutics, Inc.	PHASE2
Novartis	PHASE2
Arizona State University	PHASE2

See all fingolimod clinical trials

Generic filers with tentative approvals for FINGOLIMOD

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	EQ 0.5MG BASE	CAPSULE;ORAL
⤷ Start Trial	⤷ Start Trial	EQ 0.5MG BASE	CAPSULE;ORAL
⤷ Start Trial	⤷ Start Trial	0.5MG	CAPSULE;ORAL

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

US Patents and Regulatory Information for fingolimod

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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
Ezra Ventures	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207945-001	Dec 6, 2023	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
Teva Pharms Usa	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	212152-001	Nov 12, 2021		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	9,925,138	⤷ Start Trial	Y			⤷ Start Trial
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	10,925,829	⤷ Start Trial	Y			⤷ 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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