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Last Updated: December 11, 2024

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
Tang-Du Hospital	Phase 1/Phase 2
The Methodist Hospital Research Institute	Phase 2
General Hospital of Shenyang Military Region	Phase 4

See all fingolimod clinical trials

Generic filers with tentative approvals for FINGOLIMOD

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 0.5MG BASE	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 0.5MG BASE	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	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
Bionpharma	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	210252-001	May 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-001	Dec 23, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208004-001	Dec 30, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962-002	Dec 9, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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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