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Last Updated: November 27, 2021

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Fingolimod hydrochloride - Generic Drug Details

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What are the generic drug sources for fingolimod hydrochloride and what is the scope of freedom to operate?

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, Hetero Labs Ltd V, Mylan, Strides Pharma, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in thirteen 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-one patent family members in fifty countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for fingolimod hydrochloride

International Patents:	231
US Patents:	4
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	70
Patent Applications:	167
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fingolimod hydrochloride
DailyMed Link:	fingolimod hydrochloride at DailyMed

Recent Clinical Trials for fingolimod hydrochloride

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

Sponsor	Phase
The Affiliated Hospital of Xuzhou Medical University	N/A
Ning Wang, MD., PhD.	Phase 2
Tammie L. S. Benzinger, MD, PhD

See all fingolimod hydrochloride clinical trials

Generic filers with tentative approvals for FINGOLIMOD HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try it Free	⤷ Try it Free	EQ 0.5MG BASE	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.

Pharmacology for fingolimod hydrochloride

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Medical Subject Heading (MeSH) Categories for fingolimod hydrochloride

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for fingolimod hydrochloride

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
GILENYA	CAPSULE;ORAL	fingolimod hydrochloride	022527	2018-07-19
GILENYA	CAPSULE;ORAL	fingolimod hydrochloride	022527	2018-07-18
GILENYA	CAPSULE;ORAL	fingolimod hydrochloride	022527	2014-09-22

US Patents and Regulatory Information for fingolimod hydrochloride

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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
Hetero Labs Ltd V	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207933-001	May 18, 2020	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Strides Pharma	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207971-001	Jun 29, 2020		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Dr Reddys	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208000-001	Mar 5, 2021	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Biocon Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207979-001	Dec 4, 2019		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Mylan	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208005-001	Jan 19, 2021		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018	⤷ Try it Free	⤷ Try it Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	⤷ Try it Free	⤷ Try it Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fingolimod hydrochloride

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Country	Patent Number	Estimated Expiration
Russian Federation	2569732	⤷ Try it Free
Chile	2011000450	⤷ Try it Free
European Patent Office	3143990	⤷ Try it Free
Slovenia	3143990	⤷ Try it Free
Italy	MI20040682	⤷ Try it Free
Hungary	S1100016	⤷ Try it Free
Japan	2021035955	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for fingolimod hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C20110013 00043	Estonia	⤷ Try it Free	PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288	CA 2011 00023	Denmark	⤷ Try it Free
1613288	399	Finland	⤷ Try it Free
1613288	2011/027	Ireland	⤷ Try it Free	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
0627406	2011020	Ireland	⤷ Try it Free	PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011
0627406	1190015-6	Sweden	⤷ Try it Free	PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288	PA2011010	Lithuania	⤷ Try it Free	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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. 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.