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Last Updated: May 10, 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. Nineteen suppliers are listed for this compound.

Summary for FINGOLIMOD HYDROCHLORIDE

International Patents:	246
US Patents:	4
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	74
Patent Applications:	829
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINGOLIMOD HYDROCHLORIDE
What excipients (inactive ingredients) are in FINGOLIMOD HYDROCHLORIDE?	FINGOLIMOD HYDROCHLORIDE excipients list
DailyMed Link:	FINGOLIMOD HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FINGOLIMOD HYDROCHLORIDE

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

Sponsor	Phase
The Methodist Hospital Research Institute	Phase 2
General Hospital of Shenyang Military Region	Phase 4
PPD	Phase 3

See all FINGOLIMOD HYDROCHLORIDE clinical trials

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

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

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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
Apotex	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207993-001	Dec 18, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207971-001	Jun 29, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208004-001	Dec 30, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208000-001	Mar 5, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207985-001	Jun 18, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	022527-001	Sep 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018	⤷ Try a Trial	⤷ Try a Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FINGOLIMOD HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Iceland	2682		⤷ Try a Trial
South Africa	201201678	DOSAGE REGIMEN OF AN S1P RECEPTOR MODULATOR	⤷ Try a Trial
New Zealand	726133	Dosage regimen of an s1p receptor modulator	⤷ Try a Trial
Japan	2004307506	SOLID PHARMACEUTICAL COMPOSITION	⤷ Try a Trial
Slovenia	2694037		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0627406	11C0021	France	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
1613288	C20110013 00043	Estonia	⤷ Try a Trial	PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
0627406	SPC/GB11/026	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1613288	PA2011010	Lithuania	⤷ Try a Trial	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
1613288	91867	Luxembourg	⤷ Try a Trial	91867, EXPIRES: 20260317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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