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Last Updated: May 20, 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
Prinston Inc	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208003-001	Sep 7, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207991-001	Oct 28, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207983-001	Feb 28, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd V	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207933-001	May 18, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208008-001	Jul 2, 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
Japan	5495467		⤷ Try a Trial
Ecuador	SP13012912	FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL	⤷ Try a Trial
New Zealand	598534	Dosage regimen of an s1p receptor modulator	⤷ Try a Trial
Japan	5543298		⤷ Try a Trial
Hong Kong	1190309	包含 -氨基- -辛基苯基乙基丙- -二醇的製劑 (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL]PROPANE - 1, 3 - DIOL 2--2-[2-(4-)]-13-)	⤷ Try a Trial
Morocco	33691	خطة علاج وحدات استقبالات s1p	⤷ Try a Trial
Australia	2013200356	S1P receptor modulators for treating multiple sclerosis	⤷ 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	SPC/GB11/045	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	2011C/030	Belgium	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
0627406	C300488	Netherlands	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406	1190015-6	Sweden	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288	PA2011010,C1613288	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	CR 2011 00023	Denmark	⤷ Try a Trial	PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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