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 Biocon Ltd, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Strides Pharma, Sun Pharm, and Novartis, and is included in seven 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 eighteen patent family members in fifty countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. Two suppliers are listed for this compound.

Summary for fingolimod hydrochloride

International Patents:	218
US Patents:	4
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	21
Suppliers / Packagers:	2
Bulk Api Vendors:	115
Clinical Trials:	60
Patent Applications:	155
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
First Affiliated Hospital of Fujian Medical University	Phase 2
Wake Forest University Health Sciences	Early Phase 1
Mayo Clinic	Early Phase 1

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	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
Sun Pharm	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208014-001	Dec 4, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Biocon Ltd	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207979-001	Dec 4, 2019		DISCN	No	No	Start Trial	Start Trial				Start Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018		RX	Yes	No	Start Trial	Start Trial				Start 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	022527-002	May 11, 2018	Start Trial	Start Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	Start Trial	Start Trial
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	Start Trial	Start 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	Estimated Expiration
Australia	2007264031	Start Trial
Canada	2831600	Start Trial
South Korea	20120083442	Start Trial
>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	CR 2011 00023	Denmark	Start Trial	PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
1613288	C300497	Netherlands	Start Trial	PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406	C300488	Netherlands	Start 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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