Details for New Drug Application (NDA): 022527

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NDA 022527 describes GILENYA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the GILENYA profile page.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

Summary for 022527

Tradename:	GILENYA
Applicant:	Novartis
Ingredient:	fingolimod hydrochloride
Patents:	2

Pharmacology for NDA: 022527

Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Medical Subject Heading (MeSH) Categories for 022527

Immunosuppressive Agents

Suppliers and Packaging for NDA: 022527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527	NDA	Novartis Pharmaceuticals Corporation	0078-0607	0078-0607-15	30 CAPSULE in 1 BOTTLE (0078-0607-15)
GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527	NDA	Novartis Pharmaceuticals Corporation	0078-0965	0078-0965-89	7 CAPSULE in 1 CARTON (0078-0965-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Sep 21, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 25, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.25MG BASE
Approval Date:	May 11, 2018	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Sep 30, 2032	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022527

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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	⤷ Get Started Free	⤷ Get Started Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	⤷ Get Started Free	⤷ Get Started Free
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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