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Last Updated: January 27, 2023

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 four 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. Fourteen 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:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022527
Medical Subject Heading (MeSH) Categories for 022527
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 0078-0607 0078-0607-89 7 CAPSULE in 1 CARTON (0078-0607-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 21, 2010TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Dec 25, 2027Product 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
Patent:See Plans and PricingPatent Expiration:Sep 29, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Dec 25, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022527

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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