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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212640

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NDA 212640 describes EXSERVAN, which is a drug marketed by Aquestive Therap and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the EXSERVAN profile page.

The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 212640
Tradename:EXSERVAN
Applicant:Aquestive Therap
Ingredient:riluzole
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 212640
Medical Subject Heading (MeSH) Categories for 212640
Suppliers and Packaging for NDA: 212640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXSERVAN riluzole FILM;ORAL 212640 NDA Aquestive Therapeutics 10094-350 10094-350-60 50 POUCH in 1 CARTON (10094-350-60) > 1 FILM in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength50MG
Approval Date:Nov 22, 2019TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 20, 2024Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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Dow

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