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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Merck
Cipla
Fuji
Medtronic
Fish and Richardson
US Army
Express Scripts

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022526

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NDA 022526 describes ADDYI, which is a drug marketed by Sprout Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ADDYI profile page.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.
Summary for 022526
Tradename:ADDYI
Applicant:Sprout Pharms
Ingredient:flibanserin
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022526
Mechanism of ActionP-Glycoprotein Inhibitors
Suppliers and Packaging for NDA: 022526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADDYI flibanserin TABLET;ORAL 022526 NDA Sprout Pharmaceuticals, Inc. 58604-214 N 58604-214-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 18, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 18, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:May 9, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
Patent:➤ Sign UpPatent Expiration:Aug 1, 2022Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Army
Teva
Dow
Healthtrust
Chubb
Julphar
Deloitte
McKinsey

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