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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 NDA: 022526

Tradename:
ADDYI
Applicant:
Sprout Pharms
Ingredient:
flibanserin
Patents:4

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 58604-214-03 1 BOTTLE in 1 CARTON (58604-214-03) > 30 TABLET, FILM COATED in 1 BOTTLE
ADDYI
flibanserin
TABLET;ORAL 022526 NDA Sprout Pharmaceuticals, Inc. 58604-214 58604-214-30 1 BOTTLE in 1 CARTON (58604-214-30) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 18, 2015TE:RLD:Yes
Patent:7,420,057Patent Expiration:Aug 1, 2022Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 18, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,151,103Patent 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)


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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