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Last Updated: April 25, 2024

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 is one patent 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:	1
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022526

Generic Entry Date for 022526^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022526

Mechanism of Action	P-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	58604-214-30	1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 18, 2015	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	May 9, 2028	Product 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)

Expired US Patents for NDA 022526

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	⤷ Try a Trial	⤷ Try a Trial
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	⤷ Try a Trial	⤷ Try a Trial
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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