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ADDYI Drug Patent Profile

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Which patents cover Addyi, and when can generic versions of Addyi launch?

Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in twenty-nine countries.

The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.

DrugPatentWatch^® Generic Entry Outlook for Addyi

Addyi was eligible for patent challenges on August 18, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 9, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ADDYI

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	556
Drug Prices:	Drug price information for ADDYI
What excipients (inactive ingredients) are in ADDYI?	ADDYI excipients list
DailyMed Link:	ADDYI at DailyMed

Drug patent expirations by year for ADDYI

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

Generic Entry Date for ADDYI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022526 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 ADDYI

Mechanism of Action	P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ADDYI

ADDYI is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADDYI is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ADDYI

Method of treating female hypoactive sexual desire disorder with flibanserin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ADDYI

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

International Patents for ADDYI

See the table below for patents covering ADDYI around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	122012029907	polimorfo a cristalino (forma a) da flibanserina 1, seu uso, processo para preparação técnica da flibanserina 1, e composições farmacêuticas	⤷ Sign Up
South Korea	20040023704		⤷ Sign Up
Canada	2450093	POLYMORPHE STABLE DE FLIBANSERINE, PROCEDE DE PREPARATION ASSOCIE ET UTILISATION DUDIT POLYMORPHE DANS LA PREPARATION DE MEDICAMENTS (STABLE POLYMORPH OF FLIBANSERIN, TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS)	⤷ Sign Up
Eurasian Patent Organization	200400481		⤷ Sign Up
China	1551879		⤷ Sign Up
Canada	2458067	UTILISATION DE LA FLIBANSERINE DANS LE TRAITEMENT DE TROUBLES SEXUELS (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS)	⤷ Sign Up
Slovenia	1414816		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration