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Last Updated: June 23, 2024

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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
Drug patent expirations by year for ADDYI
Drug Prices for ADDYI

See drug prices for ADDYI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ADDYI
Generic Entry Date for ADDYI*:
Constraining patent/regulatory exclusivity:
NDA:
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 ActionP-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)

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

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.

Country Patent Number Title Estimated Expiration
China 1571670 ⤷  Sign Up
European Patent Office 1446122 UTILISATION DE LA FLIBANSERINE DANS LE TRAITEMENT DE TROUBLES DU DESIR SEXUEL (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DESIRE DISORDERS) ⤷  Sign Up
Eurasian Patent Organization 007274 ПРИМЕНЕНИЕ ФЛИБАНСЕРИНА ДЛЯ ЛЕЧЕНИЯ ПОЛОВЫХ РАССТРОЙСТВ (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS) ⤷  Sign Up
Spain 2266632 ⤷  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
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.