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Last Updated: August 17, 2022

FLIBANSERIN - Generic Drug Details


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What are the generic sources for flibanserin and what is the scope of patent protection?

Flibanserin is the generic ingredient in one branded drug marketed by Sprout Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Flibanserin has eighty-two patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for FLIBANSERIN
International Patents:82
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 66
Clinical Trials: 19
Patent Applications: 502
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in FLIBANSERIN?FLIBANSERIN excipients list
DailyMed Link:FLIBANSERIN at DailyMed
Recent Clinical Trials for FLIBANSERIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Andrew McDonaldPhase 2
Mohit KheraPhase 2
Sprout Pharmaceuticals, IncPhase 2

See all FLIBANSERIN clinical trials

Pharmacology for FLIBANSERIN
Mechanism of ActionP-Glycoprotein Inhibitors

US Patents and Regulatory Information for FLIBANSERIN

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

International Patents for FLIBANSERIN

Country Patent Number Title Estimated Expiration
China 102058597 See Plans and Pricing
Ukraine 76767 СТАБИЛЬНАЯ ПОЛИМОРФНАЯ МОДИФИКАЦИЯ ФЛИБАНСЕРИНА, СПОСОБ ЕЕ ПРОМЫШЛЕННОГО ПОЛУЧЕНИЯ И ЕЕ ИСПОЛЬЗОВАНИЕ ДЛЯ ПОЛУЧЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ;СТАБІЛЬНА ПОЛІМОРФНА МОДИФІКАЦІЯ ФЛІБАНСЕРИНУ, СПОСІБ ЇЇ ПРОМИСЛОВОГО ОДЕРЖАННЯ ТА ЇЇ ЗАСТОСУВАННЯ ДЛЯ ОДЕРЖАННЯ ЛІКАРСЬКИХ ЗАСОБІВ (stable polymorph modification of flibanserin, method for industrial production thereof and use thereof for preparing medicaments) See Plans and Pricing
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) See Plans and Pricing
Mexico PA04000913 COMPUESTO POLIMORFO ESTABLE DE FLIBANSERINA, PROCEDIMIENTO INDUSTRIAL PARA SU PREPARACION, Y USO DEL MISMO PARA PREPARAR MEDICAMENTOS. (STABLE POLYMORPH OF FLIBANSERIN, TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS.) See Plans and Pricing
Japan 2004537597 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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