Flibanserin - Generic Drug Details

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What are the generic drug sources for flibanserin and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for flibanserin

International Patents:	42
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	19
Patent Applications:	556
What excipients (inactive ingredients) are in flibanserin?	flibanserin excipients list
DailyMed Link:	flibanserin at DailyMed

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

Generic Entry Date for flibanserin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for flibanserin

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

Sponsor	Phase
Andrew McDonald	Phase 2
Sprout Pharmaceuticals, Inc	Phase 2
Mohit Khera	Phase 2

See all flibanserin clinical trials

Pharmacology for flibanserin

Mechanism of Action	P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for flibanserin

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for flibanserin

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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 flibanserin

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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 flibanserin

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Country	Patent Number	Title	Estimated Expiration
Denmark	1446122		⤷ Sign Up
Eurasian Patent Organization	007274	ПРИМЕНЕНИЕ ФЛИБАНСЕРИНА ДЛЯ ЛЕЧЕНИЯ ПОЛОВЫХ РАССТРОЙСТВ (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS)	⤷ Sign Up
South Korea	20040047931		⤷ Sign Up
Mexico	PA04003666	USO DE FLIBANSERINA PARA TRATAMIENTO DE TRASTORNOS SEXUALES. (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS.)	⤷ Sign Up
Croatia	P20040352	PRIMJENA FLIBANSERINA U LIJEČENJU SEKSUALNE DISFUNKCIJE (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS)	⤷ Sign Up
New Zealand	532079	Use of flibanserin in the treatment of sexual disorders and desire	⤷ Sign Up
South Africa	200401366	USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISODERS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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