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Flibanserin - Generic Drug Details

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

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 patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for flibanserin

International Patents:	80
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Clinical Trials:	16
Patent Applications:	397
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	flibanserin at DailyMed

Pharmacology for flibanserin

Mechanism of Action

P-Glycoprotein Inhibitors

Synonyms for flibanserin

1-(2-(4-(3-(trifluoromethyl)phenyl)piperazin-1-yl)ethyl)-1H-benzo[d]imidazol-2(3H)-one

1-(2-(4-(3-Trifluoromethylphenyl)piperazin-1-yl)ethyl)benzimidazol(1H)-2-one

1-(2-(4-(alpha,alpha,alpha-Trifluoro-m-tolyl)-1-piperazinyl)ethyl)-2-benzimidazolinone

1-(2-(4-alpha,alpha,alpha-Trifluoro-m-tolyl)-1-(piperazinyl)ethyl)-2-benzimidazolinone

1-(2-(4-alpha,alpha,alpha-Trifluoro-m-tolyl)-1-piperazinyl)ethyl)-2-benzimidazolinone

1-(2-{4-[3-(trifluoromethyl)phenyl]piperazin-1-yl}ethyl)-1,3-dihydro-2H-benzimidazol-2-one

1,3-Dihydro-1-(2-(4-(3-(trifluoromethyl)phenyl)-1-piperazinyl)ethyl)-2H-benzimidazol-2-one

167933-07-5

2H-Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]-

2H-Benzimidazol-2-one,1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]-

3-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]-1H-benzimidazol-2-one

3-[2-[4-[3-(trifluoromethyl)phenyl]piperazin-1-yl]ethyl]-1H-benzimidazol-2-one

37JK4STR6Z

933F075

A810922

AC1OCF7H

Addyi

Addyi (TN)

AK326155

AKOS005146139

AM84577

API0006409

AT-16920

Bimt 17

BIMT 17 BS

Bimt-17

BIMT-17-BS

CHEBI:90865

CHEMBL231068

CS-4671

D02577

D0S9CB

DB04908

Ectris

Female Viagra (Street Name)

Female Viagra [Street Name]

Flibanserin (USAN/INN)

Flibanserin [USAN:INN]

FT-0659246

Girosa

Girosa (proposed trade name)

GTPL8182

HSDB 8278

HY-A0095

KS-00000293

L001463

MFCD00918402

MolPort-006-170-023

SC-28449

SCHEMBL247579

UNII-37JK4STR6Z

ZINC52716421

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
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes			Y	Y
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes

Non-Orange Book US Patents for flibanserin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,183,410	Stable polymorph of flibanserin
9,782,403	Treating sexual desire disorders with flibanserin

International Patents for flibanserin

Country	Document Number	Estimated Expiration
Slovenia	1446122
Spain	2266632
Ecuador	SP045069
Serbia	50742