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ADDYI Drug Profile

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Which patents cover Addyi, and what generic alternatives are available?

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

This drug has eighty patent family members in thirty-one countries.

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

Summary for ADDYI

International Patents:	80
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	40
Patent Applications:	233
Formulation / Manufacturing:	see details
DailyMed Link:	ADDYI at DailyMed

Generic Entry Opportunity Date for ADDYI

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

Synonyms for ADDYI

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 (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

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 ADDYI

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

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Non-Orange Book US Patents for ADDYI

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
9,782,403	Treating sexual desire disorders with flibanserin
7,183,410	Stable polymorph of flibanserin

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International Patents for ADDYI

Country	Document Number	Estimated Expiration
Brazil	0213358
Ecuador	SP044966
Eurasian Patent Organization	006400
Norway	20041588