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Fesoterodine fumarate - Generic Drug Details

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What are the generic sources for fesoterodine fumarate and what is the scope of fesoterodine fumarate freedom to operate?

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Zydus Pharms Usa Inc, and Pfizer, and is included in four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fesoterodine fumarate has one hundred and thirty-one patent family members in thirty-three countries.

There are fourteen drug master file entries for fesoterodine fumarate. Six suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for fesoterodine fumarate

International Patents:	131
US Patents:	8
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	14
Suppliers / Packagers:	6
Bulk Api Vendors:	45
Clinical Trials:	10
Patent Applications:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fesoterodine fumarate
DailyMed Link:	fesoterodine fumarate at DailyMed

Synonyms for fesoterodine fumarate

(E)-but-2-enedioic acid;[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate

(R)-Fesoterodine fumarate

[2-[(1R)-3-(diisopropylamino)-1-phenyl-propyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate; fumaric acid

2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate hydrogen (2E)-butenedioate (salt)

2-((1R)-3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate

286930-03-8

930F038

ABP000771

AC-3486

AK323629

AKOS005146248

AKOS015855886

AN-490

AT-36463

BC244477

BCP9000682

BCPP000231

C26H37NO3.C4H4O4

CHEMBL1201765

CS-0822

D08923

EOS72165S7

Fesoterodine fumarate - Toviaz

Fesoterodine fumarate (JAN/USP)

Fesoterodine fumarate [USAN:JAN]

Fesoterodine fumarate [USAN]

Fesoterodine fumarate, Toviaz

Fesoterodine fumarate/

Fesoterodine fumarate|286930-03-8

Fesoterodine maleate

fesoterodine; fumaric acid

Fesoterodinefumarate

Fesoterodinefumarate;(R)-Fesoterodine Fumarate;2-Methylpropanoic Acid 2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester (2E)-2-Butenedioate

HY-A0030

KB-51873

KS-1298

LS-184117

MFCD12756004

MLS003915638

MolPort-006-394-111

MWHXMIASLKXGBU-RNCYCKTQSA-N

PF-00695838

Propanoic acid, 2-methyl-, 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl ester, (2E)-2-butenedioate (1:1) (salt)

s2240

SCHEMBL1993632

SCHEMBL814971

SMR002544691

SPM 8272

SPM 907

SPM-8272

SPM-907

Toviaz

Toviaz (TN)

UNII-EOS72165S7

X5023

Tentative approvals for FESOTERODINE FUMARATE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET, EXTENDED RELEASE;ORAL
		8MG	TABLET, EXTENDED RELEASE;ORAL
		8MG	TABLET, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for fesoterodine fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes			Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes				Y
Zydus Pharms Usa Inc	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204946-001	Oct 3, 2017	AB	RX	No	No
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes			Y	Y
Alkem Labs Ltd	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827-002	Dec 10, 2015		DISCN	No	No

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Non-Orange Book US Patents for fesoterodine fumarate

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
6,713,464	Derivatives of 3,3-diphenylpropylamines
7,230,030	Derivatives of 3,3-diphenylpropylamines
9,364,541	Pharmaceutical compositions comprising Fesoterodine

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International Patents for fesoterodine fumarate

Country	Document Number	Estimated Expiration
European Patent Office	1254890
Japan	2010180242
Japan	3929702
New Zealand	507487
European Patent Office	1077912

Supplementary Protection Certificates for fesoterodine fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB07/053	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/053 GRANTED TO SCHWARZ PHARMA AG IN RESPECT OF THE PRODUCT FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6299 DATED 10 FEBRUARY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23 APRIL 2022.
365	Luxembourg		91365, EXPIRES: 20220420
2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
C0050	France		PRODUCT NAME: FESOTERODINE ET SES SELS AVEC DES ACIDES PHYSIOLOGIQUEMENT ACCEPTABLES NOTAMMENT L ACIDE FUMARIQUE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/386/001 DU 20070420; REGISTRATION NO/DATE AT EEC: EU/1/07/386/001 DU 20070420
8	Finland