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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 freedom to operate?

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Zydus Pharms, and Pfizer, and is included in five 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 fifteen drug master file entries for fesoterodine fumarate. Five 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:	5
NDAs:	5
Drug Master File Entries:	15
Suppliers / Packagers:	5
Bulk Api Vendors:	52
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

Recent Clinical Trials for fesoterodine fumarate

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

Sponsor	Phase
National Institute on Aging (NIA)	N/A
University of North Carolina, Chapel Hill	N/A
Mayo Clinic	Phase 4

See all fesoterodine fumarate clinical trials

Recent Litigation for fesoterodine fumarate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
PFIZER INC. v. DR. REDDYS LABORATORIES, LTD.	2015-11-19
Pfizer Inc. v. Dr. Reddy's Laboratories Ltd.	2015-11-18
Pfizer Inc. v. Mylan Pharmaceuticals Inc.	2015-01-23

See all fesoterodine fumarate litigation

PTAB Litigation

Petitioner	Date
Alembic Pharmaceuticals Limited	2016-08-22
Amerigen Pharmaceuticals Limited	2016-08-22
Torrent Pharmaceuticals Limited	2016-08-18

See all fesoterodine fumarate litigation

Generic filers with tentative approvals for FESOTERODINE FUMARATE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for fesoterodine fumarate

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

(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

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

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

SB19323

SCHEMBL1993632

SCHEMBL814971

SMR002544691

SPM 8272

SPM 907

SPM-8272

SPM-907

Toviaz

Toviaz (TN)

UNII-EOS72165S7

X5023

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	022030-001	Oct 31, 2008	AB	RX	Yes	No			Y	Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No				Y
Zydus Pharms	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	022030-001	Oct 31, 2008	AB	RX	Yes	No
Alkem Labs Ltd	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827-001	Dec 10, 2015		DISCN	No	No
Aurobindo Pharma Ltd	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	205007-002	Feb 17, 2017	AB	RX	No	No
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No			Y	Y

Expired US Patents for fesoterodine fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008

International Patents for fesoterodine fumarate

Country	Patent Number	Estimated Expiration
Czech Republic	302497
Czech Republic	296605
Brazil	9910406
Canada	2328920
Hungary	226490
European Patent Office	1077912
World Intellectual Property Organization (WIPO)	0135957

Supplementary Protection Certificates for fesoterodine fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	308	Finland
1230209	PA2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912	CA 2007 00046	Denmark		PRODUCT NAME: FESOTERODIN, FUMARAT
1077912	SPC037/2007	Ireland		SPC037/2007: 20080507, EXPIRES: 20220419
1230209	PA2007008	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912	SPC/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.
1077912	07C0050	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