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Fesoterodine fumarate - Generic Drug Details

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What are the generic drug sources for fesoterodine fumarate and what is the scope of patent protection?

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 four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fesoterodine fumarate has seventy-eight patent family members in twenty-nine 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:	78
US Patents:	4
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	15
Suppliers / Packagers:	5
Bulk Api Vendors:	54
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

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.

Paragraph IV (Patent) Challenges for FESOTERODINE FUMARATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TOVIAZ	TABLET, EXTENDED RELEASE;ORAL	fesoterodine fumarate	022030	2012-10-31

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
Zydus Pharms	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204946-002	Oct 3, 2017	AB	RX	No	No
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No			Y
Alkem Labs Ltd	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827-001	Dec 10, 2015		DISCN	No	No
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No				Y
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

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	022030-002	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	022030-002	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
Japan	2011148824
Iceland	8382
Ukraine	73324
Brazil	PI0015610
World Intellectual Property Organization (WIPO)	0135957
Germany	50009239

Supplementary Protection Certificates for fesoterodine fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1230209	PA2007008	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912	SZ 47/2007	Austria		PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
1230209	PA2007008,C1230209	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.
1481964	C 2007 098	Romania		PRODUCT NAME: FUMARATACID DE FESOTERODINA IN FORMA CRISTALINA 2[(1R)-3-(DIIZOPROPILAMINO)-1-FENILPROPIL]-4-(HIDROXIMETIL)FENILIZOBUTIRIC INFORMA CRISTALINA - FUMARAT ACID DE FESOTERODINA IN FORMA CRISTALINA; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/386/001, RO EU/1/07/386/002, RO EU/1/07/386/003, RO EU/1/07/386/004, RO EU/1/07/386/005, RO EU/1/07/386/006, RO EU/1/07/386/007, RO EU/1/07/386/008, RO EU/1/07/386/009, RO EU/1/07/386/010; DATE OF NATIONAL AUTHORISATION: 20070420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/386/001, EU/1/07/386/002, EU/1/07/386/003, EU/1/07/386/004, EU/1/07/386/005, EU/1/07/386/006, EU/1/07/386/007, EU/1/07/386/0 [...]