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 Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Zydus Pharms, and Pfizer, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for fesoterodine fumarate

US Patents:	3
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	10
Patent Applications:	267
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fesoterodine fumarate
What excipients (inactive ingredients) are in fesoterodine fumarate?	fesoterodine fumarate excipients list
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)	Phase 3
University of North Carolina, Chapel Hill	Phase 3
Mayo Clinic	Phase 4

See all fesoterodine fumarate clinical trials

Generic filers with tentative approvals for FESOTERODINE FUMARATE

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

Anatomical Therapeutic Chemical (ATC) Classes for fesoterodine fumarate

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for FESOTERODINE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOVIAZ	Extended-release Tablets	fesoterodine fumarate	4 mg and 8 mg	022030	16	2012-10-31

US Patents and Regulatory Information for fesoterodine fumarate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	205002-002	Jan 4, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	205002-001	Jan 4, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204973-002	Jan 4, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827-002	Dec 10, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for fesoterodine fumarate

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

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