FESOTERODINE FUMARATE Drug Patent Profile
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Which patents cover Fesoterodine Fumarate, and what generic alternatives are available?
Fesoterodine Fumarate is a drug 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, and Zydus Pharms. and is included in eleven NDAs.
The generic ingredient in FESOTERODINE FUMARATE is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fesoterodine Fumarate
A generic version of FESOTERODINE FUMARATE was approved as fesoterodine fumarate by ALKEM LABS LTD on December 10th, 2015.
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Summary for FESOTERODINE FUMARATE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 10 |
| Patent Applications: | 142 |
| 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 |
|---|---|
| University of North Carolina, Chapel Hill | Phase 3 |
| National Institute on Aging (NIA) | Phase 3 |
| Mayo Clinic | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for FESOTERODINE FUMARATE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205012-001 | Jan 4, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204975-002 | Aug 13, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204827-001 | 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 |
