FESOTERODINE FUMARATE - Generic Drug Details
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What are the generic sources for fesoterodine fumarate and what is the scope of patent protection?
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 |
Generic filers with tentative approvals for FESOTERODINE FUMARATE
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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd V | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204792-002 | Jan 9, 2024 | 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 | |||
| Dr Reddys | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204975-001 | Aug 13, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Zydus Pharms | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204946-002 | Oct 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Fl Inc | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204868-001 | Jan 4, 2023 | DISCN | 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
| 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 | ⤷ 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
