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, Dr Reddys, 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 fourteen drug master file entries for fesoterodine fumarate. Eight suppliers are listed for this compound. There are three 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: | 14 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 10 |
| Patent Applications: | 416 |
| 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 |
|---|---|
| University of North Carolina, Chapel Hill | Phase 3 |
| National Institute on Aging (NIA) | Phase 3 |
| Mayo Clinic | Phase 4 |
Generic filers with tentative approvals for FESOTERODINE FUMARATE
| Applicant | Application No. | Strength | Dosage Form |
| See Plans and Pricing | See Plans and Pricing | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| See Plans and Pricing | See Plans and Pricing | 4MG | TABLET, EXTENDED RELEASE;ORAL |
| See Plans and Pricing | See Plans and Pricing | 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 | 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
Expired US Patents for fesoterodine fumarate
International Patents for fesoterodine fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1230209 | SELS STABLES DE NOUVEAUX DERIVES DE 3,3-DIPHENYLPROPYLAMINES (STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES) | See Plans and Pricing |
| Japan | 2010180243 | STABLE SALT OF NOVEL DERIVATIVE OF 3,3-DIPHENYLPROPYLAMINES | See Plans and Pricing |
| Israel | 149567 | STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES | See Plans and Pricing |
| Japan | 2007137895 | STABLE SALT OF NEW DERIVATIVE OF 3, 3-DIPHENYL PROPYLAMINES | See Plans and Pricing |
| China | 1390194 | See Plans and Pricing | |
| Hong Kong | 1095736 | See Plans and Pricing | |
| Denmark | 1690536 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fesoterodine fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1481964 | C 2007 098 | Romania | See Plans and Pricing | 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 [...] |
| 1077912 | SPC/GB07/053 | United Kingdom | See Plans and Pricing | 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. |
| 1230209 | PA2007008 | Lithuania | See Plans and Pricing | PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420 |
| 1077912 | 07C0050 | France | See Plans and Pricing | 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 |
| 1077912 | SZ 47/2007 | Austria | See Plans and Pricing | PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE |
| 1230209 | PA2007008,C1230209 | Lithuania | See Plans and Pricing | PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
