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Generated: July 23, 2017
What are the generic sources for fesoterodine fumarate and what is the scope of fesoterodine fumarate freedom to operate?
Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Alkem Labs Ltd, and Pfizer, and is included in three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 9 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 13 |
| Suppliers / Packagers: see list | 5 |
| Bulk Api Vendors: see list | 29 |
| Clinical Trials: see list | 585 |
| Patent Applications: see list | 15 |
| Drug Prices: | see low prices |
| DailyMed Link: | fesoterodine fumarate at DailyMed |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 4MG | TABLET, EXTENDED RELEASE;ORAL |
| ► Subscribe | ► Subscribe | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| ► Subscribe | ► Subscribe | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| 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 | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | 8,501,723 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | 7,384,980 | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | 8,088,398 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | 8,501,723 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Alkem Labs Ltd | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204827-002 | Dec 10, 2015 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,364,541 | Pharmaceutical compositions comprising Fesoterodine | ► Subscribe | |||||||||||||||||||||||||||
| 7,230,030 | Derivatives of 3,3-diphenylpropylamines | ► Subscribe | |||||||||||||||||||||||||||
| 6,713,464 | Derivatives of 3,3-diphenylpropylamines | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 3929702 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2236032 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2003519079 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 20021343 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 220056 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1077912/01 | Switzerland | ► Subscribe | PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008 | ||||||||||||||||||||||||||
| C/GB07/053 | United Kingdom | ► Subscribe | 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. | ||||||||||||||||||||||||||
| C037/2007 | Ireland | ► Subscribe | SPC037/2007: 20080507, EXPIRES: 20220419 | ||||||||||||||||||||||||||
| 365 | Luxembourg | ► Subscribe | 91365, EXPIRES: 20220420 | ||||||||||||||||||||||||||
| C0050 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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