TOVIAZ Drug Patent Profile
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When do Toviaz patents expire, and when can generic versions of Toviaz launch?
Toviaz is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in TOVIAZ is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Toviaz
A generic version of TOVIAZ was approved as fesoterodine fumarate by ALKEM LABS LTD on December 10th, 2015.
Summary for TOVIAZ
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 25 |
Patent Applications: | 165 |
Drug Prices: | Drug price information for TOVIAZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOVIAZ |
What excipients (inactive ingredients) are in TOVIAZ? | TOVIAZ excipients list |
DailyMed Link: | TOVIAZ at DailyMed |
Recent Clinical Trials for TOVIAZ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sir Mortimer B. Davis - Jewish General Hospital | Phase 4 |
University of Alberta | Phase 2 |
International Collaboration On Repair Discoveries (ICORD) | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for TOVIAZ
Paragraph IV (Patent) Challenges for TOVIAZ
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 TOVIAZ
TOVIAZ is protected by three US patents and two FDA Regulatory Exclusivities.
Patents protecting TOVIAZ
Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions comprising fesoterodine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting TOVIAZ
TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 TOVIAZ
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOVIAZ
See the table below for patents covering TOVIAZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9958478 | ⤷ Try a Trial | |
Japan | 2007137895 | STABLE SALT OF NEW DERIVATIVE OF 3, 3-DIPHENYL PROPYLAMINES | ⤷ Try a Trial |
Poland | 195581 | ⤷ Try a Trial | |
Germany | 19955190 | ⤷ Try a Trial | |
Germany | 122007000065 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOVIAZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1481964 | C 2007 098 | Romania | ⤷ Try a Trial | 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 | SPC037/2007 | Ireland | ⤷ Try a Trial | SPC037/2007: 20080507, EXPIRES: 20220419 |
1077912 | C01077912/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008 |
1077912 | 07C0050 | France | ⤷ Try a Trial | 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 | SPC/GB07/053 | United Kingdom | ⤷ Try a Trial | 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. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |