Toviaz Patent Expiration

Toviaz is a drug owned by Pfizer Inc. It is protected by 12 US drug patents filed from 2013 to 2021. Out of these, 6 drug patents are active and 6 have expired. Toviaz's patents have been open to challenges since 18 December, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2027. Details of Toviaz's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7807715

(Pediatric)

Pharmaceutical compositions comprising fesoterodine
Dec, 2027

(3 years from now)

Active
US8501723

(Pediatric)

Pharmaceutical compositions comprising fesoterodine
Dec, 2027

(3 years from now)

Active
US8088398

(Pediatric)

Pharmaceutical compositions comprising fesoterodine
Dec, 2027

(3 years from now)

Active
US8088398 Pharmaceutical compositions comprising fesoterodine
Jun, 2027

(2 years from now)

Active
US7807715 Pharmaceutical compositions comprising fesoterodine
Jun, 2027

(2 years from now)

Active
US8501723 Pharmaceutical compositions comprising fesoterodine
Jun, 2027

(2 years from now)

Active
US6858650

(Pediatric)

Stable salts of novel derivatives of 3,3-diphenylpropylamines
Jan, 2023

(1 year, 9 months ago)

Expired
US6858650 Stable salts of novel derivatives of 3,3-diphenylpropylamines
Jul, 2022

(2 years ago)

Expired
US7985772 Derivatives of 3,3-diphenylpropylamines
May, 2019

(5 years ago)

Expired
US7384980 Derivatives of 3,3-diphenylpropylamines
May, 2019

(5 years ago)

Expired
US7855230 Derivatives of 3,3-diphenylpropylamines
May, 2019

(5 years ago)

Expired
US8338478 Derivatives of 3,3-diphenylpropylamines
May, 2019

(5 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Toviaz's patents.

Given below is the list of recent legal activities going on the following patents of Toviaz.

Activity Date Patent Number
Patent litigations
Expire Patent 28 Aug, 2023 US7985772 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 14 Jun, 2023 US8088398
Maintenance Fee Reminder Mailed 13 Mar, 2023 US7985772 (Litigated)
Expire Patent 23 Jan, 2023 US7855230 (Litigated)
Maintenance Fee Reminder Mailed 08 Aug, 2022 US7855230 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 23 Mar, 2022 US7807715
Expire Patent 01 Feb, 2021 US8338478 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 20 Jan, 2021 US8501723
Maintenance Fee Reminder Mailed 17 Aug, 2020 US8338478 (Litigated)
Expire Patent 13 Jul, 2020 US7384980 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Toviaz and ongoing litigations to help you estimate the early arrival of Toviaz generic.

Toviaz's Litigations

Toviaz been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 28, 2016, against patent number US8338478. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with UCB Pharma GmbH as the respondent. Click below to track the latest information on how companies are challenging Toviaz's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6858650 January, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Mylan Pharmaceuticals Inc
US6858650 August, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Torrent Pharmaceuticals Limited
US6858650 August, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Alembic Pharmaceuticals Limited
US6858650 August, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Amerigen Pharmaceuticals Limited
US7384980 January, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Mylan Pharmaceuticals Inc.
US7855230 January, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Mylan Pharmaceuticals Inc.
US7985772 January, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Mylan Pharmaceuticals Inc.
US8338478 January, 2016 FWD Entered
(19 Jul, 2017)
UCB Pharma GmbH Mylan Pharmaceuticals Inc.


FDA has granted some exclusivities to Toviaz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Toviaz, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Toviaz.

Exclusivity Information

Toviaz holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Toviaz's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 31, 2013
New Indication(I-861) Jun 17, 2024
Pediatric Exclusivity(PED) Dec 17, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Toviaz is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Toviaz's family patents as well as insights into ongoing legal events on those patents.

Toviaz's Family Patents

Toviaz has patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Toviaz.

Family Patents

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Generic Launch

Generic Release Date:

Toviaz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 07, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Toviaz Generics:

Fesoterodine Fumarate is the generic name for the brand Toviaz. 11 different companies have already filed for the generic of Toviaz, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Toviaz's generic

How can I launch a generic of Toviaz before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Toviaz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Toviaz's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Toviaz -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
4 mg and 8 mg 31 Oct, 2012 16 10 Dec, 2015 07 Jun, 2027 Eligible

Alternative Brands for Toviaz

Toviaz which is used for treating overactive bladder symptoms such as urge urinary incontinence, urgency, and frequency., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Apgdi
Myrbetriq used for treating neurogenic detrusor overactivity in pediatric patients and overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, including in combination with solifenacin succinate for more severe cases.





About Toviaz

Toviaz is a drug owned by Pfizer Inc. It is used for treating overactive bladder symptoms such as urge urinary incontinence, urgency, and frequency. Toviaz uses Fesoterodine Fumarate as an active ingredient. Toviaz was launched by Pfizer in 2008.

Approval Date:

Toviaz was approved by FDA for market use on 31 October, 2008.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Toviaz is 31 October, 2008, its NCE-1 date is estimated to be 18 December, 2023.

Active Ingredient:

Toviaz uses Fesoterodine Fumarate as the active ingredient. Check out other Drugs and Companies using Fesoterodine Fumarate ingredient

Treatment:

Toviaz is used for treating overactive bladder symptoms such as urge urinary incontinence, urgency, and frequency.

Dosage:

Toviaz is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
4MG TABLET, EXTENDED RELEASE Prescription ORAL
8MG TABLET, EXTENDED RELEASE Prescription ORAL