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
(2 years from now) | Active |
|
US8501723 (Pediatric) | Pharmaceutical compositions comprising fesoterodine |
Dec, 2027
(2 years from now) | Active |
|
US8088398 (Pediatric) | Pharmaceutical compositions comprising fesoterodine |
Dec, 2027
(2 years from now) | Active |
| US7807715 | Pharmaceutical compositions comprising fesoterodine |
Jun, 2027
(1 year, 10 months from now) | Active |
| US8088398 | Pharmaceutical compositions comprising fesoterodine |
Jun, 2027
(1 year, 10 months from now) | Active |
| US8501723 | Pharmaceutical compositions comprising fesoterodine |
Jun, 2027
(1 year, 10 months from now) | Active |
|
US6858650 (Pediatric) | Stable salts of novel derivatives of 3,3-diphenylpropylamines |
Jan, 2023
(2 years ago) |
Expired
|
| US6858650 | Stable salts of novel derivatives of 3,3-diphenylpropylamines |
Jul, 2022
(3 years ago) |
Expired
|
| US7985772 | Derivatives of 3,3-diphenylpropylamines |
May, 2019
(6 years ago) |
Expired
|
| US7384980 | Derivatives of 3,3-diphenylpropylamines |
May, 2019
(6 years ago) |
Expired
|
| US7855230 | Derivatives of 3,3-diphenylpropylamines |
May, 2019
(6 years ago) |
Expired
|
| US8338478 | Derivatives of 3,3-diphenylpropylamines |
May, 2019
(6 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 28 Aug, 2023 | US7985772 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jun, 2023 | US8088398 |
| Maintenance Fee Reminder Mailed Critical | 13 Mar, 2023 | US7985772 (Litigated) |
| Expire Patent Critical | 23 Jan, 2023 | US7855230 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 08 Aug, 2022 | US7855230 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Mar, 2022 | US7807715 |
| Expire Patent Critical | 01 Feb, 2021 | US8338478 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jan, 2021 | US8501723 |
| Maintenance Fee Reminder Mailed Critical | 17 Aug, 2020 | US8338478 (Litigated) |
| Expire Patent Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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. All of its exclusivities have expired 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||
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 |