Generic Toviaz Availability
Last updated on Nov 6, 2024.
Toviaz is a brand name of fesoterodine, approved by the FDA in the following formulation(s):
TOVIAZ (fesoterodine fumarate - tablet, extended release;oral)
Has a generic version of Toviaz been approved?
A generic version of Toviaz has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Toviaz and have been approved by the FDA:
fesoterodine fumarate tablet, extended release;oral
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Manufacturer: ALEMBIC
Approval date: January 4, 2023
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: ALKEM LABS LTD
Approval date: December 10, 2015
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: AMNEAL PHARMS NY
Approval date: January 4, 2023
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: AUROBINDO PHARMA
Approval date: February 17, 2017
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: DR REDDYS
Approval date: August 13, 2019
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: HETERO LABS LTD V
Approval date: January 9, 2024
Strength(s): 4MG [AB], 8MG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: October 3, 2017
Strength(s): 4MG [AB], 8MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Toviaz. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Patent 7,807,715
Patent expiration dates:
- June 7, 2027✓✓
- June 7, 2027
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Patent 7807715*PED
Patent expiration dates:
- December 7, 2027✓
- December 7, 2027
-
Pharmaceutical compositions comprising fesoterodine
Patent 8,088,398
Issued: January 3, 2012
Inventor(s): Mika Hans-Jürgen & Arth Christoph & Komenda Michael & Bicane Fatima
Assignee(s): UCB Pharma GmbHThe present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Patent expiration dates:
- June 7, 2027✓✓
- June 7, 2027
-
Pharmaceutical compositions comprising fesoterodine
Patent 8088398*PED
Issued: January 3, 2012
Inventor(s): Mika Hans-Jürgen & Arth Christoph & Komenda Michael & Bicane Fatima
Assignee(s): UCB Pharma GmbHThe present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Patent expiration dates:
- December 7, 2027✓
- December 7, 2027
-
Pharmaceutical compositions comprising fesoterodine
Patent 8,501,723
Issued: August 6, 2013
Inventor(s): Mika Hans-Jürgen & Arth Christoph & Komenda Michael & Bicane Fatima & Paulus Kerstin & Irngartinger Meike & Lindner Hans
Assignee(s): UCB Pharma GmbHThe present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Patent expiration dates:
- June 7, 2027✓
- June 7, 2027
-
Pharmaceutical compositions comprising fesoterodine
Patent 8501723*PED
Issued: August 6, 2013
Inventor(s): Mika Hans-Jürgen & Arth Christoph & Komenda Michael & Bicane Fatima & Paulus Kerstin & Irngartinger Meike & Lindner Hans
Assignee(s): UCB Pharma GmbHThe present application relates to a pharmaceutical granulate comprising Fesoterodine or a pharmaceutically acceptable salt or solvate thereof and a pharmaceutically acceptable stabilizer, which can be selected from the group consisting of sorbitol, xylitol, polydextrose, isomalt, dextrose, and combinations thereof, and is preferably a sugar alcohol selected from the group consisting of xylitol and sorbitol. The granulate is suitable for incorporation into pharmaceutical compositions comprising a gel matrix formed by at least one type of hydroxypropyl methylcellulose into which the Fesoterodine is embedded and, optionally, further excipients. In certain embodiments, the granulate is formed by a process of wet granulation.
Patent expiration dates:
- December 7, 2027✓
- December 7, 2027
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- June 17, 2024 - TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
- December 17, 2024 - PEDIATRIC EXCLUSIVITY
More about Toviaz (fesoterodine)
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- Drug class: urinary antispasmodics
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.