Vesicare is a drug owned by Astellas Pharma Us Inc. It is protected by 2 US drug patents filed from 2013 to 2017 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 19, 2019. Details of Vesicare'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). | |||
|
US6017927 (Pediatric) | Quinuclidine derivatives and medicinal composition thereof |
May, 2019
(5 years ago) |
Expired
|
| US6017927 | Quinuclidine derivatives and medicinal composition thereof |
Nov, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Vesicare 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 Vesicare's family patents as well as insights into ongoing legal events on those patents.
Vesicare's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vesicare's generic launch date based on the expiry of its last outstanding patent is estimated to be May 19, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vesicare Generic API suppliers:
Solifenacin Succinate is the generic name for the brand Vesicare. 25 different companies have already filed for the generic of Vesicare, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vesicare's generic
How can I launch a generic of Vesicare before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vesicare's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vesicare'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 Vesicare -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 08 Apr, 2009 | 1 | 02 Apr, 2014 | 09 Nov, 2018 | Deferred |
Alternative Brands for Vesicare
There are several other brand drugs using the same active ingredient (Solifenacin Succinate) as Vesicare. 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 | |
|---|---|---|
| Astellas |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Solifenacin Succinate, Vesicare's active ingredient. Check the complete list of approved generic manufacturers for Vesicare
About Vesicare
Vesicare is a drug owned by Astellas Pharma Us Inc. Vesicare uses Solifenacin Succinate as an active ingredient. Vesicare was launched by Astellas in 2004.
Approval Date:
Vesicare was approved by FDA for market use on 19 November, 2004.
Active Ingredient:
Vesicare uses Solifenacin Succinate as the active ingredient. Check out other Drugs and Companies using Solifenacin Succinate ingredient
Dosage:
Vesicare is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |