Vesicare Ls is a drug owned by Astellas Pharma Us Inc. It is protected by 1 US drug patent filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 18, 2031. Details of Vesicare Ls'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). | |||
| US9918970 | Pharmaceutical composition comprising solifenacin |
May, 2031
(6 years from now) | Active |
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 Vesicare Ls's patents.
Latest Legal Activities on Vesicare Ls's Patents
Given below is the list of recent legal activities going on the following patents of Vesicare Ls.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Sep, 2021 | US9918970 |
| Recordation of Patent Grant Mailed Critical | 20 Mar, 2018 | US9918970 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Mar, 2018 | US9918970 |
| Mail Pre-Exam Notice | 01 Mar, 2018 | US9918970 |
| Email Notification Critical | 01 Mar, 2018 | US9918970 |
| Electronic Review Critical | 01 Mar, 2018 | US9918970 |
| Issue Notification Mailed Critical | 28 Feb, 2018 | US9918970 |
| Dispatch to FDC | 26 Jan, 2018 | US9918970 |
| Reverse Issue Fee | 19 Jan, 2018 | US9918970 |
| Issue Fee Payment Verified Critical | 18 Jan, 2018 | US9918970 |
FDA has granted several exclusivities to Vesicare Ls. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vesicare Ls, 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 Vesicare Ls.
Exclusivity Information
Vesicare Ls holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Vesicare Ls's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 26, 2023 |
| Pediatric Exclusivity(PED) | Nov 26, 2023 |
| W(W) | Nov 26, 2023 |
US patents provide insights into the exclusivity only within the United States, but Vesicare Ls 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 Ls's family patents as well as insights into ongoing legal events on those patents.
Vesicare Ls's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vesicare Ls's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 18, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vesicare Ls Generic API suppliers:
Solifenacin Succinate is the generic name for the brand Vesicare Ls. 25 different companies have already filed for the generic of Vesicare Ls, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vesicare Ls's generic
How can I launch a generic of Vesicare Ls before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vesicare Ls's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vesicare Ls'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 Ls -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 27 May, 2021 | 1 | 18 May, 2031 |
Alternative Brands for Vesicare Ls
There are several other brand drugs using the same active ingredient (Solifenacin Succinate) as Vesicare Ls. 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 Ls's active ingredient. Check the complete list of approved generic manufacturers for Vesicare Ls
About Vesicare Ls
Vesicare Ls is a drug owned by Astellas Pharma Us Inc. Vesicare Ls uses Solifenacin Succinate as an active ingredient. Vesicare Ls was launched by Astellas in 2020.
Approval Date:
Vesicare Ls was approved by FDA for market use on 26 May, 2020.
Active Ingredient:
Vesicare Ls uses Solifenacin Succinate as the active ingredient. Check out other Drugs and Companies using Solifenacin Succinate ingredient
Dosage:
Vesicare Ls is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML | SUSPENSION | Prescription | ORAL |