VESIcare LS Generic: When Will Generic Solifenacin Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
VESIcare LS Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? April 2014 18 companies approved
- When does the last patent end? May 2031 Its only patent listed with the FDA
- Can you buy a generic today? Yes 29 companies list one
It already is. A generic solifenacin succinate is listed for sale by 29 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from VESIcare LS, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
VESIcare LS by the Numbers
- Reason
- Awaiting FDA approvalThe patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2020 May 2020 FDA Orange Book
- Patents listed 1 last runs to May 2031 FDA Orange Book
- Generics FDA-approved 18 companies, the first approved April 2014 FDA Orange Book
- Medicare Part D spent $31.6K in 2025, for 38 people CMS Part D Spending by Drug
VESIcare LS’s Road to a Generic
VESIcare LS has had the market to itself since the FDA approved it in May 2020 (Astellas Pharma US Inc). Its one listed patent runs to May 2031. Generic companies have challenged its patents with the FDA since May 2021.
The patents are not the problem. A generic still needs FDA sign-off, and that is when it is expected.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
VESIcare LS Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for VESIcare LS’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,918,970 | The product’s formulation | May 2031 | Active |
Source: FDA Orange Book, application 209529. Patent numbers open the patent on Google Patents.
Patent Challenges to VESIcare LS
The first patent challenge to VESIcare LS reached the FDA in May 2021, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before VESIcare LS’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Oral suspension, 1 mg/mL | May 2021 | 1 company | No decision yet | Not yet | Not yet | May 2031 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Solifenacin Succinate
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for VESIcare LS, but the FDA has already approved 18 companies (step 2), and every approval starts with an application.
Generic companies have challenged VESIcare LS’s patents with the FDA since May 2021: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 18 companies, the first in April 2014. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic solifenacin succinate is listed for sale by 29 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Amneal Pharmaceuticals NY LLC, Apotex Corp. and 23 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA | April 2014 | 5MG, 10MG | AB |
| Alembic Pharmaceuticals Ltd | May 2019 | 5MG, 10MG | AB |
| Alkem Laboratories Ltd | May 2019 | 5MG, 10MG | AB |
| Bostal LLC | May 2019 | 5MG, 10MG | AB |
| Chartwell Rx Sciences LLC | May 2019 | 5MG, 10MG | AB |
| Glenmark Specialty SA | May 2019 | 5MG, 10MG | AB |
| Msn Laboratories Private Ltd | May 2019 | 5MG, 10MG | AB |
| Qilu Pharmaceutical Co Ltd | May 2019 | 5MG, 10MG | AB |
| Sciegen Pharmaceuticals Inc | May 2019 | 5MG, 10MG | AB |
| Watson Laboratories Inc | May 2019 | 5MG, 10MG | AB |
| Unichem Laboratories Ltd | August 2019 | 5MG, 10MG | AB |
| Novitium Pharma LLC | September 2019 | 5MG, 10MG | AB |
| Rising Pharma Holdings Inc | December 2019 | 5MG, 10MG | AB |
| Sunshine Lake Pharma Co Ltd | April 2020 | 5MG, 10MG | AB |
| Annora Pharma Private Ltd | June 2022 | 5MG, 10MG | AB |
| Aurobindo Pharma Ltd | December 2022 | 5MG, 10MG | AB |
| Macleods Pharmaceuticals Ltd | February 2024 | 5MG, 10MG | AB |
| Jubilant Generics Ltd | October 2024 | 5MG, 10MG | AB |
| Ajanta Pharma Ltd discontinued | May 2019 | 5MG, 10MG | – |
| Amneal Pharmaceuticals Co GmbH discontinued | May 2019 | 5MG, 10MG | – |
| Breckenridge Pharmaceutical Inc discontinued | May 2019 | 5MG, 10MG | – |
| Cipla Ltd discontinued | May 2019 | 5MG, 10MG | – |
| Zydus Pharmaceuticals USA Inc discontinued | October 2020 | 5MG, 10MG | – |
| Accord Healthcare Inc discontinued | January 2022 | 5MG, 10MG | – |
| Lannett Co Inc discontinued | June 2023 | 5MG, 10MG | – |
| Torrent Pharmaceuticals Ltd discontinued | March 2025 | 5MG, 10MG | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
VESIcare LS Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for VESIcare LS, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on VESIcare LS
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on VESIcare LS, before manufacturer rebates.
- $31.6K
- 2025, the whole year
For 38 people, about $329 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $31,605 | 38 | $329.22 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name VESIcare LS only, so no generic is counted in it. What CMS says it is used for: Solifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination.
VESIcare LS Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1MG/ML | Suspension | Oral | May 2020 | Discontinued reference product |
Source: FDA Orange Book, Astellas Pharma US Inc.
What a Generic VESIcare LS Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about VESIcare LS
Is there a generic for VESIcare LS right now?
Yes. The FDA NDC Directory lists a generic solifenacin succinate from 29 companies. Ask your pharmacy whether it can fill your prescription with it.
When will VESIcare LS go generic?
It already has. The FDA NDC Directory lists a generic solifenacin succinate from 29 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic solifenacin succinate be the same as VESIcare LS?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 18 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic VESIcare LS?
Yes. The FDA Orange Book lists approved generic versions from 18 companies, the first approved in April 2014: Teva Pharmaceuticals USA, Alembic Pharmaceuticals Ltd, Alkem Laboratories Ltd, Bostal LLC and 14 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the VESIcare LS patent expire?
One patent is listed for VESIcare LS in the FDA Orange Book; it runs to May 2031. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
Has anyone challenged the VESIcare LS patents?
Yes. The first patent challenge to VESIcare LS reached the FDA in May 2021, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- BryhaliHalobetasol PropionateDuring 2026
- YonsaAbiraterone AcetateDuring 2026
- LivmarliMaralixibat ChlorideJanuary to June 2032
- TibsovoIvosidenib2037 to 2038
- FocinvezFosaprepitant DimeglumineJanuary 2039
- PonvoryPonesimodOctober 2042
About VESIcare LS
- Generic name solifenacin succinate
- How it is taken By mouth
- Company Astellas Pharma US Inc
- Patent challenges Since May 2021 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about VESIcare LS
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.