VESICARE Drug Patent Profile
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When do Vesicare patents expire, and what generic alternatives are available?
Vesicare is a drug marketed by Astellas and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in VESICARE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vesicare
A generic version of VESICARE was approved as solifenacin succinate by TEVA PHARMS USA on April 2nd, 2014.
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Questions you can ask:
- What is the 5 year forecast for VESICARE?
- What are the global sales for VESICARE?
- What is Average Wholesale Price for VESICARE?
Summary for VESICARE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 172 |
| Clinical Trials: | 67 |
| Patent Applications: | 1,864 |
| Drug Prices: | Drug price information for VESICARE |
| Drug Sales Revenues: | Drug sales revenues for VESICARE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VESICARE |
| What excipients (inactive ingredients) are in VESICARE? | VESICARE excipients list |
| DailyMed Link: | VESICARE at DailyMed |
Recent Clinical Trials for VESICARE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hikma Pharma | Phase 1 |
| Genuine Research Center, Egypt | Phase 1 |
| Brigitte Schürch | Phase 4 |
Pharmacology for VESICARE
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Paragraph IV (Patent) Challenges for VESICARE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VESICARE | Tablets | solifenacin succinate | 5 mg and 10 mg | 021518 | 1 | 2009-04-08 |
US Patents and Regulatory Information for VESICARE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-001 | Nov 19, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-002 | Nov 19, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astellas | VESICARE LS | solifenacin succinate | SUSPENSION;ORAL | 209529-001 | May 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VESICARE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-001 | Nov 19, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-002 | Nov 19, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VESICARE
See the table below for patents covering VESICARE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69529844 | ⤷ Sign Up | |
| China | 1045601 | ⤷ Sign Up | |
| Germany | 122004000048 | ⤷ Sign Up | |
| Australia | 4355396 | ⤷ Sign Up | |
| Hungary | 223778 | Új kinuklidinszármazékok és ezeket tartalmazó gyógyászati készítmények (NOVEL QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITION THEREOF) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VESICARE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0801067 | C00801067/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006 |
| 0801067 | SPC/GB04/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SOLIFENACIN AND/OR PHARMACEUTICALLY ACTIVE SALT THEREOF; REGISTERED: NL RVG 29151 20031216; NL RVG 29152 20031216; UK PL 00166/0197 20040816; UK PL 0016/0198 20040816 |
| 0801067 | 91133 | Luxembourg | ⤷ Sign Up | 91133, EXPIRES: 20181118 |
| 0801067 | CA 2004 00037 | Denmark | ⤷ Sign Up | |
| 0801067 | 04C0032 | France | ⤷ Sign Up | PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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