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Last Updated: July 11, 2020

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Solifenacin succinate - Generic Drug Details

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What are the generic sources for solifenacin succinate and what is the scope of freedom to operate?

Solifenacin succinate is the generic ingredient in three branded drugs marketed by Astellas, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Celltrion, Cipla, Glenmark Pharms Inc, Graviti Pharms, Jiangxi Boya Seehot, MSN, Qilu, Sciegen Pharms Inc, Strides Pharma, Sunshine Lake, Teva Pharms Usa, Unichem Labs Ltd, and Watson Labs Inc, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for solifenacin succinate. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for solifenacin succinate

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Recent Clinical Trials for solifenacin succinate

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SponsorPhase
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaPhase 4
Ono Pharmaceutical Co. LtdPhase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 4

See all solifenacin succinate clinical trials

Generic filers with tentative approvals for SOLIFENACIN SUCCINATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for solifenacin succinate
Medical Subject Heading (MeSH) Categories for solifenacin succinate
Paragraph IV (Patent) Challenges for SOLIFENACIN SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
VESICARE TABLET;ORAL solifenacin succinate 021518 2009-04-08

US Patents and Regulatory Information for solifenacin succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem Labs Ltd SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 211701-002 Aug 27, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Jiangxi Boya Seehot SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210281-001 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Inc SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209239-001 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Celltrion SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210582-002 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Qilu SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 209333-002 May 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Merck
Moodys
Johnson and Johnson
Baxter

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.