Generic Overactive Bladder Drugs Receive FDA Approval

Glenmark Pharmaceuticals and Alembic Pharmaceuticals have both received FDA approval for generic Solifenacin Succinate Tablets, 5 mg and 10 mg, a therapeutic equivalent to Astellas’ Vesicare Tablets, 5 mg and 10 mg.1,2

Glenmark and Alembic are among a small handful of companies, including Teva, working to produce this medication.1-3

Solifenacin succinate tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.1

In the United States, solifenacin succinate tablets, 5 mg and 10 mg have an estimated market size of $927-967 million for 12 months ending December 2018 according to IQVIA.1-3

According to Alembic, the company has a total of 94 Abbreviated New Drug Application (ANDA) approvals, including 82 final approvals and 12 tentative approvals, from the FDA.1

Glenmark’s current portfolio consists of 154 products authorized for distribution in the United States and 58 ANDAs pending approval with the FDA.2

Teva announced in April the launching of its version of solifenacin succinate Tablets, 5 mg and 10 mg.3

  1. Alembic Pharmaceuticals receives USFDA Approval for Solifenacin Succinate Tablets, 5 mg and 10 mg [news release]. Vadodara, India; May 21, 2019: Alembic. Accessed May 21, 2019.
  2. Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets, 5 mg and 10 mg [news release]. Mumbai, India; May 21, 2019: Glenmark. Accessed May 21, 2019.
  3. Teva Announces Launch of a Generic Version of VESIcare® (solifenacin succinate) Tablets in the United States [news release]. Jerusalem; April 22, 2019: Teva. Accessed May 21, 2019.

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