FDA Approves Generic Treatments for Overactive Bladder

Alembic Pharmaceuticals and Glenmark 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

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

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

In the United States, solifenacin succinate tablets, 5 mg and 10 mg, have an estimated market size of $927 million to $967 million for the 12 months ended 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 portfolio consists of 154 products authorized for distribution in the United States and 58 ANDAs pending approval with the FDA.²

In April, Teva launched its version of solifenacin succinate tablets, 5 mg and 10 mg.³

References

• Alembic Pharmaceuticals receives USFDA approval for solifenacin succinate tablets, 5 mg and 10 mg [news release]. Vadodara, India; May 21, 2019: Alembic. alembicpharmaceuticals.com/wp-content/uploads/2019/05/Press-Release-USFDA-Approval-Solifenacin-Succinate-Tablets-May-2019.pdf. Accessed May 21, 2019.
• Glenmark Pharmaceuticals receives ANDA approval for solifenacin succinate tablets, 5 mg and 10 mg [news release]. Mumbai, India; May 21, 2019: Glenmark. glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Solifenacin-Succinate-Tablets-5-mg-and-10-mg.pdf. Accessed May 21, 2019.
• Teva announces launch of a generic version of VESIcare® (solifenacin succinate) tablets in the United States [news release]. Jerusalem; April 22, 2019: Teva. ir.tevapharm.com/investors/press-releases/press-release-details/2019/Teva-Announces-Launch-of-a-Generic-Version-of-VESIcaresolifenacin-succinateTablets-in-the-United-States/default.aspx. Accessed May 21, 2019.