Dr. Reddy's Laboratories is gunning for Pfizer’s extended-release overactive bladder treatment Toviaz, introducing a therapeutic generic equivalent that could threaten more than $200 million in revenues.
The FDA approved Pfizer’s once-daily overactive bladder treatment Toviaz in 2008. The approval gave the Big Pharma company a new growth driver ahead of the expiration of the patent on its existing overactive bladder treatment, Detrol LA. Toviaz has consistently brought in more than $200 million a year, although sales slipped around 5% to $238 million in 2021.
Dr. Reddy’s has introduced a threat to those sales. After securing FDA approval, the Indian pharma firm has launched fesoterodine fumarate extended-release tablets, a therapeutic generic equivalent to Toviaz. Like Toviaz, the generic is available in doses of 4 mg and 8 mg.
The generic is indicated for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency and frequency. Because of Pfizer’s marketing exclusivity rights, the product is not labeled with information on pediatric use.
Launching the Toviaz equivalent in the U.S. gives Dr. Reddy’s a new potential growth driver. Last year, new product launches helped the company to achieve double-digit sales growth. The North American generic unit grew 6% as price erosion partly offset the new product launches and the growth of existing products.
The Toviaz copy is part of a batch of planned launches. As of May, Dr. Reddy’s had 90 generic filings pending approval at the FDA, including 24 applications that it believed had first-to-file status.