Amerigen Gets Tentative FDA Approval for Generic Toviaz

The FDA granted tentative approval of Amerigen Pharmaceuticals’ generic Toviaz for overactive bladder.

Amerigen says it believes it is the first to file an ANDA for the Pfizer drug, giving it Paragraph IV certification under the Hatch-Waxman Act and 180 days of exclusivity should the approval become final. The Lyndhurst, N.J., generics maker plans to sell its version of Toviaz in 4 mg and 8 mg extended-release tablets.

Meanwhile, Pfizer has a lawsuit pending in the U.S. district court in Delaware accusing Amerigen of infringing its ’650, ’980, ’230, ’772 and ’478 patents for Toviaz. A 10-day trial in       Pfizer Inc. and UCB Pharma GMBH v. Amerigen Pharmaceuticals is scheduled to start July 13, according to court records.

Toviaz (fesoterodine fumarate) is indicated for overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. U.S. sales of the drug in 2014 were roughly $215 million, according to IMS Health. — Jonathon Shacat