Impax Laboratories Inc. (IPXL) recently announced that it is looking to get its generic version of Pfizer Inc. (PFE) and UCB Pharma GmbH’s Toviaz (fesoterodine fumarate) tablets (4 mg and 8 mg) approved in the US. The company has filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for its candidate.
The FDA informed the innovator companies about the ANDA filing following its acceptance of the same.
Toviaz is approved for reducing overactive bladder (OAB) symptoms. As per IMS Health, 12 month US sales of Toviaz (4 mg and 8 mg) were $159 million as of May 31, 2013.
Once the generic version is approved, Global Pharmaceuticals, which handles Impax’ generic operations, will commercialize the product.
Pfizer and UCB have filed a patent infringement lawsuit against Impax in the US District Court for the District of Delaware. The filing of the lawsuit within the stipulated time period under the Hatch-Waxman Act ensures that the FDA cannot grant final approval to Impax’ generic for up to 30 months or the court’s decision, whichever is earlier.
We note that Impax is actively working on strengthening its generic products portfolio. In May 2013, the company launched its authorized generic version of AstraZeneca’s (AZN) Zomig tablets and orally disintegrating tablets in the US as per the terms of its agreement with AstraZeneca. Zomig is approved for treating headaches due to migraine in adults.
Impax currently carries a Zacks Rank #3 (Hold). Other generic players like Mylan, Inc. (MYL) currently look better positioned with a Zacks Rank #2 (Buy).
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