Impax Laboratories Inc.
) recently announced that it is looking to get its generic
) 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
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
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
) 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
) currently look better positioned with a Zacks Rank #2 (Buy).
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