Impax Laboratories, Inc.
) and Teva Pharmaceuticals USA, Inc., a wholly owned subsidiary of
Teva Pharmaceutical Industries Limited
) recently announced that they have settled a patent infringement
lawsuit related to Concerta.
Impax and Teva entered into a settlement agreement with
Johnson and Johnson's
) Janssen Pharmaceuticals, Inc. and ALZA Corporation. ALZA and
Janssen had filed a patent infringement lawsuit against Impax in
Impax and Teva are looking to launch their generic version of
Concerta (18 mg, 27 mg, 36 mg, and 54 mg). Concerta is approved for
the treatment of attention deficit hyperactive disorder in children
six years of age and older, adolescents and adults up to the age of
Per the terms of the settlement agreement, Impax and Teva may
sell their generic version of Concerta from July 14, 2013 or
earlier in certain cases. Concerta sales (both branded and generic)
in the US, as per Wolters Kluwer Health, during the 12 months ended
July 2012 were about $1.2 billion. Currently, an authorized generic
version of Concerta is marketed by
Watson Pharmaceuticals, Inc.
We note that Impax is yet to gain US Food and Drug
Administration (FDA) approval for its generic version of Concerta.
Once the generic version is approved, Teva will commercialize the
product as per the terms of its agreement with Impax.
Impax' agreement with Teva covers generic versions of 10
controlled-release generic pharmaceutical branded and
over-the-counter (OTC) products. These products represent 18
different product/strength combinations.
We currently have a Neutral recommendation on Impax. The stock,
however, carries a Zacks #2 Rank (short-term 'Buy' rating).
IMPAX LABORATRS (IPXL): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
TEVA PHARM ADR (TEVA): Free Stock Analysis
WATSON PHARMA (WPI): Free Stock Analysis Report
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