Patent Challenge from Perrigo

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Recently, Perrigo Company (PRGO) announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (:FDA) seeking approval to market its generic version of AbbVie Inc.’s (ABBV) Androgel 1.62%. Perrigo believes that it is the first-to-file, entitling it to 180 days exclusivity of generic Androgel 1.62%.

We note that AndroGel 1.62% (testosterone gel 1.62%) is marketed for treating males (above 18 years of age) with low or no testosterone in their body. The annual sales of this product were approximately $680 million, according to data released by Wolters Kluwer Health.

AbbVie came into existence earlier this year following its separation from Abbott Laboratories (ABT). AbbVie provided its guidance for 2013. The company expects to earn $3.03–$3.13 per share in 2013 on total revenues of more than $18 billion. Currency movement is expected to negatively impact revenues by about 1%.

We remind investors that Perrigo reported lower-than-expected revenues, but higher-than-expected earnings in its second quarter 2013 (ended Dec 29, 2012).

Apart from announcing its financial results, Perrigo inked a deal to buy animal health company Velcera, Inc. for $160 million in cash. The deal is expected to close in calendar year 2013. Perrigo intends to strengthen its position in the OTC retail pet healthcare market through the impending acquisition.

Perrigo, which develops, manufactures and distributes OTC and generic prescription pharmaceuticals among others, carries a Zacks Rank #2 (Buy) in the short-run. Meanwhile, biopharma stock, Actelion Ltd. (ALIOF) has a Zacks Rank #1 (Strong Buy).

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