) recently announced that it had received US Food and Drug
Administration (FDA) approval for its abbreviated new drug
application (ANDA) for the generic version of Duac Gel.
With the Perrigo ANDA being the first para IV filing, Perrigo
should be entitled to 180-days marketing exclusivity for its
generic version. The FDA is yet to decide on the exclusivity
status. Perrigo has already started shipment.
Duac Gel, developed by Stiefel, a
) company, is a clindamycin phosphate and benzoyl peroxide 1.2%/5%
topical gel for the treatment of inflammatory acne (pimples). The
product recorded annual sales of around $130 million last year.
We note that the acne market has been in the news recently with
Impax Laboratories Inc.
) receiving FDA approval for their respective generic versions of
) Doryx (150 mg). Mylan has already commenced shipping the
We note that Perrigo has received quite a few approvals on the
generic front over the past few weeks. Earlier this month, Perrigo
received FDA approval for its generic version of hyperphosphatemia
drug Phoslo Gelcaps.
The FDA also cleared Perrigo's generic version of KV
Pharmaceutical Company's vaginal cream Gynazole. Moreover, the FDA
gave final approval to Perrigo to market its generic version of
) heartburn drug, Prevacid. Approval was granted to treat patients
suffering from frequent heartburn (two or more days in a week).
Perrigo launched the drug in the US following receipt of final
approval from the FDA.
We note that the availability of generic equivalents will be
easy on the pockets of patients as generic drugs are much cheaper
than their branded counterparts.
We currently have a Neutral recommendation on Perrigo. The stock
carries a Zacks #3 Rank (short-term Hold rating).
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