FDA Nod for Perrigo Generic

Perrigo Co. ( PRGO - Analyst Report ) 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 GlaxoSmithKline plc ( GSK - Analyst Report ) 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 Mylan, Inc. ( MYL - Analyst Report ) and Impax Laboratories Inc. ( IPXL - Snapshot Report ) receiving FDA approval for their respective generic versions of Warner Chilcott’s ( WCRX - Analyst Report ) Doryx (150 mg). Mylan has already commenced shipping the product.

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 Novartis’ ( NVS - Snapshot Report ) 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.

Our Recommendation

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).