Perrigo Co. (PRGO) recently announced that the US Food and Drug Administration (FDA) granted approval to Tris Pharma’s abbreviated new drug application (ANDA) for its generic version of Reckitt Benckiser Group plc‘s (RBGPY) Delsym (dextromethorphan polistirex extended-release oral suspension). Perrigo is Tris Pharma’s exclusive partner for marketing and distributing the product in the US.
Meanwhile, litigation between Tris and Reckitt is continuing in the US District Court for the District of New Jersey. Previously, the court had granted a summary judgment of non-infringement of the asserted patent claims.
With Tris being the first company to file an ANDA with a para IV certification for the drug, Tris Pharma is entitled to 180 days of generic exclusivity.
Delsym is approved for the treatment of cough due to minor throat and bronchial irritation. As per Perrigo, Delsym sales for the last one year were approximately $110 million. Perrigo intends to launch generic Delsym in the next flu season.
Earlier this year, Perrigo gained approval for its generic version of KV Pharmaceutical Company’s vaginal cream Gynazole. Perrigo is working with KV Pharma towards making the generic version of Gynazole 1 available in the US by year end.
Our Recommendation
We currently have a Neutral recommendation on Perrigo. The stock carries a Zacks #3 Rank (short-term Hold rating).
We believe Perrigo has a sustainable and diversified product portfolio. The company’s strong position in the brand over-the-counter pharmaceutical market and growing generics and active pharmaceuticals ingredient businesses are expected to drive growth in the coming quarters. We are also impressed by Perrigo’s strong pipeline.
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