) 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
) 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
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.
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
PERRIGO COMPANY (PRGO): Free Stock Analysis
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