) recently confirmed that it has filed an abbreviated new drug
application (ANDA) with the US Food and Drug Administration (FDA),
seeking approval for its generic version of
Teva Pharmaceutical Industries Limited
) ProAir HFA inhaler. The application included contributions from
Perrigo's partner on the project, the privately-held Catalent
PERRIGO COMPANY (PRGO): Free Stock Analysis
TEVA PHARM ADR (TEVA): Free Stock Analysis
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ProAir is marketed for treating and preventing bronchospasm
symptoms in patients aged 4 years and above. As per data released
by Wolters Kluwer Health, annual sales of the inhaler were
approximately $1.07 billion.
We note that Teva has already challenged Perrigo's application,
thereby initiating the litigation process under the Hatch-Waxman
Act. Perrigo stated in its press release that it is the first
company to seek approval for the generic version of the drug and is
therefore entitled to 180 days of generic exclusivity.
We note that the generic segment at Perrigo (Rx Pharmaceuticals)
performed exceptionally well in fiscal 2012 (ended June 30, 2012)
with sales climbing 80% year over year to $274 million. The generic
unit has seen quite a few approvals over the past few months
including its generic versions of Clobex shampoo, inflammatory acne
therapy Duac gel, hyperphosphatemia drug, Phoslo Gelcaps and
vaginal cream Gynazole 1 for the local treatment of vulvovaginal
Earlier in the month, we downgraded Perrigo to Neutral from
Outperform following the disappointing revenue numbers reported by
the company in the fourth quarter of fiscal 2012.
Perrigo's fourth quarter fiscal 2012 revenues of $832 million fell
short of the Zacks Consensus Estimate of $854 million, primarily
due to weakness in the Consumer HealthCare segment. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.