The US Food and Drug Administration (FDA) recently approved
) Abbreviated New Drug Applications (ANDAs) to market
over-the-counter nicotine polacrilex mini lozenge, 2 mg (mint
flavor) and 4 mg (mint flavor). Perrigo expects to start shipping
the product by year end.
Mini nicotine lozenges help to reduce withdrawal symptoms like
nicotine craving, associated with quitting smoking. This is the
first approval for mini lozenge products targeting the store brand
market. The mint flavored mini lozenge can be compared to
) Nicorette mini lozenge.
We note that Glaxo markets Nicorette (Original, Mint and Orange)
globally. Perrigo stated in its press release that annual sales of
Nicorette mini lozenge are more than $30 million at all retail
We remind investors that last month Perrigo filed an ANDA with
the 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
Teva is challenging Perrigo's application, thereby initiating
the litigation process under the Hatch-Waxman Act. Perrigo 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 also note that the generic unit at Perrigo 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 candidiasis.
We currently have a Neutral recommendation on Perrigo. The stock
carries a Zacks #3 Rank (Hold) in the short run.
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