P&G Targets OTC Omeprazole

24 June 2002 00:00  [Source: ICB Americas]

Procter & Gamble Company (P&G) and AstraZeneca PLC (AZ) are gearing up for a nonprescription over-the-counter (OTC) version of AZ's Prilosec (omeprazole). Upon approval by the Food and Drug Administration (FDA), the companies expect US sales of $200 million to $400 million annually for the OTC product.

A FDA advisory panel was expected to vote last week on whether to recommend approval for the OTC formulation of AZ's $6 billion heartburn drug.

"We have an exclusive agreement to market and distribute OTC Prilosec if approved by the FDA. We are working jointly to gain FDA approval in a Prilosec OTC formulation and expect a decision this summer," says Greg Allgood, associate director of the P&G Health Sciences Institute.

If approved, Prilosec would be the first proton pump inhibitor to move to OTC status. The drug would compete with Merck & Co.'s Pepcid.

Andrx Corp. and other generic manufacturers are involved in a legal battle with AZ to market generic prescription omeprazole. Andrx was granted 180-day marketing exclusivity on the 40 mg omeprazole dosage and shares such rights with Genpharm Inc. on 10 and 20 mg dosages.

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