Perrigo’s omeprazole OTC?
This article was originally published in The Tan Sheet
Executive Summary
FDA issues an approvable letter to Perrigo's Israeli partner, Dexcel Pharma Technologies, for its generic Prilosec OTC (omeprazole 20 milligrams) new drug application on Dec. 18, according to the Allegan, Mich.-based firm in a same-day release. Perrigo plans on being the exclusive marketer and distributor of Dexcel's generic Prilosec OTC in the U.S. once the agency approves the application, the firm states. Currently, the company is facing pending litigation from AstraZeneca over the generic version of the over-the-counter heartburn drug. Dexcel filed the ANDA for OTC omeprazole in April 2006. Patent-holder AstraZeneca filed lawsuits in Delaware and Virginia in late May, alleging Dexcel's application infringes on three patents: two expiring in Oct. 2007 and one slated to expire in May 2019 (1"The Tan Sheet" June 12, 2006, p. 5). The litigation has initiated the patent challenge process under Hatch/Waxman and places a 30-month stay on FDA approval of the generic Prilosec OTC...
You may also be interested in...
Perrigo Foresees 2008 Omeprazole Launch; New Products Offset Sales Woes
Perrigo expects to be able to launch the first store-brand equivalent to Prilosec OTC in November 2008, at the expiration of a 30-month stay
Generic Prilosec OTC ANDA Filed By Perrigo Partner Dexcel; AstraZeneca Sues
Perrigo has acquired marketing rights for a potential generic version of Prilosec OTC, but litigation against the firm's partner Dexcel Pharma by AstraZeneca could block generic OTC omeprazole through 2019
Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says
The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.