ALLEGAN, Mich., Sept. 24 /PRNewswire-FirstCall/ — Perrigo
PRGO; TASE) announced that it has filed with the U.S. Food and
Drug Administration (FDA) an Abbreviated New Drug Application
(ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic
equivalent of Zegerid OTC™, and that it provided prior notice
of this filing to Schering-Plough HealthCare Products, Inc. a
subsidiary of Merck & Co., Inc., the owner of the brand
regulatory approval and the Curators of the University of Missouri,
the listed patent owner.
On September 20, 2010, Schering-Plough filed suit alleging
patent infringement in the United States District Court of New
Jersey to prevent Perrigo from proceeding with the
commercialization of this product. This action formally initiates
the process under the Hatch-Waxman Act. In addition, Santarus, Inc.
and the Curators of the University of Missouri, licensor and owner
of the patents, were joined in the lawsuits as co-plaintiffs. In
connection with litigation relating to Zegerid®
brand prescription products, the U.S. District Court for the
District of Delaware ruled in April 2010 that the same patents
that are the subject of the present action were invalid due to
obviousness. An appeal of that decision was filed in May 2010,
and the appeal is pending.
The Perrigo product is generic equivalent to Schering-Plough’s
Zegerid-OTC™ (omeprazole 20 mg/sodium bicarbonate 1100mg) a
proton pump inhibitor and antacid indicated for the treatment of
frequent heartburn. Sales for the OTC brand are estimated to be
approximately $60 million annualized from the most recent month,
according to IRI.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This filing
is an example of our focus on bringing new Rx to OTC switch
products to market. It is a great addition to our diverse offering