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To: fourptt who wrote (27933)4/1/1999 1:37:00 AM
From: Doug R  Respond to of 79230
 
4,

CPLY news is as follows:

Schering sues Copley to protect a Claritin patent

WILMINGTON, Del., March 22 (Reuters) - Schering-Plough Corp. subsidiary Schering Corp has sued Copley Pharmaceutical Inc. to try to block it from marketing a generic syrup which allegedly infringes Schering's patent rights to the metabolized form of its antihistamine Claritin.

In papers filed Friday in the U.S. District Court in Delaware, Schering, of Kenilworth, New Jersey, said Copley has applied to the U.S. Food and Drug Administration for an Abbreviated New Drug Application (ANDA) to sell a generic syrup containing loratidine, an antihistamine used in Claritin.

Copley alleges in its ANDA that Schering's patent for desloratidine, which expires in 2004 and is a metabolite of loratidine, is invalid.

Schering spokesman William O'Donnell said the company "is contesting the new drug application filed by Copley for loratadine syrup...We believe our patents are valid and enforceable" and will use the federal lawsuit to defend them.

Copley spokesman Gene Bauer said the company does not plan to market a generic syrup until after the 2002 expiration date of Schering's patent for the loratidine compound, the validity of which Copley is not challenging.

ANDA approval can take 18 to 24 months, and Schering's lawsuit would impose a 30-month stay even if the ANDA were to be approved, Bauer said.

But the timing would allow Copley to be first in the market with a generic once the loratidine compound patent expires in 2002, and that early entry could earn a company a 180-day exclusivity award from the FDA, according to Bauer.

O'Donnell said Schering's 1998 U.S. sales for all five forms of Claritin, the world's best selling anti-histamine, were $1.9 billion. The only form of Claritin at issue in the Copley litigation is the syrup, and O'Donnell said sales figures for each of the five forms, which include capsules and syrups, are not broken out.

Copley, of Canton, Massachusetts, makes generic prescription and over-the-counter drugs.
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As per NPCI:
NPCI activity can very well be considered within the bounds of a retest. Nothing more than that can be intimated from the chart as of yet.

And...the 3rd of 4 probable GTFIs for this week, ULB, signaled hellaciously at the close today.

Doug R