Schering-Plough Loses Patent Lawsuit Over Claritin, Opening Door For Cheaper Generic Versions

    CARSON, Calif., Aug. 5 /PRNewswire/ -- After months of delay, consumers
 can now reap even more savings from prescription Claritin(R) switching to over
 the counter. On August 1, 2003, the United States Court of Appeals for the
 Federal Circuit ruled against Schering-Plough's patent challenge claiming that
 generic manufacturers of loratadine (active ingredient in Claritin) would be
 infringing upon its Clarinex(R) patents. This means Americans will soon be
 able to purchase Leiner Health Products private label version of loratadine
 10 mg tablets for an average price of 30 cents per pill compared to Claritin's
 $1.00 price.
     "The court's ruling puts the brakes on the pharmaceutical industry's anti-
 competitive behavior blocking generic manufacturers from the market while
 protecting their estimated Claritin sales of $400 million per year," said Gale
 Bensussen, President Leiner Health Products.
     "Through an exclusive licensing agreement with Genpharm Inc., an affiliate
 of Merck KGaA, and Pharmaceutical Resources (NYSE:   PRX), Spring Valley, N.Y.
 Leiner will be shipping private label versions of loratadine 10mg tablet to
 the nation's leading food, drug, club and mass retailers by the end of August.
 We expect the retail price to be between 10-40 cents per pill. When you
 compare this to the $2.78 cost per pill of prescription Claritin, the savings
 are staggering," added Bensussen.
     Schering argued manufacturers of the generic loratadine would be
 infringing upon the Clarinex patent because when digested loratadine results
 in the production of desloratadine (the active ingredient in Clarinex) in the
 body. In ruling against Schering's claim, the US appellate court found no
 patent infringement. Desloratadine the active ingredient in Clarinex was found
 neither to be new nor a unique ingredient warranting patent protection.
     In addition to the court's lawsuit ruling, another regulatory hurdle was
 cleared. The first generic manufacturer of 10 mg loratadine, Geneva/Novartis'
 marketing exclusivity patent expired July 22, 2003. Under the 1984 Waxman-
 Hatch Act, FDA can't approve any other abbreviated new drug applications
 (ANDA) until all contested patent lawsuits are resolved or 30 months expires
 from the date of the lawsuit was filed, which ever occurs first. The first to
 file generic company's 180 day exclusivity also must be expired.
     Now, consumers will be able to compare their favorite retailer's brand of
 loratadine to Claritin and see the two medicines are exactly the same but one
 costs a lot less. A 30- day supply of Leiner's private label loratadine could
 retail for as little as $9.00, well below the combined $20-$30 co-pay the
 patient would have pay for the prescription and the doctor's visit," said
 Bensussen.
     "These lower prices consumers will see for loratadine refutes drug company
 claims that Rx to OTC switches burden consumers with higher out of pocket
 costs and ultimately reduce patient access to needed medication. This just
 isn't true," added Bensussen.
     Fair drug competition gives consumers self-care choices at a range of
 affordable prices and reduces overall healthcare costs for insurers.  The
 average American feels confident treating minor medical problems with over the
 counter drugs. In fact, a recent study conducted by the Consumer Healthcare
 Products Association indicated that 74% of people who take prescription drugs
 would prefer an OTC version. Branded and private label sales of loratadine
 combined are expected to exceed $700 million revealing consumers' appetite for
 Rx to OTC switches will continue to grow.
     Priced 80% less than prescription drugs, OTCs are a good deal for
 everyone. According to Mintel's Consumer Intelligence report, in 2000 OTC
 medicines saved the country $10.5 billion in healthcare costs that would have
 been spent on prescription drugs, doctor visits, and lost time from work.
 
     Background on Leiner Health Products
     Leiner Health Products, headquartered in Carson, Calif., is America's
 largest private label manufacturer of vitamins, minerals and supplements and
 the nation's second largest private label manufacturer of over the counter
 (OTC) prescription drugs. Leiner provides the nation's leading retailers with
 more than 3,000 private label products and markets its own brand of vitamins
 under YourLife(R) and OTCs under Pharmacist's Formula(R).
 
 

SOURCE  Leiner Health Products