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Will Claritin Continue to Reign Supreme?
Nov. 16, 1999 (Washington) -- A recent Capitol Hill debate over extending the patent of Schering-Plough's antihistamine Claritin (loratadine) could have prompted an allergic reaction in someone previously unexposed to federal regulatory language and "intellectual property" jargon.
Representatives from Claritin's maker, Schering-Plough; makers of generic drugs -- cheaper versions of brand-name drugs that are sold after the brand-name products' patents expire; and consumer groups clashed as the Senate Judiciary Committee held a hearing on legislation sponsored by Robert Torricelli (D, N.J.) and Jeff Sessions (R, Ala.). If passed, it would extend Claritin's patent for three more years -- thus granting Claritin three more years of market exclusivity. House lawmakers have introduced a similar bill.
The main question the lawmakers clashed over was one of perspective: Would the legislation provide an unjustified financial advantage for the makers of a highly profitable drug -- or would it be fair treatment for a firm burdened by FDA delays?
As almost everyone knows, Claritin has been a multimillion-dollar cash cow, with sales of almost $2 billion just last year. But it is slated to lose patent protection in 2002 -- and generic-drug manufacturers are eager to begin making and selling their cheaper versions of it. Schering-Plough is arguing to have its Claritin patent extended and hold off the generic drug makers, on the basis that although Schering-Plough received its patent for Claritin in 1981, the antihistamine was under FDA "approval review" for more than 5 years afterwards. As a result, it didn't hit the market until 1993.
The firm's CEO, Richard Kogan, testified at the hearing that because of the FDA's delay, Claritin will have had only about 9 years of market exclusivity, even though, on average, new prescription drugs enjoy more than 12 years of patent protection. "Claritin received the worst of both worlds -- extraordinarily lengthy regulatory review and minimum patent restoration," he said.
Claritin is a "pipeline" drug, meaning that it was under FDA review in 1984 when Congress passed the landmark "Hatch-Waxman" drug-patent legislation. "Pipeline" drugs received a less generous patent extension allowance than drugs that were not yet under review in 1984.
Seven other "pipeline" drugs would be included under the provisions of the Torricelli-Sessions bill: Relafen (nabumetone), Daypro (oxaprozin), Cardiogen-82 (rubidium), Dermatop (prednicarbate), Eulexin (flutamide), Nimotop (nimodipine), and Penetrex (enoxacin).
But various consumer interests, represented at the hearing by retired Sen. Howard Metzenbaum (D, Ohio), argued that extending the patents will cost consumers billions of dollars, since generic drugs are dramatically less costly than the brand-name products. According to an industry-funded study from the University of Minnesota's Pharmaceutical Research in Management & Economics Institute, just a 3-year Claritin extension would cost patients $5.3 billion through 2007. Extensions to the other drugs would add billions more.
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