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Generic TrendsGenerics WillHave ModestNegative Impact onHypertension DrugMarket SalesThrough 2018Despite the generic erosionof many hypertensiondrug productsexpected over the nextdecade, it is estimatedthat the overall hypertensiondrug marketwill experience only amodest decline. Accordingto DecisionResources, a researchand advisory firm forpharmaceutical andhealth care issues, themarket will decrease1.4% annually through2013, and thereafter theannual decline will slowto 1% through 2018 inthe United States,France, Germany, Italy,Spain, the United Kingdom,and Japan.According to a companyreport, a majorcontributor to the marketdecline will be anincrease in the genericavailability of antihypertensiveagents. Forexample, by 2018,Novartis’s Diovan alonewill lose more than $1billion in sales beginningnext year when thedrug goes off patent.Other hypertensiondrug classes will sufferas well, includingangiotensin-convertingenzyme inhibitors (ACEinhibitors), angiotensinII receptor antagonists,Hatch-Waxman Act Turns 25Twenty-five years ago a bill introduced by Senator Orrin Hatch and Rep.Henry Waxman that would change the generic industry forever was signedinto law at a White House Rose Garden ceremony. While not perfect, theHatch-Waxman Act continues to receive accolades from industry observersand government officials.“Our industry is proud of how far it has come in the past 25 years,” saidKathleen Jaeger, president and CEO of the Generic Pharmaceutical Association,commenting on the law. “Today, generic medicines represent 72% ofthe total prescriptions dispensed in the U.S., but only 17% of all dollarsspent on prescription drugs. One billion dollars is saved every three days byusing generics. That’s extraordinary savings—far more than anyone predictedor could have even imagined 25 years ago.”Health and Human Services Secretary Kathleen Sebelius also offeredkudos, particularly in the context of health care reform proposals currentlyin front of Congress.“I think that it’s appropriate this year that as we look at what’s pendingin Congress on health reform that we are also celebrating the quarter centuryanniversary of the Hatch-Waxman Act, which really began to transformthe pharmaceutical industry and made generic drugs much morewidely available to Americans.”And from the bill’s authors comes admission that they didn’t always seeeye-to-eye from across the aisle, but were able to still produce a bipartisanpiece of legislation that has withstood many challenges over its relativelyshort 25-year history.“Henry and I put our differences aside to work in a bipartisan mannerto get the bill passed,” admits Senator Hatch. “In the end, we passed a billthat has not only worked well, but has saved consumers, state, and federalgovernments billions of dollars.”“When Senator Hatch and I developed the legislation 25 years ago toproduce generic drugs, we thought that the result of this law would saveperhaps a billion dollars…in reality generic drugs have saved consumer andbusinesses, and state and federal governments $734 billion,” said RepresentativeWaxman.calcium channel blockers,and diuretics.Mylan SettlesWith Pfizer OverVfend GenericMylan Pharmaceuticalsand Matrix Laboratorieshave entered into a settlementand licenseagreement with PfizerInc. relating to voriconazoletablets, 50 mg and200 mg, the generic versionof Pfizer’s VfendTablets, a triazole antifungalagent.Mylan’s Matrix wasthe first company tosubmit a substantiallycomplete AbbreviatedNew Drug Applicationcontaining a ParagraphIV certification to theFDA and thereforebelieves it will be eligiblefor 180 days of marketingexclusivity uponcommercial marketing ofthe product.Pursuant to the agreement,Mylan will havethe right to marketvoriconazole tablets inthe U.S. in the firstquarter of 2011.54U.S. Pharmacist • November 2009 • www.uspharmacist.com