On Wednesday, the FDA approved Sun Pharma, Glenmark and Aurobindo’s generic versions of London-based Astrazeneca’s best-selling cholesterol pill Crestor. AstraZeneca, however, argued any generics approved for the drug’s more typical use would thus carry incomplete product labels and should be blocked from the market.
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The FDA asked USA district judge Randolph Moss to dismiss the suit, and Par Pharmaceuticals Inc., Apotex Corp., Sandoz Inc. and other generic-drug makers intervened in the case. The ruling opens Crestor to broader competition, barring an appeal. Other Indian firms with tentative approvals for generic Crestor are Torrent Pharmaceuticals Ltd. and Alkem Laboratories Ltd. Queries asking whether these companies have also received final approvals via e-mail and telephone were not immediately returned. That move was loudly opposed by consumer advocates and members of Congress.
AstraZeneca’s bid to extend its exclusivity had drawn sharp criticism from former presidential candidate and Senator Bernie Sanders, a Democrat from Vermont, who along with seven Democratic U.S. Representatives had urged the U.S. Food and Drug Administration in a July 7 letter not to let the company exploit a “loophole”.
Moss’s decision on Tuesday is in line with a ruling a year ago by another judge in the same court, who allowed generic versions of Otsuka’s antipsychotic drug Abilify to go on the market even though the drug had recently been approved for a rare disease.
An AstraZeneca spokeswoman told Bloomberg that the company was “disappointed” and would evaluate its options.
Washington/London: AstraZeneca Plc can’t stop generic-drug makers from bringing cheaper rivals of its best-selling medicine, the cholesterol fighter Crestor, to the USA market. The first copycat version of Crestor is already on the market from Allergan Plc’s Watson Pharmaceuticals after a settlement in a patent infringement suit gave the manufacturer sole rights to start selling its version in early May.
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Sales of the name-brand drug are likely to plunge 30% to $3.5 billion this year as cheaper alternatives become available, according to analyst estimates compiled by Bloomberg. The rare genetic disease, which causes high cholesterol and sometimes heart disease, affects about one in a million people.
