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AstraZeneca fails to keep generic Crestor rivals off market

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(Bloomberg) — AstraZeneca can’t stop generic-drug makers from bringing cheaper rivals of its best-selling medicine, the cholesterol fighter Crestor, to the U.S. market.

A federal judge in Washington, D.C., refused the company’s request for a temporary ban on the generics Tuesday and, barring an appeal, his ruling means generic drugmakers may now enter the market for a drug that generated more than $5 billion in global sales for London-based AstraZeneca last year.

Sales of the name-brand drug are likely to plunge 30 percent to $3.5 billion this year as cheaper alternatives become available, according to analyst estimates compiled by Bloomberg.

Related: Crestor developer sees sales doubling on lower-priced drugs

Losing revenue from its top-selling drug would be the latest blow to the company, which has already seen sales tumble as patents expire on some of its leading medicines. Chief Executive Officer Pascal Soriot, who spurned Pfizer’s takeover offer two years ago, warned this year that profit and sales would continue to drop, partly because of Crestor, which contributed a fifth of the company’s revenue.

Drug exclusivity

“We are disappointed in the decision and evaluating our options,” Michele Meixell, a spokeswoman for AstraZeneca said in an e-mail. Sandy Walsh, a spokeswoman for the U.S. Food and Drug Administration, declined to comment on the ruling.

The company sued the FDA last month after the regulator said it could market the drug exclusively for seven years as a treatment for a rare form of pediatric high-cholesterol. However, generic versions could be sold as soon as this month with that pediatric use omitted from their labels.

AstraZeneca said such a decision would immediately flood the market with competitors, “eviscerating” its right to market Crestor as a so-called orphan drug, one used to treat rare conditions. The company also claimed the FDA violated its own rules requiring generic drugs to have the same labeling as their name-brand counterparts.

The FDA asked U.S. District Judge Randolph Moss to dismiss the suit, and Par Pharmaceuticals, Apotex Corp., Sandoz and other generic-drug makers intervened in the case. The companies argued that preventing cheaper forms of Crestor would be contrary to public interest.

The first copycat version of Crestor is already on the market, from Allergan’s Watson Pharmaceuticals after a settlement in a patent infringement suit gave the manufacturer sole rights to start selling its version in early May, 67 days before the exclusivity ended on July 8.

AstraZeneca sought a temporary court order to block the FDA from allowing more generics from entering the market until there was a final decision on its argument that it’s entitled to exclusivity because of the pediatric indication.

The case is AstraZeneca Pharmaceuticals LP v. Burwell, 16-cv-1336, U.S. District Court, District of Columbia (Washington).

Related: Amgen cholesterol drug wins U.S. approval for some patients

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