• Company can’t stop copies of its $5 billion cholesterol pill
  • Federal judge denied request to temporarily block FDA ruling

AstraZeneca Plc 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.

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 Inc.’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. The company’s American depositary receipts rose 38 cents to $30.68 at 10:58 a.m. in New York.

Sandy Walsh, a spokeswoman for the U.S. Food and Drug Administration, said the agency has approved applications from eight companies for generic versions of Crestor, including Apotex Corp., Par Pharmaceutical Holdings Inc., Mylan NV and Teva Pharmaceutical Industries Ltd.

“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” Walsh said in a statement. “Generic drugs offer important options to patients who are managing chronic health conditions.”

AstraZeneca 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.

Public Interest

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, Apotex, Sandoz Inc. 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 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, 67 days before the exclusivity ended on July 8.

AstraZeneca sought a temporary court order to block the FDA from allowing more generics to enter 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).

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