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July 20, 2016 at 08:33 AM
(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.
