AstraZeneca isn’t waiting for the FDA to answer its citizen petition to block Crestor generics. With time short before the arrival of a slew of cheap rivals to its big-selling statin, the company has sued the agency, asserting that a new orphan drug approval should give Crestor 7 more years without new generic competition.

Billions of dollars in sales are at stake for AstraZeneca, which collected $5 billion from Crestor last year, about 21% of the company’s overall revenue. The U.K.-based drugmaker is scrambling to pump up sales of its more recently launched meds, on its way to an ambitious goal of $45 billion in sales by 2023. More Crestor generics means a bigger hole in that brand’s sales--and a bigger gap for AstraZeneca to fill.

At issue in AstraZeneca’s suit are FDA labeling rules on generic drugs. Other brands with orphan drug approvals--and the market exclusivity those approvals confer--have seen generics hit the market in spite of that supposed exclusivity. The copycat meds simply bear labels that leave out information about the orphan approval.

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AstraZeneca and its partner IPR Pharmaceuticals say that labeling approach isn’t legal. It violates the agency’s own rules on including pediatric information in drug product labels, among other things, the drugmakers’ legal complaint contends.

Japan’s Otsuka Pharmaceuticals advanced a similar argument on its blockbuster antipsychotic Abilify, first petitioning the FDA to block generics, and then resorting to a court battle. Last May, it lost, and Abilify copies flooded the market as expected.

But AstraZeneca says that May 2015 court opinion--set out in this memorandum cited by FDA Law Blog--is wrong. In that opinion, the court essentially upheld the FDA’s Abilify decision and the reasoning behind it, but AstraZeneca argues that the agency’s interpretation of labeling rules violates the Administrative Procedures Act, and that it contradicts an earlier case involving generic versions of the diabetes drug Glucophage.

AstraZeneca is hoping to get an answer from the court before new Crestor generics are due to win final approval July 8. The company is demanding that the court nix the FDA’s current interpretation of the rules--and block those new generic approvals until May 2023.

Allergan’s generics-focused unit Watson Pharmaceuticals already sells one Crestor generic, but that’s allowed under a patent settlement between the two companies.

The company says it plans to work with the FDA on an expedited schedule for the case, but if the agency refuses, AstraZeneca plans to file for a temporary restraining order while the legal argument is pending.

In its citizen petition at the FDA, AstraZeneca also brought up another issue: It alleged that leaving out that pediatric data created safety risks. As FDA Law Blog points out, that argument isn’t included in the lawsuit, but the company intends to add it if the FDA goes ahead and approves the new generics without that orphan disease labeling.

Evercore ISI analyst Umer Raffat recently charted brand and generic Crestor script numbers since the copycat launched May 1, and the trend lines show the generic quickly gaining market share--and Crestor losing it--but those changes leveled off early this month, with Crestor’s brand scripts at just over 200,000 and the generic’s at just over 150,000.

Those trend lines would change dramatically if follow-up generics launch as currently expected. Pricing competition in generics tends to ramp up quickly as multiple copycat products make their debut, and that puts a quick squeeze on the original brand.

Meanwhile, AstraZeneca is doing what it can to a., retrench in the face of the Crestor generics threat, and b., boost brand sales as much as it can. Earlier this year, the drugmaker unveiled a $1.5 billion restructuring plan designed to save $1.1 billion annually; it includes sales and administrative cutbacks, and continued “streamlining” of its manufacturing network. The company is also promoting a co-pay assistance program that limits the costs of a Crestor prescription to $3 per 30-day supply for 12 months, for eligible patients.

- get AstraZeneca and IPR’s legal complaint

- see the FDA Law Blog post



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