AstraZeneca files Hail Mary petition urging FDA to block more Crestor generics till 2023

Crestor card

AstraZeneca faces just one generic version of its blockbuster statin med Crestor. And the U.K. drug giant wants to keep it that way.

The company has filed a citizen petition with the FDA contending that the agency can’t approve more generics because it granted Crestor a new indication in late May--one that likely comes with a pediatric orphan drug exclusivity that would last till May 2023.

The petition sets out a series of legal reasons why the FDA can’t “carve out” that exclusive indication and approve generics for the rest of Crestor’s list of uses. If the agency buys its argument, AstraZeneca and Watson Pharmaceuticals, a subsidiary of Allergan, could keep the rosuvastatin market to themselves.

That, in turn, could protect a bigger chunk of AstraZeneca’s $5 billion in brand sales, which accounted for 21% of its 2015 top line. When other blockbuster meds have gone off patent, their revenues have dropped somewhat when competing with just one generic version, but plummet after multiple copycats hit the market.

Watson rolled out its rosuvastatin med May 2 under a patent settlement with AstraZeneca forged back in 2013. The Allergan generics unit is set to join Teva Pharmaceutical Industries under a $20 billion sale expected to close this month.

The FDA Law Blog details AstraZeneca’s legal argument, which differs from that in another carve-out case--over generic versions of Spectrum Pharmaceuticals’ Fusilev. A U.S. Circuit Court panel sided with Novartis’ Sandoz unit earlier this month in that case, the blog notes, allowing the generics maker to roll out its version despite the fact that its official label lacked information about an orphan indication in colorectal cancer.

In addition to a several other points we’ll leave to the expert blog, AstraZeneca’s petition cites a previous FDA decision against Otsuka Pharmaceuticals, which was trying to protect its big-selling antipsychotic drug Abilify. 

“Unlike Abilify, Crestor meets all three of the Policy’s criteria and is therefore entitled to de facto exclusivity for the duration of AstraZeneca’s seven-year period of orphan drug exclusivity,” says AstraZeneca.

The drug giant is pushing the FDA to move quickly on its petition, because the pediatric exclusivity on Crestor expires July 8, opening the door for other generics to be approved. The FDA has tentatively OK’d several companies’ applications, including one that could vie with Watson for 180-day exclusivity despite its patent deal with AstraZeneca, the blog notes.

The stakes are high for AstraZeneca, which has been working to build up sales of newer meds and bulk up its pipeline in anticipation of Crestor’s patent cliff. Earlier this year, the drugmaker unveiled a $1.5 billion restructuring plan to retrench in the face of Crestor generics. The plan, designed to save $1.1 billion annually, 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. 

- see the FDA Law Blog post
- check out the AZ petition

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