AstraZeneca Sues FDA, Seeks to Bar Crestor Copies Until 2023

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By Dana A. Elfin

June 28 — AstraZeneca Pharmaceuticals is suing the FDA to prevent the agency from approving generics of its cholesterol treatment Crestor in July ( AstraZeneca Pharmaceuticals LP v. Burwell, D.D.C., 1:16-cv-01336, complaint filed 6/27/16 ).

The suit asks the court to permanently enjoin the FDA from approving any generic Crestor products before May 27, 2023, when AstraZeneca’s seven-year orphan drug exclusivity period on a rare-disease use expires. The company filed suit in the U.S. District Court for the District of Columbia on June 27.

Crestor (rosuvastatin calcium) is set to lose market exclusivity July 8 when a six-month period of pediatric exclusivity on Crestor's main compound patent expires. That means that the Food and Drug Administration could approve additional generics of Crestor as soon as July, a development that AstraZeneca would like to keep from happening.

Currently, there are several abbreviated new drug applications (ANDAs) for generic Crestor awaiting approval at the FDA.

With the possibility of agency approval of those generic applications looming, AstraZeneca is asking the court to expedite proceedings in the case.

It's also asking the court to bar the FDA from approving any generic Crestor applications until its lawsuit against the agency is resolved.

Huge Financial Impact Predicted

AstraZeneca says the financial consequences stemming from the FDA approving Crestor generics would be devastating. If the FDA is allowed to approve the pending applications, “additional generic manufacturers would immediately flood the market with low-cost rosuvastatin calcium—thereby dramatically eroding Crestor’s market share and causing AstraZeneca to sustain substantial and immediate revenue losses,” the complaint said.

“Because manufacturers typically ship several months’ worth of generic drugs immediately upon FDA approval, AstraZeneca would be unable to recoup its market position and lost revenues even if it ultimately prevails” in the litigation, the company complaint said.

Bloomberg Gadfly health-care columnist Max Nisen agreed with AstraZeneca's assessment. The financial repercussions of multiple generic versions of Crestor entering the market are likely to be “big and quick,” Nisen told Bloomberg BNA June 28.

Indeed, Crestor has been a blockbuster product for AstraZeneca, with global sales totaling $5 billion in 2015.

In 2016, Nisen said, the consensus is that Crestor global sales will drop to $3.5 billion, a 30 percent drop-off in revenue.

“AstraZeneca's lawsuit makes sense,” Nisen said, both because of the huge drop-off in revenue that's expected to occur as soon as multiple Crestor generics start to enter the market and because of the FDA's continuing efforts to reduce the backlog of generic drug applications at the agency.

FDA Lacks Authority

At the heart of AstraZeneca's suit is the intersection between pediatric labeling for generic drugs and a manufacturer's orphan drug exclusivity rights.

Under the Orphan Drug Act of 1983, the FDA can award seven years of marketing exclusivity to reward companies for developing drugs to treat rare conditions and diseases. Rare or “orphan” diseases are defined as those that affect 200,000 or fewer Americans.

In its suit, AstraZeneca says that the FDA doesn't have the authority to approve generic applications for Crestor until 2023, because of orphan drug exclusivity the FDA granted to the company on Crestor for a rare pediatric genetic disorder called Homozygous Familial Hypercholesterolemia (HoFH).

Michele L. Meixell, head of external and executive communications at AstraZeneca Pharmaceuticals LP in Wilmington, Del., told Bloomberg BNA in a June 28 e-mail that, as a result of the orphan drug status for HoFH, “AstraZeneca believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the U.S.”

Abilify Case

AstraZeneca also asks the court to set aside the agency's 2015 interpretation of federal food and drug law as allowing the agency to approve “carved-out” generic versions of exclusivity-protected drugs.

Specifically, AstraZeneca says the agency acted outside of its authority when it approved generic versions of Japanese drugmaker Otsuka Pharmaceutical Co.'s schizophrenia treatment Abilify (aripiprazole).

In the case of Abilify, the FDA interpreted the law to allow it to approve generic versions of the drug as long as the generic drug manufacturer omitted or carved out from its label Otsuka’s exclusivity-protected indication for treating Tourette’s syndrome in children.

A federal district court later upheld the agency's actions and said that they were based on a reasonable interpretation of the governing statute and were owed deference (13 PLIR 802, 6/5/15).

AstraZeneca argues that the decision was incorrect and should be overturned.

Will AstraZeneca Succeed?

Terry G. Mahn, an attorney with Fish & Richardson P.C. in Washington, who is an expert in patent and exclusivity matters, said he's not convinced that AstraZeneca's lawsuit will succeed.

“I think this is a long shot,” Mahn told Bloomberg BNA in a June 28 email. “AstraZeneca is trying to ‘turn back the hands of time' to 2001. Back then, FDA policies were clear that pediatric labeling was mandatory and could not be overridden by the ‘carve out' rules.”

Since then, times have changed, he said. “Congress took action with the Best Pharmaceuticals for Children Act,; labeling policies have gradually evolved; and FDA has gained a great deal of experience addressing carve out challenges of all kinds,” Mahn said. Indeed, he said, the FDA's decision in the generic Abilify matter in 2015 “is a culmination of some of these experiences.”

Despite the fact that one district court has upheld the FDA's approval action in the Abilify matter, “AstraZeneca is banking on another district court saying just the opposite—that FDA has acted unreasonably or arbitrarily and that a single protected pediatric use should be able to stop generic approval of any and all other uses on the brand label,” Mahn said.

“AstraZeneca has an uphill fight,” Mahn said, particularly in view of the trends in this area.

“With very few exceptions, FDA always seems to find a way of allowing patent and exclusivity ‘carve outs' by generic entrants,” he said. “It may be unfair to brands who invest considerable resources to develop new uses for old drugs that can then be circumvented by the ever expanding carve out rules, but that seems to be where we are.”

In addition, he said, “Courts generally don't like to overturn agency decisions that attempt to fill in obvious holes left by Congress—especially when it comes to the lowering of health care costs.”

If AstraZeneca wins this case, Mahn said, it will be over a technicality in the law.

Earlier Citizen Petition

AstraZeneca's suit follows on the heels of a citizen petition the company filed June 13 seeking similar relief on Crestor (14 PLIR 891, 6/17/16).

Although the citizen petition addresses the exclusivity issues AstraZeneca raises in the lawsuit, AstraZeneca filed its suit “[b]ecause the FDA is not expected to rule on AstraZeneca’s citizen petition before Crestor's loss of exclusivity,” Meixell said.

The petition also raises separate safety and efficacy issues that AstraZeneca's lawsuit doesn't address.

Licensed Generic on Market

Meanwhile, there is already one generic version of Crestor on the market. Watson Laboratories Inc. (now part of Actavis Inc.) began to market a generic version of Crestor May 2 under the terms of a license AstraZeneca granted to it under a 2013 patent litigation settlement.

AstraZeneca is based in the U.K. Co-plaintiff iPR Pharmaceuticals Inc. is located in Puerto Rico and is an affiliate of AstraZeneca, according to the complaint. That company, iPR, owns the new drug application (NDA) for Crestor and the supplemental NDA for the use of Crestor to treat pediatric patients 7 to 17 years of age with HoFH.

Covington & Burling LLP in Washington and EngelNovitt PLLC in Washington represent AstraZeneca and iPR.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

A copy of the complaint is available at

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