Court Rules Against AstraZeneca on Scope of Drug Exclusivity

By Robyn Hagan Cain on April 29, 2013 | Last updated on March 21, 2019

When the FDA approves a pharmaceutical manufacturer’s New Drug Application application, the Federal Food, Drug, and Cosmetic Act (FDCA) entitles the manufacturer to a period of marketing exclusivity during which the FDA cannot approve bioequivalent generics. Once the exclusivity period has expired, the FDA can approve generic drugs bioequivalent to the pioneer drug through an abbreviated new drug application.

But there’s a way for drug manufacturers to extend their marketing exclusivity period: The FDCA provides for additional periods of exclusivity for pioneer drug through an abbreviated new drug application (ANDA).

If a supplement to an application (sNDA) contains reports of new clinical investigations essential to the approval of the supplement -- and conducted or sponsored by the person submitting the supplement -- the FDA cannot approve an ANDA for three years following the approval of an sNDA if the ANDA relies on information in the sNDA.

Got that?

This regulatory alphabet soup matters this week because D.C. Circuit Court of Appeals recently affirmed a decision to deny AstraZeneca a prolonged exclusivity period for Seroquel, an antipsychotic drug. The manufacturer had hoped to get an extended exclusivity period based on clinical data the company submitted to strengthen its warning label regarding the drug's effect on blood-glucose levels, Reuters reports. The FDA, however, denied the request, leading to this litigation.

Both the district court and the D.C. Circuit deferred to the FDA, and found that the label modification -- while based on clinical data -- was not entitled to exclusivity. The appellate court agreed that it was "coincidental" that the FDA approved the blood-glucose label change when approving the new pediatric uses for the drug.

Scott Lassman, a food and drug law specialist at Kleinfeld Kaplan & Becker, told Reuters, "I have seen cases where people argue over the scope of the exclusivity. This is a helpful ruling to clarify what FDA's thinking is."

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