AstraZeneca Files Citizen’s Petition To Defend Entry of a Generic Version of Crestor

AstraZeneca has filed a Citizen Petition with the US Food and Drug Administration (FDA) requesting that the agency not approve any abbreviated new drug application or new drug application referencing the company’s anti-cholesterol drug, Crestor (rosuvastatin calcium), until the expiration of the pediatric orphan drug exclusivity in 2023. The move is part of a generic defense strategy for Crestor, which was AstraZeneca’s top-selling drug in 2015 with sales of $5.02 billion.

The substance patent protecting Crestor in the US expired on January 8, 2016 and the existing pediatric exclusivity period expires on July 8, 2016. Actavis (now part of Allergan) is permitted to begin selling generic rosuvastatin in the US in May 2016 as the result of a litigation settlement with AstraZeneca. 

On May 27, 2016, the FDA approved Crestor for treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to treat low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein-cholesterol, and apolipoprotein B as an adjunct to diet, either alone or with other lipid-lowering treatments. Previously, on February 14, 2014, FDA's Office of Orphan Products Development granted AstraZeneca Orphan Drug Designation for Crestor in the treatment of pediatric HoFH.

AstraZeneca applied for orphan designation for Crestor for the treatment of pediatric HoFH in November 2013. FDA granted that designation on February 14, 2014. In its Citizen’s Petition, AstraZeneca asserts that the FDA's approval of the pediatric HoFH sNDA thus triggers a grant of seven years of orphan exclusivity to the new labeling, extending from May 27, 2016, to May 27, 2023.

Crestor was first approved for marketing in the Netherlands on November 6, 2002. In the United States, Crestor was approved for use in adult patients with dyslipidemia, including HoFH, on August 12, 2003. In 2013, AstraZeneca executed an settlement agreement with Watson Laboratories, Inc. (later acquired by Actavis, which is now part of Allergan; Allergan is in the process of divesting its generics business to Teva Pharmaceutical Industries) that granted Watson the ability to market generic rosuvastatin beginning on May 2, 2016. Watson began marketing its generic rosuvastatin product on or about May 2, 2016, and has continued to market that product through the date of AstraZeneca’s Citizen Petition. As required under the terms of the March 2013 settlement agreement, AstraZeneca has granted Watson a patent license and a selective waiver of all periods of exclusivity applicable to FDA's May 27, 2016, approval of the pediatric HoFH indication and labeling with respect to Watson's marketing of its generic rosuvastatin product.

Source: FDA and AstraZeneca (Citizen Petition) 

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