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14 February 2017Americas

AstraZeneca sues Dr Reddy's over breast cancer drug

AstraZeneca has filed a patent infringement claim against Dr Reddy's Laboratories over the drug Faslodex (fulvestrant) intramuscular injection, a treatment for breast cancer.  The case was filed on Friday, February 10 at the US District Court for the District of New Jersey. The dispute began when Dr Reddy's filed an Abbreviated New Drug Application (ANDA) seeking approval from the Food and Drug Administration to market a generic version of Faslodex before the expiration of AstraZeneca’s patents.  According to the claim, four patents are involved: US numbers 6,774,122; 7,456,160; 8,329,680; and 8,446,139.  In January, Dr Reddy’s notified AstraZeneca of the generic application, claiming that the patents involved were not valid, were unenforceable, and/or would not be infringed by the generic.  According to the complaint, the ANDA relies on the Faslodex New Drug Application and contains data that, according to AstraZeneca, demonstrates the bioequivalence of the proposed ANDA product and Faslodex. AstraZeneca has asked the court to enter a judgment that the four patents are valid and that the submission of the ANDA was an act of infringement.  It has also asked the court to permanently enjoin Dr Reddy's from bringing the generic drug to market, as well as for costs and expenses.

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More on this story

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29 April 2021   Amarin delayed the market entry of generic versions of the cardiovascular drug Vascepa by using supply agreements to halt competitors from accessing the drug’s active pharmaceutical ingredient, according to a new antitrust lawsuit.
Big Pharma
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More on this story

Big Pharma
2 March 2021   Los Angeles company Puma Biotechnology and Beijing-based CANBridge Pharmaceuticals have cancelled a 2018 licensing deal which gave the latter exclusive rights to a breast cancer drug in China.
Americas
29 April 2021   Amarin delayed the market entry of generic versions of the cardiovascular drug Vascepa by using supply agreements to halt competitors from accessing the drug’s active pharmaceutical ingredient, according to a new antitrust lawsuit.
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13 May 2021   India-based generics drug maker Dr. Reddy's Laboratories has entered into a voluntary licensing agreement with Eli Lilly to expand access to COVID-19 treatment in India.