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22 March 2022AmericasMuireann Bolger

Takeda, Arbor aim to stop Turkish copies of high blood pressure drug

Takeda Pharmaceutical and Arbor Pharmaceuticals are seeking to block Turkey-based EastPharma from releasing a  generic version of  the blockbuster high blood pressure medication, Edarbi (azilsartan).

The companies lodged a lawsuit at the US District Court for the District of Delaware on March 18 in a civil action for the infringement of US patent numbers:157,584, 7,572,920 and 9,066,936.

Takeda licences to Azurity-owned Arbor for the drug, and the complaint is directed to EastPharma's Saba Ilac Sanayi ve Ticaret.

NovaQuest Capital’s  Azurity Pharmaceuticals acquired Arbor in a deal that finalised back in October.

Azilsartan is an angiotensin II receptor antagonist used in the treatment of hypertension, developed by Takeda. It is marketed by Arbor in tablet form under the brand name Edarbi.

The patents-in-suit are listed in the US Food and Drug Adminstration’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as covering Edarbi or its use.

According to the lawsuit, EastPharma’s subsidiary intends to market, sell, and/or distribute generics of Edrabi that are the subject of Abbreviated New Drug Application (ANDA) number 216699.

According to Takeda, it received written notification of the ANDA and its accompanying certification in February.

This letter contained an offer of confidential access (OCA) to certain confidential information regarding the generic. Takeda sent a proposed markup of the OCA in an attempt to reach agreement on the terms for confidential access, but EastPharma rejected this proposal and did not provide a counterproposal.

As of the filing of the complaint last week, the parties have not been able to reach an agreement, Takeda and Arbor have confirmed.

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