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Supernus sues Zydus again over generic Trokendi XR migraine, seizure drug

  • Zydus allegedly infringed patents with proposed Trokendi generic
  • Parties settled earlier patent dispute in 2017
  • Complaint says Zydus not allowed to make generic till 2023

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(Reuters) – Supernus Pharmaceuticals sued Indian generic drugmaker Zydus Cadila and its U.S. subsidiary in Manhattan federal courtroom on Friday for allegedly infringing 10 patents with its proposed generic of Supernus’ top-selling drug for migraines and seizures.

The corporations had settled earlier patent litigation over a proposed generic of Trokendi XR in 2017, and Supernus said the Friday lawsuit was triggered by Zydus’ new Abbreviated New Drug Application for U.S. Food and Drug Administration approval of its generic.

The criticism mentioned the events’ settlement does not enable Zydus to launch its generic till 2023. Supernus requested the courtroom to bar Zydus from making or promoting the generic earlier than its patents expire, and the longest-lasting Supernus patent at challenge expires in 2029.

Supernus and its attorneys Edgar Haug, Nicholas Giove, and Richard Kurz of Haug Partners did not instantly reply to a request for remark, nor did Zydus USA, a New Jersey-based subsidiary of Zydus Cadila.

Trokendi XR is Rockville, Maryland-based Supernus’ highest-selling drug, incomes it practically $320 million final fiscal yr and making up over half of its whole gross sales, in accordance with a press release.

An ANDA asserts that the related drug patents are invalid or wouldn’t be infringed by the generic, and opens the applicant to infringement claims from the patent proprietor. The criticism mentioned Zydus advised the FDA in August that Supernus’ Trokendi XR patents are invalid, however their agreement explicitly prohibits Zydus from difficult the validity of many of the patents.

The case is Supernus Pharmaceuticals Inc v. Zydus Pharmaceuticals (USA) Inc, U.S. District Court for the Southern District of New York, No. 1:21-cv-07795.

For Supernus: Edgar Haug, Nicholas Giove, and Richard Kurz of Haug Partners.

Read extra:

Supernus publicizes settlement with Zydus on Trokendi XR patent litigation

Blake Brittain

Blake Brittain stories on mental property regulation, together with patents, emblems, copyrights and commerce secrets and techniques. Reach him at blake.brittain@thomsonreuters.com

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