Par Seeks to Keep Amneal from Bringing Generic Versions of Life-Saving Injection to Market

Par Pharmaceutical, Inc. and three of its subsidiaries filed a patent infringement suit on Monday against generic competitor Amneal EU, Ltd., and several of its foreign and domestic corporate relatives. The complaint alleges that two Abbreviated New Drug Applications (ANDAs) filed by Amneal infringe on Par’s United States Patent No. 10,844,435 (the ’435 patent) for Vasotrict, a drug used to treat dangerous drops in the blood pressure of critical care patients.

The filing explains that Par purchased the company who received Food and Drug Administration (FDA) approval for a vasopressin injection, now branded as Vasostrict, in 2014. Par asserts that since then, it has invested in research to make the drug safer and more effective. For example, the filing details how Par undertook a genetic study, the results of which have caused it to seek FDA approval for changes and updates to Vasostrict’s labeling and instructions.

Par contends that in March 2019, Amneal submitted two ANDAs for a single and a multi-dose proposed generic vasopressin injection, seeking to bring them to market prior to expiration of the operative patent. The filing states that they are currently under FDA review.

According to the plaintiff, FDA regulations will require Amneal to amend its proposed labeling for its biosimilar products if Par’s request to update and amend Vasostrict’s labeling is approved. If this comes to fruition, Par argues that Amneal’s products are “likely to include specific instructions directing physicians and other medical professionals to use the product to treat patients with AA or AT genotypes in accordance with the methods claimed in the ’435 Patent, thereby inducing direct infringement of the ’435 Patent.”

Par also claims that, notwithstanding approval of its proposed amendment and update, Amneal will still induce infringement because physicians will treat patients based on the most recent clinical information available, including Par’s discovery. Thus, the plaintiff contends, “any launch” of Amneal’s proposed products before its patent’s expiration would cause Par to suffer “immediate and irreparable harm.”

Par brings four counts of patent infringement seeking to prevent Amneal from bringing its drug to market before Par’s patent exclusivity period ends. The complaint requests injunctive and declaratory relief, as well as damages, should Amneal prevail in bringing its generics to market.

Par is represented by Dechert LLP.