Eagle Pharma launches new suit over leukaemia drug
Oncology specialist seeks to block another bendamustine generic following trio of lawsuits in January | Firm filed complaint for patent infringement against Dr Reddy’s.
Eagle Pharmaceuticals has moved to block another generic version of its cancer drug Belrapzo, through a patent infringement lawsuit against Indian multinational Dr Reddy’s Laboratories in New Jersey.
In the complaint, filed in the federal court on Friday last week (February 2), Eagle sought to assert two newly granted patents covering its bendamustine hydrochloride injection, used to treat patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma.
Eagle alleged in January that three other pharmaceutical companies— Slayback Pharma, Apotex and Baxter Healthcare—had infringed the same patents with their proposed generics to Belrapzo.
New patents relied on to block generics
The patents-in-suit, US patent numbers 11,844,783 and 11,872,214, were granted in November 2023 and January of this year, respectively.
Both are titled “Formulations of Bendamustine”, referring to an alkylating drug given as an injection to cancer patients. Eagle said its Belrapzo injection fell within the scope of the patents.
Dr Reddy’s notified Eagle on December 19, 2023 that it was seeking US Food and Drug Administration (FDA) approval for a new drug application (NDA) for bendamustine hydrochloride, according to the complaint.
This would be used to treat the same types of cancer as Belrapzo, and had the same active ingredient and stability as the product, Eagle claimed.
The New Jersey-based firm asked the federal court for a judgment of infringement, a preliminary and permanent injunction preventing the sale of Dr Reddy’s NDA product, and a damages award.
According to the company website, Eagle’s Belrapzo and Bendeka products, both bendamustine injections, accounted for around 88% share of the bendamustine US market in the second quarter of 2023.
In April last year, Eagle reached a settlement with Dr Reddy’s related to another NDA referencing Bendeka, having asserted Orange Book-listed patents against it.
Under the confidential deal, Dr Reddy’s could market its product from November 2027 or earlier under certain circumstances.
Trio of lawsuits
On January 17 this year, Eagle filed complaints against Slayback Pharma, Apotex and Baxter Healthcare, over NDAs those firms launched in 2022 for bendamustine hydrochloride.
The next day, the oncology specialist published a statement saying that it sought lost profits and damages from the alleged infringements and injunctive relief until the expiration of the patents in 2031.
Michael Graves, interim principal executive officer and interim executive chairman of Eagle, said: “We are pleased to maximise our intellectual property for the bendamustine franchise and will continue to take appropriate steps to enforce our rights related to the newly issued patents.”
The case filed last week is Eagle Pharmaceuticals v Dr Reddy’s Laboratories. Eagle is represented by McCarter & English and Latham & Watkins.
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