Entresto: Novartis loses initial bid to block generic of blockbuster heart drug

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-14T11:30:28+05:30 | Updated On 14 Aug 2024 11:30 AM IST

London: Novartis, a leading pharmaceutical company, has failed in its attempt to convince a federal court to block MSN Pharmaceuticals, a generic drugmaker, from launching a generic version of Novartis' popular heart-failure medication, Entresto, as per a court decision issued.

U.S. District Judge Richard Andrews in Delaware ruled that Novartis' likelihood of winning its patent infringement lawsuit against MSN Pharmaceuticals was too low to justify a halt to the launch of the generic drug. However, Judge Andrews has temporarily prohibited MSN from selling the drug while Novartis appeals the decision to the U.S. Court of Appeals for the Federal Circuit.

Entresto is Switzerland-based Novartis' best-selling drug, earning the company more than $6 billion in revenue last year. MSN's version of Entresto was approved by the U.S. Food and Drug Administration last month and would be the first U.S. generic of the drug.

According to Reuters, Novartis said in a statement that it was "considering all available options" to defend its intellectual property and "maintains its financial guidance for 2024."

Spokespeople for MSN did not immediately respond to a request for comment on the decision.

Novartis sued MSN and others seeking to launch Entresto generics in 2022 for infringing a patent that expires in 2026. It asked the court on Aug. 2 for a preliminary injunction blocking MSN from launching its generic, which was approved by the FDA on July 24.

Andrews ruled on Monday that Novartis was not likely enough to win on its infringement claims to justify the injunction. The judge also rejected Novartis' argument that a ruling against the company would cause "irreparable harm" by triggering a wave of generic Entresto launches by other drugmakers.

Andrews placed a three-day hold on the case while Novartis appeals to the Federal Circuit.

Novartis has separately asked a Washington, D.C. district court to block MSN's launch as part of a challenge to the FDA's decision to approve the generic. The Washington court has not yet ruled on Novartis' request.

novartisnovartis newsMSN pharmaheart failure drugentrestopatent infringement

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751