US appeals court reinstates pause on generic version of Novartis' Entresto

Published 01/16/2025, 04:07 PM
Updated 01/16/2025, 05:56 PM
© Reuters. FILE PHOTO: The company's logo is seen at a building of Swiss drugmaker Novartis in Rotkreuz, Switzerland, January 29, 2020. REUTERS/Arnd Wiegmann/File Photo
NOVN
-

By Blake Brittain

WASHINGTON -Novartis won an order from a U.S. appeals court in Washington on Thursday temporarily blocking drugmaker MSN Pharmaceuticals from launching a generic version of Novartis (SIX:NOVN)' blockbuster heart-failure drug Entresto.

The U.S. Court of Appeals for the Federal Circuit ordered MSN not to launch its drug while it considers Novartis' request for a longer ban on the generic version.

The decision marks the latest change in fortune for Novartis amid multiple eleventh-hour bids to block MSN's generic, which Novartis said MSN could launch as early as Thursday.

The Federal Circuit's ruling comes hours after the U.S. Court of Appeals for the District of Columbia Circuit lifted a similar pause on the launch that had gone into effect Wednesday night.

Spokespeople and an attorney for Novartis did not immediately respond to requests for comment and more information on the rulings. An attorney for MSN declined to comment.

India-based MSN's version of Entresto was approved by the U.S. Food and Drug Administration last year. Novartis sued MSN and others seeking to launch Entresto generics for patent infringement.

Entresto is Switzerland-based Novartis' best-selling drug, which brought the company more than $6 billion in revenue in 2023.

The Federal Circuit last week reversed a 2023 decision that invalidated one of the patents. Novartis argued in a court filing that the ruling maintained the company's exclusive rights to sell Entresto until July.

© Reuters. FILE PHOTO: The company's logo is seen at a building of Swiss drugmaker Novartis in Rotkreuz, Switzerland, January 29, 2020. REUTERS/Arnd Wiegmann/File Photo

The company said MSN was preparing to launch its generic on Thursday, the day Novartis' patent expired.

U.S. district courts in Washington and Delaware rejected Novartis' requests on Wednesday for a mandate that would immediately block the generic.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2025 - Fusion Media Limited. All Rights Reserved.