Theravance Biopharma reaches patent settlement with Cipla on YUPELRI inhalation

Published 20/08/2025, 11:18
Theravance Biopharma reaches patent settlement with Cipla on YUPELRI inhalation

Theravance Biopharma, Inc. (NASDAQ:TBPH), a biopharmaceutical company with a market capitalization of approximately $676 million, reached a settlement agreement with Cipla (NSE:CIPL) Limited and Cipla USA, Inc. regarding ongoing patent litigation over YUPELRI (revefenacin) inhalation solution, according to a press release statement filed with the U.S. Securities and Exchange Commission. The company’s stock has shown strong momentum, trading near its 52-week high of $14.30.

The settlement, finalized Friday, also involves Mylan (NASDAQ:VTRS) Ireland Limited and Viatris Specialty L.P., who are parties to the YUPELRI patents. The agreement resolves litigation initiated under the Hatch-Waxman Act, which was based on Cipla’s submission of an abbreviated new drug application (ANDA) to market a generic version of YUPELRI prior to the expiration of certain U.S. patents held by Theravance and exclusively sub-licensed to Mylan.

Under the terms of the settlement, Theravance and Mylan have granted Cipla a royalty-free, non-exclusive, non-sublicensable, and non-transferable license to manufacture and market a generic version of YUPELRI in the United States beginning April 23, 2039. The agreement allows for certain customary exceptions.

The settlement remains subject to review by the U.S. Department of Justice and the Federal Trade Commission, as required by law.

Theravance stated that patent litigation concerning YUPELRI remains ongoing against another ANDA filer, Mankind Pharma Ltd. and its affiliates.

Theravance Biopharma is incorporated in the Cayman Islands and its ordinary shares are listed on the NASDAQ Global Market under the symbol TBPH. The information in this article is based on a press release statement filed with the SEC. InvestingPro analysis reveals the company has achieved a 64% return over the past year, with 15+ additional investment insights available to subscribers. For deeper analysis, access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Theravance Biopharma reported strong financial results for the second quarter of 2025, with earnings per share reaching $1.08, significantly surpassing the forecasted $0.67. Revenue also exceeded expectations, coming in at $26.2 million compared to the projected $15.92 million. These results marked a substantial surprise, with earnings and revenue beating estimates by 61.19% and 64.57%, respectively. Additionally, Theravance completed its Trelegy royalty sale for $225 million and received a $7.5 million milestone payment following the approval of Yupelri in China. In light of these developments, Leerink Partners raised its price target for Theravance Biopharma to $13.00 from $10.00, while maintaining a Market Perform rating. These recent developments indicate a positive trajectory for the company, as reflected in the financial results and analyst actions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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.