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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.
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