UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported):
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events
On October 27, 2023, Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, Inc. and Theravance Biopharma Ireland Limited, subsidiaries of the Registrant Theravance Biopharma, Inc. (together, “Theravance”), and Mylan Ireland Limited and Mylan Specialty L.P. (together, “Mylan”), entered into a Settlement Agreement (the “Settlement Agreement”) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (together, “Teva”, and together with Theravance and Mylan, the “parties”) relating to Theravance and Mylan’s YUPELRI® (revefenacin) inhalation solution. A Theravance entity owns and Mylan is the exclusive sub-licensee of Orange Book-listed United States Patent Nos. 8,541,451; 9,765,028; 10,550,081; 11,008,289; 11,484,531; and 11,691,948 (the “Orange Book Listed Patents”).
The Settlement Agreement resolves ongoing patent litigation brought by Theravance and Mylan against Teva pursuant to the Hatch-Waxman Act based on Teva’s filing of an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of YUPELRI® (revefenacin) inhalation solution prior to expiration of the Orange Book Listed Patents.
Under the Settlement Agreement, Theravance and Mylan granted Teva a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Teva’s generic version of YUPELRI® (revefenacin) inhalation solution in the United States on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
As required by law, the settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
The patent litigation previously disclosed by the Company against the other six ANDA filers, Accord Healthcare, Inc.; Cipla Limited; Eugia Pharma Specialities Ltd.; Lupin Inc.; Mankind Pharma Ltd.; and Orbicular Pharmaceutical Technologies Private Limited, along with certain affiliates, remains pending.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| THERAVANCE BIOPHARMA, INC. | ||
| Date: October 30, 2023 | By: |
/s/ Brett Grimaud |
| Brett Grimaud | ||
| General Counsel | ||
Cover |
Oct. 27, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Oct. 27, 2023 |
| Entity File Number | 001-36033 |
| Entity Registrant Name | THERAVANCE BIOPHARMA, INC. |
| Entity Central Index Key | 0001583107 |
| Entity Tax Identification Number | 98-1226628 |
| Entity Incorporation, State or Country Code | E9 |
| Entity Address, Address Line One | PO Box 309 |
| Entity Address, Address Line Two | Ugland House, South Church Street |
| Entity Address, City or Town | George Town, Grand Cayman |
| Entity Address, Country | KY |
| Entity Address, Postal Zip Code | KY1-1104 |
| City Area Code | 650 |
| Local Phone Number | 808-6000 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Ordinary Share $0.00001 Par Value |
| Trading Symbol | TBPH |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
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