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Viatris has received notice that an applicant submitted an abbreviated new drug application (“ANDA”) seeking FDA approval for a generic to Tyrvaya® (varenicline solution) Nasal Spray, with Paragraph IV certifications to the six patents currently listed in FDA’s Orange Book. Viatris is confident in the strength of its Tyrvaya® patent portfolio and intends to enforce its legal rights with respect to those patents, which all have expiration dates in October 2035.
This statement includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements that Viatris is confident in the strength of its Tyrvaya® patent portfolio and intends to enforce its legal rights with respect to those patents, which all have expiration dates in October 2035, and about the outcome of litigation. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that Viatris is unable to or unsuccessful in its efforts to enforce its Tyrvaya® patent rights; the possibility that Tyrvaya® could lose patent exclusivity or otherwise face generic competition sooner than October 2035 and experience a substantial loss of sales upon generic entry; the possibility that the Tyrvaya® patents could be invalidated in whole or in part or found to not be infringed, or that a generic applicant is not enjoined until the expiration of the patents, or any other adverse litigation outcome; the possibility that a competitor could launch a generic product “at risk” before the conclusion of patent litigation; the possibility of a litigation settlement that permits generic entry prior to the expiration dates of the Tyrvya® patents; the possibility that the Company may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with acquisitions, divestitures, or its global restructuring program, within the expected timeframe or at all; impairment charges or other losses related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by COVID-19; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.