Endo Launches First and Only Generic Version of Chantix® (varenicline) Tablets in the United States
Endo International announced that Par Pharmaceutical has begun shipping the first FDA-approved generic version of Pfizer's Chantix (varenicline) in the U.S. This significant milestone follows the final approval of its Abbreviated New Drug Application. Estimated sales of Chantix were approximately $1 billion for the 12 months ending June 30, 2021. Jon Holden, Endo's Senior VP, emphasized the importance of this launch in expanding Par's product portfolio and providing reliable generics to the market.
- Launch of the first FDA-approved generic version of Chantix, expanding product portfolio.
- Access to a market worth approximately $1 billion in annual sales for Chantix.
- None.
DUBLIN, Sept. 22, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping the generic version of Pfizer's Chantix® (varenicline), 0.5 mg and 1 mg tablets, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application.
Par's varenicline is the first and currently the only available FDA-approved generic version of Chantix® in the U.S.
"This important approval brings the first Chantix® generic to the U.S. market," said Jon Holden, Senior Vice President and General Manager, Generics at Endo. "As a reliable, quality supplier, Par is proud to help people during this critical time while also expanding our product portfolio."
According to IQVIA™, Chantix® tablet sales were approximately
Chantix® is a registered trademark of Pfizer Inc.
About Endo International plc
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
About Par Pharmaceutical, Inc.
Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par Pharmaceutical is an Endo company. Learn more at www.parpharm.com.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Holden and any statements relating to product launch and product sales. All forward-looking statements in this press release reflect Endo's current expectations of future events based on information available to Endo as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections, including with respect to the impact of any litigation, investigation or settlement proceeding on our financial statements, including our cash flows from operations; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our ability to maintain compliance with our financial obligations under certain of our outstanding debt obligations, causing a downgrade of our debt and long-term corporate ratings (which could increase our cost of capital) and exposing us to potential events of default (if not cured or waived) under financial and operating covenants contained in our or our subsidiaries' outstanding indebtedness; our ability to incur additional borrowings under the covenants in our then-existing facilities or to obtain additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes, or to refinance our indebtedness; and/or a significant reduction in our short-term and long-term revenues and/or otherwise cause us to be unable to fund our operations and liquidity needs, such as future capital expenditures and payment of our indebtedness. The occurrence or possibility of any such result may cause us to pursue one or more significant corporate transactions or remedial measures, including on a preventative or proactive basis. Actions that may be evaluated or pursued could include reorganization or restructuring activities of all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. Some of these measures could take significant time to implement and others may require judicial or other third party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Other risks and uncertainties include general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.
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SOURCE Endo International plc
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