DUBLIN, Aug. 11, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Posaconazole Delayed-Release Tablets, 100mg. Allergan's ANDA product is a generic version of Merck's Noxafil® which is an antifungal agent indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high-risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplantation recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
Merck Sharp & Dohme Corp. filed suit against Allergan on August 6, 2015 in the U.S. District Court for the District of New Jersey seeking to prevent Allergan from commercializing its ANDA product prior to the expiration of U.S. Patent No. 5,661,151. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months from the date the plaintiffs received notice of Allergan's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Allergan believes it may be a "first applicant" to file an ANDA for the generic version of Noxafil® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending June 30, 2015, Noxafil® had global sales of approximately $143.6 million, according to IMS Health data.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the risks associated with acquisition transactions; the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 (such periodic public filings having been filed under the "Actavis plc" name) and from time to time in Allergan's other investor communications . Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Noxafil® is a registered trademark of Merck Sharp & Dohme Corp.
SOURCE Allergan plc