- Company granted 180 days of exclusivity under FDA Competitive Generic Therapy (CGT) approval pathway
- Expects to begin commercialization activities March 1, 2021
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System. In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity.
Amneal’s Norelgestromin and Ethinyl Estradiol Transdermal System is the generic version of the reference listed drug (“RLD”) Ortho Evra® and will be marketed under the proprietary name Zafemy™. Zafemy is a 12.5 cm2 patch indicated for the prevention of pregnancy in women with a Body Mass Index of less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Zafemy may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg). The Company expects to begin commercialization activities on March 1, 2021.
“Today’s approval is a significant milestone for patients and our company,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Zafemy will provide patients with another option to the one equivalent product—Xulane®, manufactured by Mylan—currently on the market. It also demonstrates the continued successful execution of our strategy to develop and commercialize complex generics and represents the 10th of 15 high-value complex products we expect to launch before August 2021.”
According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Xulane® for the 12 months ended December 2020 were approximately $332 million.
“Zafemy is our fifth transdermal product approval and utilizes our extensive in-house expertise in Matrix-based as well as Hydrogel-based patches,” continued Mssrs. Patel. “We continue to focus our R&D capabilities as well as the power of our integrated supply chain on bringing more complex products to market faster and more cost-efficiently.”
The RLD Ortho Evra® has been discontinued, and according to the FDA announcement of discontinuation published in the Federal Register, the product was not discontinued or withdrawn for safety or efficacy reasons. Xulane® is the only other equivalent to Ortho Evra® currently available on the market.
The drug carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Zafemy is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC), the labeling says. Zafemy is also contraindicated for use in women with a Body Mass Index greater than 30 kg/m2. Women with a BMI greater than 30 kg/m2 may have a higher risk of venous thromboembolic events compared with women with a lower BMI.
The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. See Package Insert (PI) for full prescribing information including boxed warning: https://www.amneal.com/wpcontent/uploads/2021/02/ZAFEMY-PI-Rev-02-2021-03.pdf
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.
The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.
Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
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