– Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the approval of four generic injectables products. Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy (CGT) status by the FDA.
The Company has approximately 25 commercial injectables for the U.S. institutional market and is targeting over 40 launches from 2021 to 2025 in a variety of complex areas, such as drug/device combinations, peptides, long acting injectables and large volume parenteral (LVP) bags.
“An important element of Amneal’s long-term growth strategy is expanding our injectables business, and today’s announcement of four new approvals is another key step. We look to scale our injectables business through new products and by leveraging our recent Puniska and Saol baclofen franchise acquisitions towards our goal of being top five in the U.S. institutional injectables market and a global player over time,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “These four approvals, including two products currently on the FDA drug shortage list, demonstrate our commitment to the institutional market and to alleviating drug shortages so that patients can have access to the medicines they need,” said Harsher Singh, SVP for Amneal Biosciences.
Dexamethasone is a bioequivalent and therapeutically equivalent generic to the reference standard dexamethasone sodium phosphate injection, USP 10 mg/mL. This corticosteroid is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for dexamethasone injection for the 12 months ended December 2021 were $66 million.
For full prescribing information, see package insert located here.
Azactidine is the generic equivalent for Vidaza® Injection 100 mg. This antineoplastic drug is currently on the FDA drug shortage list. According to IQVIA®, U.S. annual sales for azacitidine injection for the 12 months ended December 2021 were $61 million.
For full prescribing information, see package insert located here.
Carboprost is a generic version of the prostaglandin Hemabate® Injection, 250 mcg/mL. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $57 million.
For full prescribing information, see package insert located here.
Atropine is an anticholinergic agent. It is a bioequivalent and therapeutically equivalent generic to the reference listed drug atropine sulfate injection, USP, 0.5 mg/5 mL in a pre-filled single-dose syringe. This product was granted CGT status. According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2021 were $1 million.
For full prescribing information, see package insert located here.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.
Forward-Looking Statements
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: product research and development; discussions of future operations; expected operating results and financial performance; the Company’s strategy for growth; 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: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies; the impact of global economic conditions; direct or indirect impacts of the ongoing COVID-19 pandemic; our ability to obtain exclusive marketing rights for our products; the impact of 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, make and integrate acquisitions 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 impact of severe weather. 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.
Contacts
Anthony DiMeo
Senior Director, Investor Relations
anthony.dimeo@amneal.com