Amneal Announces 26 Generic New Product Launches in 2022 and First Injection Large Volume Bag Approval

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) reported a successful year in 2022, launching 26 new generic products, with 8 in Q4 alone, including clindamycin phosphate gel and ipratropium bromide nasal sprays. The company received FDA approval for its first large volume bag product, esmolol hydrochloride in sodium chloride injection, expected to generate annual sales of $57 million. For 2023, Amneal anticipates over 30 new product launches, signaling ongoing innovation and growth in its injectables business.

Positive

• Launched 26 new generic products in 2022, including 8 in Q4.
• FDA approval for esmolol hydrochloride in sodium chloride injection expands product portfolio.
• Expected over 30 new product launches in 2023, indicating continued growth.

Negative

• None.

- 8 new product launches in Q4 closes out another successful year of innovation

- First approval of a large volume bag product signals further expansion of injectables business

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the Company has successfully launched 26 new generic products in 2022. In the fourth quarter of 2022, the Company launched 8 new generic products, including clindamycin phosphate gel 1%, ipratropium bromide nasal sprays, and prednisolone sodium phosphate oral solution.

“2022 was another successful year of innovation for Amneal. Across the portfolio we continue to innovate, further expand our portfolio of essential medicines, and drive incremental impact and benefit for health care professions and their patients. Looking to 2023, we expect more than 30 new product launches,” said Chirag Patel and Chintu Patel, Amneal Co-Chief Executive Officers.

In addition, Amneal also announced it received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration (“FDA”) for its first large volume bag, esmolol hydrochloride in sodium chloride injection.

Harsher Singh, SVP for Amneal Biosciences, stated, “We are seeing continued momentum in expanding our injectables business. We are excited about this first ready to use bag approval utilizing one of our new manufacturing sites and look forward to more over the coming months.”

Esmolol hydrochloride in sodium chloride injection is indicated for tachycardia. For full prescribing information, see package insert located here. According to IQVIA®, U.S. annual sales for this product for the 12 months ended October 2022 were $57 million.

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 over 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.

Cautionary Statement on 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: discussions of future operations; expected or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, 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, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; 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; 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 continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; 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; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, inflation and rising interest rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our obligations under a tax receivable agreement may be significant; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221220005028/en/

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What new products did Amneal Pharmaceuticals launch in 2022?

Amneal Pharmaceuticals launched 26 new generic products in 2022, including 8 in the fourth quarter.

What FDA approval did Amneal receive recently?

Amneal received FDA approval for its first large volume bag product, esmolol hydrochloride in sodium chloride injection.

What are Amneal Pharmaceuticals' projections for 2023 product launches?

Amneal Pharmaceuticals expects to launch more than 30 new products in 2023.

What is the estimated annual sales figure for esmolol hydrochloride?

The estimated annual sales for esmolol hydrochloride in sodium chloride injection are $57 million.

Where is Amneal Pharmaceuticals headquartered?

Amneal Pharmaceuticals is headquartered in Bridgewater, NJ.