Amneal launches 4 new Generic products, including Vasopressin single-dose

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for four generic products, expanding its essential medicines portfolio. The approved products include vasopressin injection, famotidine for oral suspension, atropine sulfate ophthalmic solution, and clindamycin phosphate topical gel. Together, these products represent a market potential of approximately $784 million. Amneal aims to launch 20-30 generics annually, with this latest approval bringing their year-to-date launches to 16. This strategic move is expected to enhance their position in the generics market.

Positive

• Received FDA approval for four generic products, enhancing product offerings.
• Total market potential for new approvals is approximately $784 million.
• On track to meet annual target of 20-30 generics launches.

Negative

• None.

- Brings year-to-date generics launches to 16; on-track for 20-30 this year

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- 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 four generics products, including vasopressin injection 1mL (single-dose).

The four recently approved products include:

		Product	Dosage Category	U.S. TTM IQVIA sales (June 2022)
1		Vasopressin injection 1mL	Injectable	$624 million
2		Famotidine for oral suspension (40 mg/5 mL)	Oral Liquid	$96 million
3		Atropine sulfate 1% ophthalmic solution	Ophthalmic	$35 million
4		Clindamycin phosphate topical gel USP, 1% (75 mL)	Topical	$29 million

Chirag and Chintu Patel, Co-Chief Executive Officers, stated, “We are pleased to add these four new products to our essential medicines portfolio. Most notably, Vasopressin expands our injectables portfolio and drives further scale in that business for us. Each year, we target 20 to 30 new product launches in generics, and we are on-track to achieving that goal again in 2022.”

Vasopressin injection 1mL is a generic version of the antidiuretic hormone Vasostrict®. For full prescribing information, see package insert located here.

Famotidine for oral suspension (40 mg/5 mL), an H2 antagonist, is a generic equivalent for Pepcid®. For full prescribing information, see package insert located here.

Atropine sulfate 1% ophthalmic solution, an anticholinergic, is a generic version of Atropine Sulfate Ophthalmic Solution, USP 1% (2 mL, 5 mL and 15 mL). For full prescribing information, see package insert located here.

Clindamycin phosphate topical gel USP, 1% (75 mL) is a generic version of Clindagel®. This product received Competitive Generic Therapy (CGT) approval designation as Amneal continues to have the highest number of CGT designated products in the industry. 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 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, strategies, 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, including pro forma results; impact of acquisitions and dispositions, and estimated returns or assumptions underlying acquisitions and dispositions; the Company’s strategy for growth; regulatory approvals and actions; market position, saturation, 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, including from brand and generic drug product companies, and the impact of that competition on our ability to execute on pricing strategies; our ability to obtain exclusive marketing rights for our products; 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; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or curb Amneal’s ability to sell its products; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; 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 and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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 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/20220811005562/en/

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What products did Amneal Pharmaceuticals receive FDA approval for?

Amneal received FDA approval for vasopressin injection, famotidine for oral suspension, atropine sulfate ophthalmic solution, and clindamycin phosphate topical gel.

What is the market potential of the recently approved products by Amneal?

The combined market potential of the recently approved products is approximately $784 million.

How many generic products has Amneal launched so far this year?

Amneal has launched 16 generic products year-to-date.

What is Amneal's target for new product launches in generics?

Amneal targets 20-30 new product launches in generics each year.