Amneal Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials

Rhea-AI Summary

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for Propofol Injectable Emulsion USP in single-dose vials. Propofol, an essential surgical anesthetic, is currently on the ASHP drug shortages list. Amneal plans to manufacture the product in-house on a dedicated line to ensure consistent supply, with a launch expected in Q4 2024.

The approval covers three dosage strengths: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL. This complex emulsion injectable expands Amneal's portfolio and addresses supply chain constraints. According to IQVIA®, U.S. annual sales for propofol were approximately $314 million for the 12 months ended June 2024.

Positive

• FDA approval received for Propofol Injectable Emulsion USP
• Addresses chronic shortage of essential surgical anesthetic
• In-house manufacturing on dedicated line ensures consistent supply
• Expands Amneal's complex injectables portfolio
• U.S. annual sales for propofol were approximately $314 million

Negative

• Product launch not expected until Q4 2024
• Potential competition in a market with existing supply chain constraints

Financial Analyst

Amneal's FDA approval for Propofol Injectable Emulsion is a significant development for the company's injectables portfolio. With annual U.S. sales of $314 million for propofol, this represents a substantial market opportunity. The planned Q4 2024 launch could positively impact Amneal's revenue stream. However, investors should note that the market is competitive and Amneal's market share capture remains uncertain. The in-house manufacturing on a dedicated line is a strategic move to ensure consistent supply, potentially giving Amneal an edge in addressing the chronic shortage issue. This approval aligns with Amneal's focus on complex generics, which typically have higher margins and less competition.

Medical Research Analyst

The FDA approval of Amneal's Propofol Injectable Emulsion is crucial for addressing the chronic shortage of this essential anesthetic. Propofol's presence on the ASHP drug shortages list underscores the critical need for reliable suppliers. Amneal's entry into this market could help stabilize supply chains and improve patient care in surgical settings. The single-dose vial format is particularly important for reducing waste and improving dosage accuracy. However, it's worth noting that propofol's contraindications for patients with hypersensitivity to egg or soybean could limit its use in certain populations. Overall, this approval is likely to be well-received by healthcare providers struggling with anesthetic shortages.

Market Research Analyst

Amneal's strategic move into the propofol market demonstrates its commitment to expanding its complex generics portfolio. The chronic shortage of propofol presents a unique market opportunity for Amneal to establish itself as a reliable supplier. By manufacturing in-house, Amneal is positioning itself to potentially capture a significant market share. The company's focus on addressing drug shortages could enhance its reputation among healthcare providers and potentially lead to preferred supplier status. However, investors should be aware that the full impact on Amneal's financials won't be seen until after the Q4 2024 launch. The success of this product will depend on Amneal's ability to efficiently manufacture and distribute propofol while maintaining competitive pricing.

Propofol is an essential surgical anesthetic in hospitals that is in chronic shortage

Complex emulsion injectable expands Amneal’s injectables portfolio

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: 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 Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials.

Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists (ASHP) drug shortages list. Propofol has a history of shortage due to supply chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. The Company expects to launch propofol in the fourth quarter of 2024.

“Amneal is keenly focused on delivering critical drugs that are in short supply,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “This single dose formulation of propofol is an essential medicine utilized every day by hospitals for surgical use. We are proud to provide our hospital customers with this hard-to-make product and help patients in need. With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol.”

Propofol is contraindicated in people who have known hypersensitivity to propofol, egg or soybean. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for propofol for the 12 months ended June 2024 were approximately $314 million.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals 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 information, 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, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, 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, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other 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, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; 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; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; 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 claims brought against us by 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 Food and Drug Administration 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; 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 potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; 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/20240820807066/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What product did Amneal Pharmaceuticals (AMRX) receive FDA approval for?

Amneal Pharmaceuticals (AMRX) received FDA approval for Propofol Injectable Emulsion USP in single-dose vials, an essential surgical anesthetic used in hospitals.

When does Amneal (AMRX) plan to launch Propofol Injectable Emulsion?

Amneal (AMRX) plans to launch Propofol Injectable Emulsion in the fourth quarter of 2024.

What are the dosage strengths of Amneal's (AMRX) approved Propofol Injectable Emulsion?

The FDA approval covers three dosage strengths: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL single-dose vials.

What were the U.S. annual sales for propofol according to IQVIA® data mentioned in Amneal's (AMRX) press release?

According to IQVIA®, U.S. annual sales for propofol were approximately $314 million for the 12 months ended June 2024.

How does Amneal (AMRX) plan to address supply chain constraints for Propofol?

Amneal (AMRX) plans to manufacture Propofol in-house on a dedicated line to provide consistent supply and address chronic shortages.