Amneal Receives U.S. FDA Approval for Potassium Phosphates Injection IV Bags

Rhea-AI Summary

Amneal Pharmaceuticals (Nasdaq: AMRX) has received FDA approval for its potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags. This is the first preservative-free presentation of potassium phosphates in a single-dose IV infusion bag. It's Amneal's third 505(b)(2) injectable launch in 2024, following PEMRYDI RTU® and FOCINVEZ®. The product is indicated to correct hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement isn't possible. It's latex-free and can be stored at room temperature. Amneal plans to launch the product in Q3 2024, expanding its injectables portfolio with this differentiated offering for hospitals.

Positive

• FDA approval for new potassium phosphates IV bag presentation
• First preservative-free potassium phosphates in single-dose IV infusion bag
• Third 505(b)(2) injectable launch in 2024
• Product can be stored at room temperature, improving convenience
• Expands Amneal's injectables portfolio with a differentiated offering

Negative

• Potential adverse effects include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia

Pharmaceutical Industry Analyst

Amneal Pharmaceuticals' FDA approval for Potassium Phosphates Injection IV Bags represents a significant advancement in injectable drug delivery. This product's unique features, including its preservative-free formulation and room temperature storage capability, address key clinical needs and potentially streamline hospital pharmacy operations.

The approval marks Amneal's third 505(b)(2) injectable launch in 2024, following PEMRYDI RTU® and FOCINVEZ®. This strategic focus on value-added presentations demonstrates Amneal's commitment to expanding its complex generics portfolio, which could enhance its market position and revenue streams. The 505(b)(2) pathway allows for faster approvals while maintaining patent protection, potentially leading to higher profit margins compared to traditional generics.

From an investor perspective, this approval signals Amneal's growing capabilities in developing complex products, which could translate to improved competitive advantage in the highly saturated generics market. The company's ability to consistently bring innovative products to market may positively impact its financial performance and attract investor interest in the medium to long term.

However, investors should also consider potential challenges such as market adoption rates and pricing pressures in the hospital sector. The success of this product will depend on Amneal's ability to effectively market its benefits and secure favorable contracts with healthcare providers.

Healthcare Operations Expert

The introduction of Amneal's Potassium Phosphates Injection in ready-to-use IV bags represents a significant operational improvement for hospital pharmacies. The preservative-free, room-temperature stable formulation addresses several key pain points in clinical settings:

• Reduced compounding steps, potentially decreasing medication errors and improving workflow efficiency
• Room temperature storage, simplifying inventory management and reducing cold chain logistics costs
• Single-dose infusion bags, minimizing waste and improving dose accuracy

These features collectively contribute to enhanced patient safety and operational efficiency. For hospitals grappling with staffing shortages and cost pressures, such innovations can lead to meaningful time and cost savings.

However, the adoption of new products in hospital settings often faces hurdles such as existing supply contracts, staff training requirements and formulary review processes. Amneal's success will depend on effectively demonstrating the product's value proposition to hospital decision-makers and navigating these institutional barriers.

Overall, this approval aligns with the broader healthcare trend towards ready-to-use medications, which is reshaping hospital pharmacy practices and driving efficiencies across the healthcare system.

First presentation of preservative-free potassium phosphates in a single-dose IV infusion bag

Third 505(b)(2) injectable added this year – will launch in third quarter

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags. This sterile presentation reduces the compounding steps for clinicians typically required with administering the product.

Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. The product is available as a single-dose infusion bag and is formulated without preservatives. It is natural rubber latex-free and can be stored at room temperature.

In 2024, Amneal has already launched PEMRYDI RTU^®, a ready-to-use formulation of pemetrexed, and FOCINVEZ^®, a ready-to-use version of fosaprepitant. Both products offer hospitals and oncology clinics new, value-added presentations that should improve pharmacy efficiency by eliminating preparation steps. The expected third quarter launch of potassium phosphates injection IV bag represents the Company’s third 505(b)(2) launch this year.

“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “This new IV parenteral infusion bag is preservative-free and can be stored at room temperature. With the addition of new 505(b)(2) injectables, we are meaningfully expanding our injectables portfolio.”

"Our third 505(b)(2) injectable product approval this year reflects our deep capabilities in developing new and impactful complex products. We look forward to bringing more innovative 505(b)(2) injectable products to market over the coming years," said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Generics.

Adverse effects reported for the potassium phosphates injection IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia. For full prescribing information, see package insert located here.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, 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.

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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.

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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, including recent events affecting the financial services industry; 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/20240729345025/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the new product Amneal (AMRX) received FDA approval for?

Amneal received FDA approval for potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags, a preservative-free presentation in a single-dose IV infusion bag.

When will Amneal (AMRX) launch the new potassium phosphates IV bag?

Amneal plans to launch the new potassium phosphates IV bag in the third quarter of 2024.

What is the indication for Amneal's (AMRX) new potassium phosphates injection?

The product is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients weighing 40 kg or more when oral or enteral replacement is not possible, insufficient, or contraindicated.

How many 505(b)(2) injectable products has Amneal (AMRX) launched in 2024?

The potassium phosphates injection IV bag represents Amneal's third 505(b)(2) injectable launch in 2024, following PEMRYDI RTU® and FOCINVEZ®.