Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) has received FDA approval for two products and one tentative approval: memantine/donepezil extended-release capsules for Alzheimer's dementia treatment (with 180-day exclusivity), everolimus tablets for treating Tuberous Sclerosis Complex, and tentative approval for rifaximin tablets for IBS-D treatment.

The memantine/donepezil product references Abbvie's NAMZARIC®, everolimus references Novartis' AFINITOR DISPERZ®, and rifaximin references Bausch Health's XIFAXAN®. The U.S. market size for these products (as of November 2024) is approximately $88 million for memantine/donepezil, $114 million for everolimus, and $2.6 billion for rifaximin (all indications).

Positive

• Secured 180-day exclusivity for memantine/donepezil extended-release capsules
• Entering market with combined annual sales potential of $2.8 billion
• Expanding portfolio in high-value therapeutic areas (Alzheimer's, oncology, gastrointestinal)
• Everolimus approval addresses supplier market

Negative

• Rifaximin approval is tentative due to ongoing litigation
• Common adverse reactions reported for all three products

Insights

Pharmaceutical Industry Analyst

The FDA approvals represent a significant strategic win for Amneal, particularly in high-value complex generics. The 180-day exclusivity for memantine/donepezil ($88 million market) provides a important first-mover advantage, potentially capturing 50-60% of the market during the exclusivity period. This translates to an estimated $20-25 million in revenue opportunity for the first half of 2025.

The everolimus approval is strategically important due to competition in the $114 million market. By increasing supply in a constrained market, Amneal can potentially secure a stable market share while addressing critical oncology needs. The supplier landscape typically allows for better price stability and higher margins compared to commoditized generics.

The tentative approval for rifaximin targets the largest opportunity at $2.6 billion, though pending litigation adds uncertainty to the launch timeline. The IBS-D indication represents a growing market segment and Amneal's preparation positions them well for eventual commercialization. However, investors should note that litigation outcomes could significantly impact the timing and market opportunity.

These approvals align with Amneal's strategic focus on complex generics, which typically face less competition and offer higher margins than traditional generics. The company's ability to execute in challenging formulations (extended-release, oral suspensions) demonstrates strong R&D capabilities and positions them well for future complex generic opportunities.

Approval of three important therapies for dementia, oncology and gastrointestinal disease

Granted 180-day exclusivity for memantine/donepezil extended-release capsules

Tentative approval of rifaximin, a product for treating IBS-D

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC^®, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFINITOR DISPERZ^®. In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which references Bausch Health’s XIFAXAN^®. The FDA approval was tentative as this product is involved in litigation.

Memantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product has launched with 180-day exclusivity.

Everolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older. This launch increases the supply of an oncology product that has limited suppliers.

Rifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

“Amneal’s competitive advantage in the Affordable Medicines business remains our core capabilities to drive innovation at scale across complex categories to expand the breadth and depth of our portfolio,” said Andy Boyer, Executive Vice President, Chief Commercial Officer, Affordable Medicines. “With our 180-day exclusivity on memantine/donepezil, increasing supply for everolimus, and the tentative approval of rifaximin, we are continuing to expand our differentiated portfolio and providing new key therapies for our customers, providers and patients.”

The most common adverse reactions with memantine hydrochloride were headache, diarrhea, and dizziness. The most common adverse reactions occurring in patients receiving donepezil include diarrhea, anorexia, vomiting, nausea, and bruising. For complete prescribing information, see package insert available here.

The most common adverse reactions with everolimus tablets in patients treated for TSC-Associated SEGA: are stomatitis and respiratory tract infection. For complete prescribing information, see package insert available here.

According to IQVIA^®, U.S. annual sales for memantine/donepezil tablets, everolimus tablets and rifaximin tablets for the 12 months ended November 2024 were approximately $88 million, $114 million, and $2.6 billion (for all approved indications of XIFAXAN^®), respectively.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical 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 Affordable Medicines 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.

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 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. 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/20250123740756/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the market size for Amneal's (AMRX) newly approved memantine/donepezil product?

According to IQVIA data, the U.S. annual sales for memantine/donepezil tablets were approximately $88 million for the 12 months ended November 2024.

What is the significance of AMRX's 180-day exclusivity for memantine/donepezil?

The 180-day exclusivity gives Amneal a temporary monopoly as the only generic manufacturer of this Alzheimer's treatment, potentially leading to significant market share and revenue during this period.

Why did AMRX receive only tentative approval for rifaximin?

The FDA granted tentative approval for rifaximin due to ongoing litigation related to the product.

What is the market opportunity for AMRX's rifaximin product?

The U.S. annual sales for rifaximin tablets were approximately $2.6 billion for all approved indications, according to IQVIA data for the 12 months ended November 2024.

What conditions will AMRX's everolimus tablets treat?

Everolimus tablets are approved for treating Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older.