Amneal Receives Abbreviated New Drug Application Approval for Acyclovir Cream, 5%

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for its Acyclovir Cream, 5%, a generic version of Zovirax® for treating recurrent cold sores in adults and adolescents. This product, which is available by prescription, is a noteworthy addition to Amneal's portfolio, representing a significant step in its strategy to provide accessible complex generics. The U.S. annual sales for Acyclovir Cream for the year ending September 2020 were around $67 million, highlighting its market potential.

Positive

• FDA approval for Acyclovir Cream, 5%, signaling growth in complex generic formulations.
• Potential market opportunity with annual sales of approximately $67 million for the product.

Negative

• None.

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) today announced that it has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Acyclovir Cream, 5%. Acyclovir Cream, 5%, is the generic version of Zovirax® for treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. The product is available by prescription only and is associated with mild side effects such as nausea.

“Approval of our Acyclovir Cream, 5%, marks another milestone along our path toward providing more accessible, complex generic formulations to patients and to the U.S. healthcare system,” stated Chirag and Chintu Patel, Co-Chief Executive Officers. “Acyclovir Cream, 5%, represents one of our complex drug products launched this year, which demonstrates the strength of our pipeline and the depth of our manufacturing capabilities. This approval is a precedent for Amneal as it is the first Topical Cream product to be approved based on innovative scientific strategy, which also demonstrates our technological advancements.”

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Acyclovir Cream, 5%, for the 12 months ended September 2020 were approximately $67 million.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, 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 Private Securities Litigation Reform Act of 1995, as amended). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.

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