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Amneal & PL Developments Launch Store Brand Program of Over-the-Counter (“OTC”) Diclofenac Sodium Topical Gel, 1%

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Amneal Pharmaceuticals (NYSE: AMRX) and PL Developments have begun shipping store brand equivalent Voltaren® Arthritis Pain Gel (diclofenac sodium topical gel, 1%) in various sizes after receiving FDA clearance. This product, previously available only by prescription, is significant for US consumers. The original Voltaren® Arthritis Pain generated approximately $250 million in sales prior to its switch to OTC in February 2020. This collaboration aims to enhance the availability of affordable generic medicines, demonstrating Amneal's commitment to accessible healthcare.

Positive
  • Launch of store brand equivalent Voltaren® Arthritis Pain Gel enhances product portfolio.
  • FDA clearance for the product supports market entry.
  • History of successfully launching Voltaren Gel in 2016 indicates strong market positioning.
Negative
  • Potential risks associated with market competition in the OTC segment.
  • Dependence on the sales performance of a newly launched product.

BRIDGEWATER, N.J.--()--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal’ or the “Company”) and PL Developments (PLD) today announced that they have commenced shipments of store brand equivalent Voltaren® Arthritis Pain Gel (diclofenac sodium topical gel, 1%) in 50, 100 and 150g laminate tubes following FDA clearance. Amneal and PLD have partnered to bring this important product to US retailers.

Voltaren® Arthritis Pain was switched OTC in February of 2020, making it available to US consumers without a prescription. Prior to switching OTC, sales of diclofenac sodium topical gel, 1% totaled approximately $250 million.

“We, along with our partners at PLD, are excited to announce the launch of the first brand matching portfolio of store brand Voltaren® OTC,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “We were the first to market generic Voltaren Gel in 2016 and are pleased to launch an OTC version. This represents another example of Amneal’s commitment to bringing affordable generic medicines to US consumers.”

Mitch Singer, CEO of PL Developments, said, “We are thrilled to expand our product partnership with Amneal. By working together, we are able to bring the first truly brand matching portfolio of store brand Voltaren® OTC to US retailers. This successful launch continues our commitment to bringing valuable and affordable products to our retail partners and to US consumers.”

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.

About PLD

Founded in 1988, PL Developments is a top manufacturer, packager and distributor of store-brand OTC pharmaceutical and consumer healthcare products. PLD is a U.S. based manufacturer, packager and distributor of pharmaceutical products, with a focus on serving US retailers in their store brands. Operating 7 sites and offering more than 300 unique products across various dosage forms and therapeutic categories, PLD is a leading supply of over the counter pharmaceutical products. For more information, visit www.pldevelopments.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.

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 Amneal. A list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.

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, except as otherwise required by United States securities laws.

Contacts

Tasos Konidaris
EVP, Chief Financial Officer
invest@amneal.com

FAQ

What recent announcement did Amneal Pharmaceuticals make regarding Voltaren®?

Amneal Pharmaceuticals announced the launch of store brand equivalent Voltaren® Arthritis Pain Gel after FDA clearance.

What is the significance of the Voltaren® launch for Amneal (AMRX)?

The launch represents a strategic expansion of Amneal's product portfolio and commitment to affordable healthcare.

What were the sales figures for Voltaren® before it became OTC?

Voltaren® generated approximately $250 million in sales prior to its switch to over-the-counter status in February 2020.

When did Voltaren® switch to over-the-counter availability?

Voltaren® was switched to over-the-counter availability in February 2020.

What is the product formulation of the new Voltaren® Arthritis Pain Gel?

The new Voltaren® Arthritis Pain Gel is available in 1% diclofenac sodium topical gel format.

Amneal Pharmaceuticals, Inc.

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Drug Manufacturers - Specialty & Generic
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