Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension

Rhea-AI Summary

Amneal Pharmaceuticals, Inc. (AMRX) has received approval and launched fluorometholone ophthalmic suspension, USP, 0.1%, with 180-day competitive generic therapy exclusivity from the FDA. The product is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. The company aims to drive continued growth with the launch of this high-value product in the less crowded and durable ophthalmic category. Adverse effects include short-term inflammatory eye reactions and long-term use effects such as elevation of intraocular pressure and possible development of glaucoma, optic nerve damage, cataract formation, vision problems, and delayed eye wound healing. The U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.

Insights

Pharmaceutical Market Analyst

The approval and launch of Amneal Pharmaceuticals' fluorometholone ophthalmic suspension, coupled with the 180-day competitive generic therapy (CGT) exclusivity, signifies a strategic foothold in the ophthalmic market. This exclusivity period can be a significant driver for Amneal's revenue growth, as it temporarily shields the product from generic competition, potentially allowing the company to establish market dominance.

Given that the U.S. annual sales for FML® stood at approximately $62 million, the introduction of a generic equivalent by Amneal could capture a substantial market share, assuming price competitiveness and effective distribution channels. The ophthalmic sector is known for its barriers to entry, including stringent regulatory requirements and the need for specialized manufacturing capabilities. Amneal's expansion in this area suggests a deliberate move to capitalize on less crowded therapeutic categories, which could lead to more sustainable long-term revenue compared to more contested generic drug markets.

Medical Research Analyst

Fluorometholone ophthalmic suspension's indication for corticosteroid-responsive inflammation represents an essential treatment option for patients. The drug's efficacy in managing inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe addresses a critical need within ophthalmology. However, the reported adverse drug events, such as the potential elevation of intraocular pressure leading to glaucoma, underscore the importance of monitoring and managing these risks in clinical practice.

From a medical research perspective, the balance between efficacy and safety profiles is paramount. While the generic introduction may improve patient access due to lower costs, healthcare providers must remain vigilant about the long-term use effects, which could lead to serious ophthalmic conditions. This vigilance could influence prescribing patterns and ultimately affect market adoption rates of the generic product.

Financial Analyst

The CGT exclusivity granted to Amneal Pharmaceuticals for its fluorometholone ophthalmic suspension is a critical element to consider from an investment standpoint. This exclusivity can be a catalyst for stock performance, particularly for a mid-size generic pharmaceutical company like Amneal. The ability to capitalize on this period without competition could lead to a favorable adjustment in earnings projections for the upcoming two quarters.

Investors should monitor Amneal's execution during this exclusivity window, including production scale-up and market penetration strategies. The company's success in leveraging this opportunity will be indicative of its operational efficiency and could provide insights into its potential to manage future product launches effectively. However, it is also essential to consider the potential impact once the exclusivity period expires and competitors enter the market, which could lead to price erosion and margin compression.

- Fluorometholone Ophthalmic Suspension, USP, 0.1%

- Product has 180-day competitive generic therapy exclusivity

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension. The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines.

FML^® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

“We are starting the new year with the launch of another complex high-value product, which will help drive our continued growth,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “Ophthalmic products represent a less crowded and more durable category, and we continue to expand our portfolio of affordable medicines.”

Adverse drug events reported with the use of fluorometholone ophthalmic suspension 0.1% include short term inflammatory eye reactions such as eye and eyelid swelling, redness, burning eye pain, itchy eyes; and long-term use effects including elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent optic nerve damage, cataract formation, vision problems, and delayed eye wound healing. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.

About Amneal

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 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.

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, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, 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 ability to manage our growth through acquisitions and otherwise; 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 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; 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 ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; 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 product liability and other claims against us by consumers and other 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 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 ability to attract, hire and retain highly skilled personnel; 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/20240110374733/en/

Investor

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the product launched by Amneal Pharmaceuticals, Inc. with 180-day competitive generic therapy exclusivity?

Amneal Pharmaceuticals, Inc. has launched fluorometholone ophthalmic suspension, USP, 0.1%.

What is the indication of FML suspension?

FML suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

What are the adverse effects reported with the use of fluorometholone ophthalmic suspension 0.1%?

Adverse effects include short-term inflammatory eye reactions and long-term use effects such as elevation of intraocular pressure, possible development of glaucoma, optic nerve damage, cataract formation, vision problems, and delayed eye wound healing.

What were the U.S. annual sales for FML for the 12 months ended November 2023?

The U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.