Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics
26 Julho 2023 - 9:00AM
Business Wire
- Represents three high-value medicines across complex dosage
forms
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced it has submitted Abbreviated New Drug
Applications (“ANDA”) to the U.S. Food and Drug Administration
(FDA) for three key complex generic products, including:
Product
Dosage Category
U.S. IQVIA sales (TTM May 2023)
1
Albuterol sulfate inhalation
Inhalation
$814 million
2
Bimatoprost ophthalmic solution, 0.01%
Ophthalmic
$779 million
3
Propofol emulsion
Injectable
$311 million
“We continue to make excellent progress advancing our pipeline
of complex, high-value medicines. The filing of applications for
three new complex generics are additional proof points in our
successful innovation journey. Today, about 90% of our generics
R&D pipeline is made up of complex products. As we move up the
value chain of product complexity, we are adding new and
sustainable long-term growth drivers to our diversified portfolio,”
said Chirag and Chintu Patel, Co-Chief Executive Officers.
Injectable propofol emulsion, the generic version of Diprivan®,
is an IV general anesthetic and sedation drug. Amneal plans to
manufacture propofol emulsion internally by leveraging the
Company’s global injectables infrastructure. Bimatoprost ophthalmic
solution, the generic version of Lumigan®, is indicated for the
reduction of elevated intraocular pressure in patients with open
angle glaucoma or ocular hypertension. Albuterol sulfate
inhalation, the generic version of Proair® HFA, is indicated for
the treatment or prevention of bronchospasm related to
exercise-induced or reversible obstructive airway disease. All
trademarks are the property of their respective owners.
About Amneal Amneal Pharmaceuticals, Inc. (NYSE: 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 approximately 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
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forward-looking statements include statements regarding
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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
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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 bank
failures; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230726946342/en/
Investor Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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