Amneal launches 4 new Generic products, including Vasopressin single-dose
August 11 2022 - 4:05PM
Business Wire
- Brings year-to-date generics launches to 16; on-track for
20-30 this year
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced that it has received Abbreviated New
Drug Application (ANDA) approval from the U.S. Food and Drug
Administration (“FDA”) for four generics products, including
vasopressin injection 1mL (single-dose).
The four recently approved products include:
Product
Dosage Category
U.S. TTM IQVIA sales (June 2022)
1
Vasopressin injection 1mL
Injectable
$624 million
2
Famotidine for oral suspension (40 mg/5
mL)
Oral Liquid
$96 million
3
Atropine sulfate 1% ophthalmic
solution
Ophthalmic
$35 million
4
Clindamycin phosphate topical gel USP, 1%
(75 mL)
Topical
$29 million
Chirag and Chintu Patel, Co-Chief Executive Officers, stated,
“We are pleased to add these four new products to our essential
medicines portfolio. Most notably, Vasopressin expands our
injectables portfolio and drives further scale in that business for
us. Each year, we target 20 to 30 new product launches in generics,
and we are on-track to achieving that goal again in 2022.”
Vasopressin injection 1mL is a generic version of the
antidiuretic hormone Vasostrict®. For full prescribing information,
see package insert located here.
Famotidine for oral suspension (40 mg/5 mL), an H2 antagonist,
is a generic equivalent for Pepcid®. For full prescribing
information, see package insert located here.
Atropine sulfate 1% ophthalmic solution, an anticholinergic, is
a generic version of Atropine Sulfate Ophthalmic Solution, USP 1%
(2 mL, 5 mL and 15 mL). For full prescribing information, see
package insert located here.
Clindamycin phosphate topical gel USP, 1% (75 mL) is a generic
version of Clindagel®. This product received Competitive Generic
Therapy (CGT) approval designation as Amneal continues to have the
highest number of CGT designated products in the industry. For full
prescribing information, see package insert located here.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated essential medicines company.
We make healthy possible through the development, manufacturing,
and distribution of generic and specialty pharmaceuticals,
primarily within the United States. The Company has a diverse
portfolio of over 250 products in its Generics segment and is
expanding across a broad range of complex products and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceutical
products 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, 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
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forward-looking statements include statements regarding
management’s intentions, plans, strategies, beliefs, expectations
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research and development; discussions of future operations;
expected operating results and financial performance, including pro
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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 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 in general, including from
brand and generic drug product companies, and the impact of that
competition on our ability to execute on pricing strategies; our
ability to obtain exclusive marketing rights for our products; our
ability to manage our growth through acquisitions and otherwise;
our dependence on the sales of a limited number of products for a
substantial portion of our total revenues; the continuing trend of
consolidation of certain customer groups; our dependence on
third-party suppliers and distributors for raw materials for our
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disruptions; litigation outcomes, including intellectual property
disputes or other legal efforts to prevent or curb Amneal’s ability
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the ongoing COVID-19 pandemic; risks related to federal regulation
of arrangements between manufacturers of branded and generic
products; our reliance on certain licenses to proprietary
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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 FDA product approval requirements; the impact
of healthcare reform and changes in coverage and reimbursement
levels by governmental authorities and other third-party payers;
our dependence on third-party agreements for a portion of our
product offerings; the impact of global economic conditions,
including any economic effects stemming from adverse geopolitical
events, an economic downturn and inflation rates; our ability to
identify, make and integrate acquisitions or investments in
complementary businesses and products on advantageous terms; 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
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
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not to place undue reliance on any such forward-looking statements,
which speak only as of the date they are made. Forward-looking
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Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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