- Launching Dexamethasone, Azacitidine, Carboprost, and Atropine
for the Institutional Market
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the approval of four generic injectables
products. Dexamethasone sodium phosphate injection, USP 10 mg/mL,
azacitidine 100 mg, carboprost tromethamine injection, USP 250
mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have
received Abbreviated New Drug Application (ANDA) approval from the
U.S. Food and Drug Administration (FDA). Dexamethasone and
azacitidine are both currently on the FDA drug shortage list, and
atroprine was granted Competitive Generic Therapy (CGT) status by
the FDA.
The Company has approximately 25 commercial injectables for the
U.S. institutional market and is targeting over 40 launches from
2021 to 2025 in a variety of complex areas, such as drug/device
combinations, peptides, long acting injectables and large volume
parenteral (LVP) bags.
“An important element of Amneal’s long-term growth strategy is
expanding our injectables business, and today’s announcement of
four new approvals is another key step. We look to scale our
injectables business through new products and by leveraging our
recent Puniska and Saol baclofen franchise acquisitions towards our
goal of being top five in the U.S. institutional injectables market
and a global player over time,” said Chirag and Chintu Patel,
Co-Chief Executive Officers. “These four approvals, including two
products currently on the FDA drug shortage list, demonstrate our
commitment to the institutional market and to alleviating drug
shortages so that patients can have access to the medicines they
need,” said Harsher Singh, SVP for Amneal Biosciences.
Dexamethasone is a bioequivalent and therapeutically equivalent
generic to the reference standard dexamethasone sodium phosphate
injection, USP 10 mg/mL. This corticosteroid is currently on the
FDA drug shortage list. According to IQVIA®, U.S. annual sales for
dexamethasone injection for the 12 months ended December 2021 were
$66 million.
For full prescribing information, see package insert located
here.
Azactidine is the generic equivalent for Vidaza® Injection 100
mg. This antineoplastic drug is currently on the FDA drug shortage
list. According to IQVIA®, U.S. annual sales for azacitidine
injection for the 12 months ended December 2021 were $61
million.
For full prescribing information, see package insert located
here.
Carboprost is a generic version of the prostaglandin Hemabate®
Injection, 250 mcg/mL. According to IQVIA®, U.S. annual sales for
this product for the 12 months ended December 2021 were $57
million.
For full prescribing information, see package insert located
here.
Atropine is an anticholinergic agent. It is a bioequivalent and
therapeutically equivalent generic to the reference listed drug
atropine sulfate injection, USP, 0.5 mg/5 mL in a pre-filled
single-dose syringe. This product was granted CGT status. According
to IQVIA®, U.S. annual sales for this product for the 12 months
ended December 2021 were $1 million.
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 approximately 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.
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 or forecasts
for the future, including among other things: product research and
development; discussions of future operations; expected operating
results and financial performance; the Company’s strategy for
growth; regulatory approvals; market position and expenditures.
Words such as “plans,” “expects,” “will,” “anticipates,”
“estimates” 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 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; the impact of global economic conditions; direct
or indirect impacts of the ongoing COVID-19 pandemic; our ability
to obtain exclusive marketing rights for our products; the impact
of competition on our ability to set prices; 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 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 FDA product approval requirements; risks related to federal
regulation of arrangements between manufacturers of branded and
generic products; the impact of healthcare reform and changes in
coverage and reimbursement levels by governmental authorities and
other third-party payers; the continuing trend of consolidation of
certain customer groups; our reliance on certain licenses to
proprietary technologies from time to time; our dependence on
third-party suppliers and distributors for raw materials for our
products and certain finished goods; our dependence on third-party
agreements for a portion of our product offerings; our ability to
identify, make and integrate acquisitions or investments in
complementary businesses and products on advantageous terms; legal,
regulatory and legislative efforts by our brand competitors to
deter competition from our generic alternatives; the significant
amount of resources we expend on research and development; 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; and the
impact of severe weather. 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/20220217005171/en/
Anthony DiMeo Senior Director, Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
Historical Stock Chart
From Sep 2024 to Oct 2024
Amneal Pharmaceuticals (NYSE:AMRX)
Historical Stock Chart
From Oct 2023 to Oct 2024