- Launches authorized generic for Xyrem® (sodium oxybate) in the
U.S., representing another new complex generic product launch
- Receives U.S. FDA approval for five new complex generics in
the second quarter
- Remains on track to deliver more than 30 new generic launches
in 2023
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the launch of its authorized generic for
Xyrem®1 (Sodium Oxybate) oral solution CIII in the United
States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous
system depressant indicated for the treatment of cataplexy or
excessive daytime sleepiness (EDS) in patients seven years of age
and older with narcolepsy. In addition, the Company announced it
has received Abbreviated New Drug Application (ANDA) approvals from
the U.S. Food and Drug Administration (“FDA”) for five complex
generics products. Three recently approved products are
injectables, including dexmedetomidine injection which is currently
on the U.S. FDA shortage product list.
“The launch of an authorized generic version of Xyrem represents
another new complex product launch as we further expand our U.S.
generics portfolio,” said Chirag and Chintu Patel, Co-Chief
Executive Officers. “We are seeing continued momentum across our
growing #4 U.S. Generics business and a steady cadence of
innovation with new complex generics. By adding these new medicines
to our portfolio, Amneal is on track to launch more than 30 new
generics products this year.”
The five recently approved products include:
Product
Dosage Category
U.S. IQVIA sales (TTM April 2023)
1
Medroxyprogesterone acetate injectable
suspension, USP 150mg/mL (1mL)
Injectable
$114 million
2
Dexmedetomidine hydrochloride in 0.9%
sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100
mL)
Injectable
$102 million
3
Nelarabine injection, 250mg/50mL
(5mg/mL)
Injectable
$29 million
4
Dapsone 7.5% gel
Topical
$47 million
5
Mometasone furoate nasal spray, 50 mcg
(OTC)
Nasal Spray
N/A – OTC
Medroxyprogesterone acetate Injectable suspension, USP 150mg/mL
(1mL) is a generic version of Depo-Provera®. For full prescribing
information, see package insert located here.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection,
4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of
Precedex® Injection. For full prescribing information, see package
insert located here.
Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version
of Arranon® Injection. For full prescribing information, see
package insert located here.
Dapsone 7.5% gel is a generic version of Aczone®. For full
prescribing information, see package insert located here.
Mometasone furoate nasal spray, 50 mcg is a generic
over-the-counter version of Nasonex®. For full prescribing
information, see package insert located here.
IMPORTANT SAFETY INFORMATION FOR SODIUM OXYBATE
Sodium Oxybate Oral Solution carries a boxed warning for central
nervous system (CNS) depression and abuse and misuse. Taking Sodium
Oxybate with other Central Nervous System (CNS) depressants has
been associated with trouble breathing (respiratory depression),
low blood pressure (hypotension), changes in alertness
(drowsiness), fainting (syncope), and death.
Sodium Oxybate is a form of gamma hydroxybutyrate (GHB). Abuse
or misuse of illegal GHB alone or with other CNS depressants (drugs
that cause changes in alertness or consciousness) may result in
seizures, trouble breathing (respiratory depression), changes in
alertness (drowsiness), coma, and death. Patients on Sodium Oxybate
should be monitored for confusion, anxiety, and suicidality.
Because of these risks, Sodium Oxybate is available only through
the XYWAV and XYREM REMS. Patients must be enrolled in the XYWAV
and XYREM REMS to receive Sodium Oxybate Oral Solution.
For full prescribing information, see package insert located
here.
References:
- Xyrem® is a registered trademark of Jazz
Pharmaceuticals, Inc.
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 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 roups; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230703416732/en/
Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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