Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the launch of its authorized generic for Xyrem¹ (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)