US-based Amneal Pharmaceuticals has announced the US launch of its authorised generic for Ireland’s Jazz Pharmaceuticals’ Xyrem (sodium oxybate) after previous legal clashes.
In a company announcement on 3 July, Amneal also announced the recent US Food and Drug Administration (FDA) approval of five complex generics in Q2 2023.
This includes its generic versions of Pfizer’s Depo-Provera (medroxyprogesterone acetate), Pfizer’s Precedex (dexmedetomidine hydrochloride) and Novartis’ Arranon (nelarabine), Almirall’s Aczone (dapsone), and Organon’s Nasonex (mometasone furoate).
Xyrem is a treatment that acts as a central nervous system depressant in cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy.
Amneal’s sodium oxybate generic joins a wave of others following a patent expiry of Jazz’s narcolepsy drug. In 2019, Jazz Pharmaceuticals attempted to dispute the patent via a US Court of Appeals lawsuit opposing the FDA’s approval of a rival narcolepsy drug Avadel’s Lumryz. However, the regulatory agency won the lawsuit in February 2023, forcing the company to delist a patent related to Xyrem, thus opening the door for the successful approval of more Xyrem generics.
Jazz Pharmaceuticals received US approval for Xyrem in October 2002, making it the first and only medicine approved in the indication, with the label being expanded to treat excessive daytime sleepiness in 2005. Despite its approval, sodium oxybate is associated with serious safety concerns such as seizures, comas and death. As a result, the FDA restricts the prescription of the therapy under the Risk Evaluation and Mitigation Strategy (REMS) programme. This means that the drug can only be prescribed by a certified prescriber and can only be given to an enrolled patient by a certified pharmacy. It is not currently available in retail pharmacies.
In the 30 June press release, Amneal’s co-CEOs Chirag and Chintu Patel said: “By adding these new medicines to our portfolio, Amneal is on track to launch more than 30 new generics products this year.”
The biotech launched 26 new generic products last year and received an ANDA for its generic version of Narcan (naloxone hydrochloride) in March 2023.
In addition, the FDA recently issued a complete response letter (CRL) to Amneal’s Parkinson’s disease treatment IPX203. The CRL requested further pharmacokinetic data from the company.
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