Amneal receives Xyrem generic approval after patent disputes
04 Jul 2023
Drug ApprovalBiosimilarPatent ExpirationPatent Infringement
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Source: Pharmaceutical Technology
Akosua Mireku
@AkosuaMireku1
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Source: Pharmaceutical Technology
Amneal is an American generics and speciality pharmaceutical company. Credit: JHVEPhoto via Shutterstock.
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.
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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.
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View allCompanies IntelligencePfizer IncJazz Pharmaceuticals PlcAmneal Pharmaceuticals IncAlmirall SAC R L IncView all
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.
The biotech launched 26 new generic products last year and received an ANDA for its generic version of Narcan (naloxone hydrochloride) in March 2023.
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How is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
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Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
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Download the full report to understand what to expect and how to align your strategies for success.
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Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
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Thailand (+66)
Togo (+228)
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Turkmenistan
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Tuvalu
Uganda
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