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Allergan allows Amneal to market Alzheimer’s generic in 2025 Posted 23/09/2016

Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement will enable Amneal to market generic versions of the drug from 2025 onwards. 

The action began in 2015, when Allergan brought a patent infringement case against Amneal following its application to market generic versions of Namzaric (memantine and donepezil hydrochlorides). According to Allergan, Amneal was the first company to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for Namzaric.

The drug combines the active ingredients from its Namenda XR formulation – which is used to treat moderate to severe dementia – and Aricept – which was originally developed by Eisai and Pfizer and is mainly used for mild to moderate dementia. The once-daily combination drug was developed by Allergan alongside Adamas Pharmaceuticals (Adamas). Allergan owns the exclusive US commercialization rights, while Adamas retains commercialization rights outside of the country.

The deal reached between Allergan/Adamas and Amneal will allow Amneal to market generic versions of Namzaric from 1 January 2025, provided they gain approval from the US Food and Drug Administration. The companies did not disclose any further terms of the settlement.

The company struck a similar deal with Amneal over Namenda XR late in 2015, under which Amneal can begin marketing a generic version of the drug in January 2020 [1]. More recently, Teva won a patent battle with Allergan’s subsidiary Forest Laboratories over the drug, which Teva claimed infringed on a patent for analgesics [2].

Allergan has brought similar action against privately-held company Amerigen Pharmaceuticals, who has also filed an ANDA for Namzaric. Its application remains pending in the US District Court for Delaware.

In a statement, Allergan said it was proud of its commitment to providing therapies for people suffering with Alzheimer’s disease. The company has recently expanded Namzaric to enable patients with a moderate to severe form of the disease to start on the combination therapy. Almost three quarters of patients are in this stage but only a third currently receive combination therapy, which could be more beneficial than taking a single drug, such as Aricept. The company are also developing new compounds to treat the disease, including first-in-class small molecules targeting muscarinic receptors in the brain.

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1. GaBI Online - Generics and Biosimilars Initiative. Allergan makes deal with Amneal over its Namenda XR generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Generics/News/Allergan-makes-deal-with-Amneal-over-its-Namenda-XR-generic
2. GaBI Online - Generics and Biosimilars Initiative. Patent wins and losses for Teva. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Generics/News/Patent-wins-and-losses-for-Teva

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Source: Allergan

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