India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 February 2018 that it had launched a generic version of Allergan’s Alzheimer’s disease treatment Namenda XR (memantine XR).
The launch follows the approval of Lupin’s generic memantine XR at dosages of 7, 14, 21 and 28 mg by the US Food and Drug Administration (FDA) back in September 2016. FDA also approved versions from rival generics makers Mylan Pharmaceuticals and Sun Pharma.
Namenda XR is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. In 2017, memantine hydrochloride XR capsules 7, 14, 21 and 28 mg had annual sales of approximately US$936 million in the US, according to Lupin.
Forest Laboratories (Forest) – an American pharmaceutical company acquired by Actavis [1] then subsequently by Allergan – had tried to stop generics of its extended release version. Forest filed a lawsuit in the US against several generics makers back in 2014 [2]. This was followed by more controversy when Actavis planned to discontinue the immediate-release version of its Alzheimer’s drug Namenda IR and switch patients to the extended-release version Namenda XR but was forced to continue making the drug [3].
This latest launch is just one of many from generics maker Lupin, which is the fourth largest pharmaceutical player in the US by prescriptions. It is India’s second largest and the world’s seventh largest generics maker. It is also expanding its presence around the world. In August 2017, it bought 21 generic brands from Japanese company Shionogi & Co [4]. Lupin is also foraying into the world of biosimilars and has made deals with Australian biotech firm Neuclone to access cell line technology to be used to develop biosimilar drugs targeting cancer [5] and with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan [6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Actavis to acquire specialty drugmaker Forest Labs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Pharma-News/Actavis-to-acquire-specialty-drugmaker-Forest-Labs
2. GaBI Online - Generics and Biosimilars Initiative. Forest Labs files lawsuit to stop generic memantine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Generics/News/Forest-Labs-files-lawsuit-to-stop-generic-memantine
3. GaBI Online - Generics and Biosimilars Initiative. Actavis agrees to continue making Alzheimer’s drug for now [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Generics/News/Actavis-agrees-to-continue-making-Alzheimer-s-drug-for-now
4. GaBI Online - Generics and Biosimilars Initiative. Indian generics manufacturer Lupin buys 21 brands from Japan’s Shionogi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Generics/General/Indian-generics-manufacturer-Lupin-buys-21-brands-from-Japan-s-Shionogi
5. GaBI Online - Generics and Biosimilars Initiative. Lupin and Neuclone biosimilars agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Neuclone-biosimilars-agreement
6. GaBI Online - Generics and Biosimilars Initiative. Lupin and Yoshindo start biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 16]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture
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