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30 June 2014Americas

Forest sues to stop Aurobindo’s generic Namenda

New York-headquartered Forest Laboratories has filed suit against Indian company Aurobindo Pharma to protect Namenda, a treatment for moderate to severe Alzheimer’s disease.

In the complaint filed at the US District Court for the District of Delaware on Friday, June 27, Forest argued that Aurobindo has infringed patent 5,061,703, which covers “adamantane derivatives in the prevention and treatment of cerebral ischemia”.

It said that sometime on or before May 16, Aurobindo submitted an Abbreviated New Drug Application to the US Food and Drug Administration (FDA) for approval to make and sell 5 and 10 mg tablets containing active ingredient memantine hydrochloride before expiry of the ‘703 patent.

Forest, which is the patent’s exclusive licensee and distributes Namenda in the US, has asked for judgment that Aurobindo has infringed the patent, and that it receive monetary relief if Aurobindo makes, uses, offers for sale or sells in the US a generic product that infringes or contributes to the infringement of the ‘703 patent.

On June 18, the FDA granted Forest paediatric exclusivity for memantine hydrochloride, allowing it an additional six months of market exclusivity in the US, for both its Namenda and extended release Namenda XR products.

Forest said in a statement that it expects generic versions of Namenda to enter the market sometime in July 2015.

In the final quarter of 2013, Namenda made sales of $379.2 million. Namenda XR generated total sales of $37.8 million.


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20 August 2019   Amneal and three other generic makers have agreed to pay $1.54 million to settle a class-action lawsuit, which alleged the companies engaged in an unlawful scheme to maintain their monopoly over an Alzheimer’s drug.

More on this story

Americas
20 August 2019   Amneal and three other generic makers have agreed to pay $1.54 million to settle a class-action lawsuit, which alleged the companies engaged in an unlawful scheme to maintain their monopoly over an Alzheimer’s drug.