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Impax confirms patent challenge to generic FENTORA by Cephalon and CIMA Labs.

M2 EQUITYBITES-November 22, 2011-Impax confirms patent challenge to generic FENTORA by Cephalon and CIMA Labs(C)2011 M2 COMMUNICATIONS

Impax Laboratories Inc (Nasdaq:IPXL) on Monday confirmed that it had initiated a challenge of the patents listed in the Orange Book in connection with Fentora (fentanyl buccal tablets, 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg).

Impax had filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Fentora with the US Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification.

On 18 November 2011, Cephalon Inc and CIMA Labs Inc filed suit for patent infringement against Impax Laboratories in the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, intends to commercialise the product.

Fentora is used to treat 'breakthrough' cancer pain that is not controlled by other medicines.

Impax is a technology based specialty pharmaceutical company.

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Publication:M2 EquityBites (EQB)
Date:Nov 22, 2011
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