Actavis confirmed on 27 May 2014 that it had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for approval of generic saxagliptin hydrochloride tablets in 2.5 and 5 mg strengths. The product is a generic version of AstraZeneca and Bristol-Myers Squibb’s diabetes treatment Onglyza (saxagliptin).

Onglyza is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The drug was approved by FDA in July 2009 and by the European Medicines Agency (EMA) in October 2009.

AstraZeneca filed a lawsuit against Actavis on 23 May 2014 in the US District Court of Delaware to prevent Actavis from marketing its generic version prior to the expiration of US Patent No. 7,951,400 on 30 November 2028. Marketing exclusivity for Onglyza expires in the US on 31 July 2014.

For the 12 months ending 28 February 2014, Onglyza had total US sales of approximately US$532 million, according to IMS Health data. Actavis believes that it may be ‘first-to-file’ an ANDA for a generic version of Onglyza giving it 180 days of generics market exclusivity.

On 30 May 2014, Actavis announced that it has entered into an agreement with Cephalon to settle all outstanding patent litigation related to Actavis’ generic version of Nuvigil (armodafinil). Nuvigil is a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy.

Under the terms of the agreement, Actavis can market 100 and 200 mg armodafinil generics as of 1 June 2016, or earlier under certain circumstances. Given that the patent on pharmaceutical formulations of modafinil (US Patent No. 7,297,346) only expires in May 2024 this appears to be quite a result for the generics company. Although Actavis will only be able to market 50, 150 and 250 mg armodafinil generics beginning 180 days after the initial launch of generics of those dosage strengths.

For the 12 months ending 28 February 2014, Nuvigil had total US sales of approximately US$437 million, according to IMS Health data. Actavis also believes that it is the first-to-file for the generic versions of 100 and 200 mg Nuvigil and expects to be entitled to 180 days of generic market exclusivity.

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