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First generic versions of Duetact and Maxalt approved Posted 01/02/2013

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

US-based Mylan announced on 2 January 2013 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for 5 mg and 10 mg rizatriptan benzoate tablets, as well as the 5 mg and 10 mg versions of the orally disintegrating tablets. Mylan’s products are generics of Merck’s Maxalt MLT and Maxalt tablets, which are indicated for the acute treatment of migraine with or without aura in adults.

Mylan’s ANDA for rizatriptan benzoate orally disintegrating tablets, as the first-to-file generic, will enjoy 180-days of exclusivity on the US market before other generics manufacturers will be allowed to market their products.

The 5 mg and 10 mg versions of rizatriptan benzoate orally disintegrating tablets had US sales of approximately US$262.5 million for the 12 months ending 30 September 2012, according to IMS Health. While the 5 mg and 10 mg versions of rizatriptan benzoate tablets had US sales of approximately US$344.7 million for the same period. Mylan intends to start shipping its generics immediately.

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 11 January 2013 that the US market introduction of its first-to-file pioglitazone hydrochloride/glimepiride tablets. Sandoz’s product is a generic of Takeda Pharmaceuticals’ Duetact, which is indicated as an adjunct to diet and exercise to improve the control of blood sugar in adults with type 2 diabetes mellitus who are already treated with certain diabetes medications or who have inadequate glycaemic control when using certain diabetes medications alone.

Diabetes affects nearly 26 million people in the US, which is about 8.3% of the population, representing a significant burden for the US healthcare system. Type 2 diabetes accounts for more than 90% of diabetes cases. The US Government, payers and patients will therefore welcome this new generic drug treatment as a way to reduce medication costs.

US sales for the brand-name version of pioglitazone hydrochloride/glimepiride tablets were approximately US$29 million for the 12 months ending November 2012, according to IMS Health.

Mylan is becoming a bit of an expert in first-to-file generics. The company currently has 183 ANDAs pending FDA approval representing US$79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing US$20.8 billion in annual brand-name sales, for the 12 months ending 30 June 2012, according to IMS Health.

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Source: Mylan, Sandoz

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