A battle for a lucrative market
Being a major generics manufacturer in the US sounds like a licence to print money, even in an economic downturn. Mylan recently announced the launch of four new generics formulations: modafinil, lithium carbonate extended-release tablets, pioglitazone hydrochloride/metformin hydrochloride tablets and pioglitazone hydrochloride tablets. The first of these alone reached annual sales of Euros 1 billion when marketed as the originator brand, Provigil (modafinil), for the 12 months ending 30 June 2012.

But, you need good lawyers as well as pharmaceutical expertise. In a complicated story of acquisition and undisclosed agreements, Mylan started selling a generic version of the sleep disorder drug Provigil (modafinil) under the terms of a settlement with Teva Pharmaceutical Industries (Teva). Sales started on 10 August 2012, before Teva’s 180-day first-to-file generics marketing exclusivity expired. The agreement between the companies had to be reviewed by FDA, which described the struggle for approval as ‘a tumultuous first-filer fight with Teva’ [1]. Teva bought Provigil’s originator company, but although it was the first with its ANDA for the generic version, it was compelled to allow a competitor in under US antitrust rules.

Modafinil tablets 100 mg and 200 mg are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea and shift work disorder. No wonder they are popular.

Other FDA approvals
The other recent generics launches are less contentious. Lithium Carbonate extended-release tablets 450 mg are indicated for the treatment of episodes of bipolar (manic depressive) illness. Pioglitazone tablets 15 mg, 30 mg and 45 mg and pioglitazone hydrochloride/metformin hydrochloride tablets 15 mg/500 mg and 15 mg/850 mg are the generic versions of Takeda Pharmaceutical Company’s Actos tablets and Actoplus Met tablets, respectively. They are indicated, in combination with diet and exercise, to improve glycaemic control in adults with type 2 diabetes mellitus. FDA has awarded Mylan 180 days of generics marketing exclusivity on the latter two products.

Mylan CEO, Ms Heather Bresch, commented that ‘Mylan’s immediate launch of these products is representative of the company’s ongoing commitment to expand access to high quality, more affordable medicines.’ They also keep Mylan in a strong position as one of the world’s leading generics makers.

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