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Mylan’s Generic Provigil Will Launch In August Under Teva Deal

This article was originally published in The Pink Sheet Daily

Executive Summary

The agreement allows Mylan on the market before Teva’s 180-day exclusivity rights for modafinil expire in late September. For Teva, the deal could be a way of appeasing the Federal Trade Commission’s anti-competition concerns over the wakefulness drug.

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Provigil Generic Exclusivity Decision “Eviscerates” Hatch-Waxman, FTC Says

In a strongly worded amicus brief filed in Mylan’s lawsuit against FDA, the Federal Trade Commission says it would have required different remedies in clearing Teva’s acquisition of Cephalon last year had it known the Israel-based firm would receive sole 180-day marketing exclusivity for modafinil.

Provigil Generic Exclusivity Dispute Keeps Lawyers Up At Night

Teva dropped its suit when FDA conceded the firm has 180-day marketing exclusivity for generic Provigil; Mylan then sued the agency claiming Teva lost its exclusivity rights with its acquisition of Cephalon.

Cephalon Loses Market Exclusivity On Provigil To Its Own Parent Company

Teva’s March 30 authorized generic launch appears to give it a jump over other modafinil ANDA holders, who had settled patent litigation with Cephalon and were expected to enter the market in April. Several companies are expected to share 180-day marketing exclusivity rights for modafinil, although the fate of Ranbaxy’s ANDA under a recently negotiated FDA consent decree remains unclear.

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