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Cephalon Loses Market Exclusivity On Provigil To Its Own Parent Company

This article was originally published in The Pink Sheet Daily

Executive Summary

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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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.

No Need To Fight: Teva Retains Provigil Generic Exclusivity Even Without “Adversarial” Relationship

U.S. Judge Ellen Segal Huvelle denies Mylan’s request to block the agency’s award of modafinil 180-day marketing rights to Teva. Mylan’s argument that the existence of an adversarial relationship between an ANDA first-filer and NDA holder is necessary for an award of generic marketing exclusivity is “fatally flawed,” the judge says, although she expresses sympathy for the plaintiff’s Hatch-Waxman policy arguments.

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During more than two-and-a-half hours of oral arguments, Judge Ellen Huvelle repeatedly asked Mylan’s counsel how the Hatch-Waxman Act gives her the power to order FDA to take modafinil 180-day exclusivity rights away from Teva. However, the judge also expressed “deep concern” that Teva would challenge FDA’s trigger decision and further delay other ANDA filers from coming to market.

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