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Pfizer’s Lyrica Gets Split Decision As FDA Raises The Formulation Bar For Generics

With Pfizer’s blockbuster pain drug facing numerous generic challengers, the pharma gets FDA to agree not to accept any pregabalin ANDA that would include a “not less than” minimum level for R-isomer impurities; Pfizer’s patent certification arguments fall flat, however.

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Pfizer’s Pain Eased By Another Lyrica Approval

Pfizer gains another indication for its blockbuster pain drug Lyrica, even as it fights off generic competition from a variety of sources.

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Pfizer Lyrica Citizen Petition Against Generics Argues Drug Impurities Should Have Ceiling, Not Floor

Lupin, Actavis and Wockhardt’s novel attempt to establish a “not less than” level for an impurity in their generic pregabalin as a tactic in patent litigation should be rejected, Pfizer argues.

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The End of an Era: Lipitor, Blockbuster Drugs and the Waxman/Hatch Model

Pfizer’s Lipitor goes generic—albeit with some decidedly unusual wrinkles. The biggest generic launch in history is a good moment to take stock of the transition away from the blockbuster model. The reaction to the milestone suggests that the industry’s critics may be having a harder time letting go of the old model than industry is.

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