Drugs

Pfizer Wants Exclusivity for Duavee Component

Pfizer is petitioning FDA to grant five-year exclusivity for bazedoxifene, a new active moiety that is in its fixed-dose combination drug Duavee (conjugated estrogens/bazedoxifine). The 9/30 petition says that Duavee has already been granted a three-year exclusivity period that expired 10/3, making time of the essence for considering the petition.

Duavee was approved 10/3/13 for use in women with a uterus to treat moderate to severe vasomotor symptoms associated with menopause and to prevent postmenopausal osteoporosis. Before approving Duavee, the petition says, FDA had never approved an NDA for any drug substance containing bazedoxifine or any of its esters or salts as an active moiety, but had previously approved drugs containing conjugated estrogens.

At the time of Duavee’s approval, FDA did not make a determination as to the exclusivity period to which it was entitled, pending a decision on three citizen petitions seeking five-year exclusivity for certain fixed-dose combination products containing both a new active moiety and a previously approved active moiety. In 2014, the agency issued a consolidated response to the petitions agreeing with the petitioners’ interpretation of the relevant statutory language governing five-year exclusivity, but declining to apply that interpretation to fixed-dose combination products approved before FDA finalized a new guidance on the topic.

Under terms of the consolidated response, the petition says, FDA approved three-year exclusivity for Duavee. The agency later denied a Pfizer petition challenging that decision.

When Ferring Pharmaceuticals, one of the companies that had submitted a petition seeking five-year exclusivity, filed suit in DC federal court, challenging FDA’s historical interpretation of the exclusivity provisions to deny five-year exclusivity to fixed-dose combination containing both a new active moiety and a previously approved drug substance as arbitrary and capricious, the court agreed in a 9/9 opinion.

Pfizer says that its Duavee is similarly situated to Ferring’s Prepopik and thus asks FDA to reconsider its decision not to grant five-year exclusivity to bazedoxifene in light of the court decision.

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