Cipla gets FDA nod for generic Migranal

Patients with acute migraine headaches with or without aura have a new generic treatment option. The Food and Drug Administration has given Cipla the green light for dihydroergotamine mesylate nasal spray in a dosage strength of 4mg/mL.

The product is the generic of Bausch Health's Migranal. This is Cipla's first ANDA approval for a nasal spray. As the first approved applicant, Cipla is eligible for 180 days of exclusivity which will begin to run from the commercial marketing of Cipla's product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of dihydroergotamine mesylate nasal spray, 4 mg/mL.

Migranal and its authorized generic equivalents had a market value of roughly $102 million for the 12 months ended March 2020, according to IQVIA.

Cipla's product is available for shipping immediately.