Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation.
The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of its product. The 180-day CGT exclusivity will not stop the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL, said the company.
Cipla’s Dihydroergotamine Mesylate Nasal Spray 4mg/mL is an AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s Migranal. The product marks Cipla’s first ANDA approval for a nasal spray, indicated for the acute treatment of migraine headaches with or without aura.
According to IQVIA (IMS Health), Migranal and its authorized generic equivalents had US sales of about $102 million for the 12-month period ending March 2020.
Cipla said that its product is available for shipping with immediate effect.