The drug major on Thursday (21 May) said it received final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate nasal spray from the US drug regulator with competitive generic therapy (CGT) designation.
Cipla is the first approved applicant for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla's product. However, the CGT designation will not block the commercialization of the existing approvals of the said product.
The Dihydroergotamine Mesylate nasal spray is AB-rated generic therapeutic equivalent version of Bausch Health US' Migranal. This is Cipla's first ANDA approval for a nasal spray. It is 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 approximately $102 million for the 12-month period ending March 2020.
Cipla is a global pharmaceutical company focused on complex generics, and deepening portfolio in India, South Africa, North America, and key regulated and emerging markets.
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On a consolidated basis, the drug maker's net profit declined 33% to Rs 245.95 crore on a 0.7% rise in net sales to Rs 4301.60 crore in Q4 March 2020 over Q4 March 2019.
Shares of Cipla was currently down 0.45% at Rs 617.55. It has traded in the range of Rs 613.15 and Rs 626.60 so far during the day.
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