Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a 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. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.
Cipla’s Dihydroergotamine Mesylate Nasal Spray 4mg/mL is AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s 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 U.S. sales of approximately $102M for the 12-month period ending March 2020.
Cipla’s product is available for shipping immediately.
Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
Cipla, constantly work towards ensuring access to high quality and affordable medicines to support patients in need. Which is why, they have been trusted by health care professionals and patients across geographies for the last 8 decades.
Over last 2 years, Cipla has been focusing towards establishing its Engine 2.0 of growth based on the foundation of Innovation and Specialty medicine. The Company has committed significant capital towards acquiring and in-licensing assets which address unmet clinical needs of patients.
The focus has been to establish a franchise of specialty medicines in the areas of Respiratory, CNS and Critical Care with a focus to build Institutional Specialty business. The operations of a Specialty focused company differ significantly from the operations of a generic company and hence to establish a robust business model, Cipla Technologies LLC (CipTec) has been established with its headquarters in San Diego, California. This also gives the Company ability to participate and operate in the biotech and life sciences innovation hub in the US.