Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US.
The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug.
An ANDA is shorter than an NDA or new drug application, as it is filed for the generic version of a branded molecule.
Since these molecules are copies of approved drugs, they do not need to go through the kind of safety and efficacy trials that new drugs have to, thus making the applications shorter.
The branded version of the drug is called Xeljanz and is sold in the US by Pfizer.
It controls join inflammation by inhibiting the activity of Janus kinases or JAKs, and is used to treat adults with moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis, and similar conditions.
Zydus Cadila said the drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
“The group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04,” it added.
The company was in the news last week for becoming the first in the world to get approval for a DNA-based COVID vaccine.