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Zydus Pharmaceuticals was one of the first ANDA applicants to submit a substantially complete abbreviated new drug application (ANDA) with a paragraph IV certification for Tofacitinib Tablets, 5 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Tofacitinib Tablets, 5 mg.
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of adult patients with active psoriatic arthritis. It is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).
According to IQVIA MAT December 2022, Tofacitinib Tablets, 5 mg and 10 mg had annual sales of $900 million in the United States.
The group now has 352 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.
The scrip rose 0.39% to currently trade at Rs 479.80 on the BSE.
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