- 22 Mar 2023
- ICICIdirect Research
Zydus Lifesciences receives 180 days exclusivity for Tofacitinib tablets
ZYDUSLIFE - 511 Change: 2.35 (0.46 %)News: Zydus Lifesciences has received final approval for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg (USRLD: Xeljanz® Tablets) from USFDA.Zydus was one of the first ANDA applicants to submit a substantially complete 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. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US$900 mn in the US (IQVIA MAT December 2022)
Views: With 180 exclusivity ( albeit shared) this drug can enjoy better unit economics compared to other generics
Impact: Positive