- 13 Sep 2022
- ICICIdirect Research
Zydus Lifesciences gets USFDA aproval for Cariprazine
ZYDUSLIFE - 1128 Change: -4.15 (-0.37 %)News: Zydus Lifesciences has received USFDA final approval to market Cariprazine capsules, in strengths of 1.5 mg, 3 mg, 4.5 mg and 6 mg (USRLD: VRAYLAR). Zydus was one of the first ANDA applicants and is eligible for 180 days of shared generic drug exclusivity for Cariprazine capsules. The drug is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic episodes associated with bipolar disorder. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ and had annual sales of US$2.39 billion in the US (IQVIA MAT July 2022).
View: Allergan had filed litigation in the US district court for the district of Delaware in December, 2019 against Sun Pharma, Aurobindo Pharma and Zydus Lifesciences to enforce patent rights relating to cariprazine. Net revenues for Vraylar increased from US$951 million in CY20 to US$1728 million in CY21, an increase of 82% in 2021 due to higher market share and market growth. The drug offers a substantial opportunity to Zydus and possibly to other litigators as well.
Impact: Positive.