- 17 Apr 2025
- ICICIdirect Research
ZYDUS LIFESCIENCES AND LUPIN (DEFENDANTS) HAVE LOST THE PATENT LITIGATION AGAINST THE INNOVATOR ASTELLAS PHARMA
ZYDUSLIFE - 902 Change: 17.00 (1.92 %)News: Zydus LifeSciences and Lupin (defendants) have lost the patent litigation against the innovator Astellas Pharma (plaintiff) for the drug Myrbetriq (Mirebegron). Lupin had initially launched its version of Myrbetriq after receiving approval from the USFDA which was later challenged by Astellas in the court. Due to the latest court ruling the regulator's approval is overridden by the patent enforcement. Myrbetriq is a prescription drug indicated for patients suffering from overactive bladder (frequent or urgent urination and urinary incontinence).
View: According to our estimates Zydus and Lupin has registered ~US$ 170 million and ~ US$ 100 million from Mirabegron Extended-Release Tablets till date in the United States. The unfavorable ruling by the court is expected to block further sales of the product and the companies may also have to incur financial penalties pertaining to the cash generated from the product. We will revisit our estimates post Q4 earnings.
Impact: Negative