Sidvim LifeSciences Private Limited

Contents Recent ANDA approvals General information Jazz pays $145m to resolve Xyrem antitrust disputes Bristol Myers Freed From Blood Cancer Drug Antitrust Litigation Intellectual Property Roxadustat decision: T 0072/23 (Photostable roxadustat formulation/FIBROGEN) Recent ANDA approvals We track ANDA approvals monthly. This report discusses the ANDA approvals obtained by generic companies in March 2025. There are approximately 86 ANDA approvals for March 2025, of which 23 are tentative approvals. Interestingly, out of the total 86 approvals, 47 were received by Indian companies.  Below is the list of top ANDA approvals. Some of our observations for the approved products are as follows. General information Jazz pays $145m to resolve Xyrem antitrust disputes Jazz Pharma has agreed to pay $145 million to settle lawsuits claiming it illegally acted to prevent generic versions of its narcolepsy therapy Xyrem from entering the US market. The lawsuits – which date back to 2020...

Contents Recent 505 (b) (2) filings. General information Pharmaceutical Drug Regulation and Mortality: Evidence from Electronic Cigarettes First-in-Class Drugs Offered Greater Regulatory Flexibility in the US vs Europe Intellectual Property Roche vs Natco -Risdiplam -Delhi High Court Recent 505 (b) (2) filings.  We follow 505 (b) (2) filings every month. This write-up consists of 505 (b) (2) NDA approvals for March 2025.  General information Pharmaceutical Drug Regulation and Mortality: Evidence from Electronic Cigarettes Exempting e cigarettes from FDA regulation reduced mortality attributable to smoking by approximately 10 percent For comparison, a prior study found that a $1 increase in cigarette taxes experienced between the ages of 14 and 17 reduced mortality by 4 percent. Furthermore, our findings reveal that the regulation exemption reduced the causes of death most associated with smoking by the largest amount.  News here First-in-Class Drugs Offered Gr...