Posts

Showing posts from April, 2022

API and IP Newsletter

Image
                                                                           Contents FDA approvals in first quarter 2022 General information Pharma industry to grow 8-10% in FY22; growth momentum likely to moderate in FY'23: ICRA Dr Reddy's Inks $61 Million Deal to Acquire Cidmus Brand in India from Novartis Intellectual Property Delhi HC’s interim order issued in favor of Novartis and directed Eris to deposit a sum of Rs.5 crores with Registrar General of the Court FDA approvals in first quarter 2022 In Sidvim we analyse FDA approvals. Time to time we have published individual approvals of small molecules, details of chemistry, sourcing information, our educated guesses about development by generic companies etc. Summary is in the below table. It is interesting to note 50% approvals are of large molecules. Industry is moving from Chemistry to Biology!  No. Drug Name Active Ingredient Approval Date Indication Type Innovator Peak Sales OB patent expiration 1 Quviviq dar

API and IP Newsletter

Image
Contents FDA approvals in March 2022 General information Ivermectin Does Not Reduce Risk of Covid Hospitalization, Large Study Finds Team creates new nanoplatform for delivering drugs into T cells Intellectual Property T 2521/18 (Aerosol formulations/JAGOTEC) FDA approvals in March 2022 We follow FDA approvals of small molecules. Ganaxoline: General information Ganaxoline is approved in March 2022 under the brand name Ztalmy. It is a medication used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).   Ztalmy (ganaxolone) oral suspension contains ganaxolone, a neuroactive steroid gammaaminobutyric acid A (GABAA) receptor positive modulator. Ganaxolone is a methyl-substituted (at the 3ß position) analog of the endogenous neurosteroid allopregnanolone, a derivative of progesterone.  Ganaxolone is a white to off-white crystalline powder that only exists in one crystal form and has low aqueous solubility.  Synthesis: WO1993018053A1