Sidvim LifeSciences Private Limited

Contents Givinostat General information 20 Most Expensive Drugs in the World The ANDA boost Intellectual Property Vortioxetine hydrobromide tablets Givinostat This week let us discuss Givinostat.  It is not approved yet by USFDA. It is not a drug yet! Givinostat (originally ITF2357) was discovered at Italfarmaco of Milan, Italy. It was patented in 1997 and first described in the scientific literature in 2005. Italfarmaco announced recently that the USFDA has extended the review process of the New Drug Application (NDA). The company is seeking approval for the treatment of Duchenne Muscular Dystrophy (DMD).  The new date for a decision under the Prescription Drug User Fee Act (PDUFA) is now set for 21 March 2024. There is high likelihood that Givinostat will be approved by FDA in March 2024.  It has been granted orphan drug designation in the European Union for the treatment of systemic juvenile idiopathic arthritis,...

  Contents FDA approval: Fruquintinib General information UK Supreme Court has final say on Dabus as named inventor Anti-trust lawsuit against Natco Pharma over generic cancer drug dismissed in US Intellectual Property Institute of Directors vs Worlddevcorp Technology And Business Solutions Pvt Ltd FDA approval: Fruquintinib We follow FDA approvals of small molecules. Objective is to understand chemistry and IP around the molecule. Raw materials required to synthesise API and by analysing import-export database, try to make an educated guess about which generic companies who would be working on dossier development/ANDA. FDA approved Fruquintinib on 8 November 2023. Fruquintinib, sold under the brand name Fruzaqla, is an anti-cancer medication used for the treatment of colorectal cancer. Fruquintinib is a kinase inhibitor. Fruquintinib is a white to off-white powder. Fruquintinib capsules for oral administration contain 1 mg or 5 mg of fruquintinib...

  Contents DMFs filed in the month of September 2023 General information Novartis Nabs FDA Nod for Rare Disease Drug Rival to AstraZeneca Meds Piramal Pharma has launched a high-throughput screening facility Intellectual Property Sorafenib tosylate (Nexavar) case in Germany DMFs filed in the month of September 2023 In September 2023,  total 114, Type-II DMFs were filed, out of which about 63 DMFs were filed by Indian companies, MSN was at the top of list, filed 6 DMFs, Aurobindo filed 4 DMFs. Some of our product specific observations are as below. HOLDER SUBJECT COMMENTS GLAND PHARMA LTD FOSAPREPITANT DIMEGLUMINE There are 16 other DMFs and over one dozen ANDA filers for 150 MG injection. It is used for the prevention of nausea and vomiting. This is low volume API high value API.  MSN LABORATORIES PRIVATE LTD "LEVOTHYROXINE SODIUM USP"   This is very old compound, there are 10 DMFs filed, this is priced at USD 5000-10000/KG, and relatively small volu...