Sidvim LifeSciences Private Limited

  Contents FDA approval in August 2023: Zuranolone General information Mankind Pharma sets a new benchmark launches 120 premium DMF quality drugs for Indian patients Ten drugs targeted for Medicare price negotiations as Biden pitches cost reductions Intellectual Property Delaware district court found Brivaracetam compound patent valid and infringed FDA approval in August 2023: Zuranolone We follow FDA approvals.  Zuranolone was approved by FDA for medical use in the treatment of postpartum depression in August 2023. Zuranolone, sold under the brand name Zurzuvae. ZURZUVAE™ (zuranolone), the first and only oral treatment approved for women with postpartum depression.  We cover chemistry and brief IP/regulatory aspect in this write-up. We generally do not comment about clinical studies and mechanism of action of the drug. We analyse import-export database and post our educated guesses about generic product development.  WO 2014169833  Example 20 of WO 2014169833 teaches the synthes

Contents DMF filings in the month of June 2023 General information Mallinckrodt to Go Bankrupt for Second Time in Three Years A novel approach to boost drug development in paediatric oncology Intellectual Property Delaware district court found Lonsurf patent valid and infringed DMF filings in the month of June 2023 We follow DMF filings by Indian companies. One of the trends which is very visible in recent past is percentage of DMF filings by Indian companies is going down. Out of total 56 DMFs filed in the month of June 2023, almost 50% are from Chinese companies and about 25% are from Indian companies.    HOLDER SUBJECT Sidvim Comments HONOUR LAB LTD TAFAMIDIS MEGLUMINE Tafamidis is becoming very competitive market especially for API supplier. There are more than 10 DMFs filed so far. As per FDA website 4 ANDAs were submitted on NCE-1 date for Tafamidis 61 MG capsule. NCE-1 date was in May 2023. Tafamidis is medication used to delay disease progression in adults with certain fo