Sidvim LifeSciences Private Limited

  Contents Recent FDA approvals: Bexagliflozin General information ‘ Pay ₹2 Cr to Pfizer or go to jail’: Delhi HC to Triveni Interchem director Mesirow Institutional Investment Buys Shares of 377,099 Amphastar Pharmaceuticals, Inc. Intellectual Property Glenmark Pharmaceuticals ... vs Sanjeevni Medicos And Ors on 20 January 2023 Recent FDA approvals: Bexagliflozin We follow small molecule approvals by USFDA and study synthesis reference, analyse very brief IP situation, try to estimate who would be the potential DMF filers in near future. In January FDA approved Bexagliflozin.  It will be sold under the brand name Brenzavvy. It is an antidiabetic medication used to improve glycaemic control in patients with type 2 diabetes. This is developed by a small biotech company, Theracos. Specific compound patent (and process) family: WO2010/022313 Crystalline form patent family: WO2011/153712A1 The chemical name of bexagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(2-cyclopropoxyet

  Contents DMFs filed in December 2022 General information China adds 111 new drugs to NRDL, focus on innovation Single-Arm Versus Randomized Trials for FDA Approvals of Cancer Drugs Intellectual Property Valsartan and Sacubitril: Natco Pharma Limited vs Assistant Controller Of Patents DMFs filed in December 2022 We monitor DMFs filed by Indian companies. FDA publishes list of DMF filers every quarter, the new list of DMF filers in last quarter of year 2022 was published recently.  This week we analysed DMFs filed in the month of December 2022. About 95 DMFs filed in the month of December.  Some of our observations are as below. HOLDER SUBJECT Sidvim Comments SOLAR ACTIVE PHARMA SCIENCES LTD NAPROXEN SODIUM USP Naproxen is high volume old product. There are not many DMFs filed though. Divis is very strong in supply of naproxen. Solar Active must compete with Divis for the market share. MSN LIFE SCIENCES PRIVATE LTD NIRMATRELVIR  Third DMF.  It is part of a nirmatrelvir/rito