Sidvim LifeSciences Private Limited

  Contents FDA approvals in September 2022- Gadopiclenol General information Merck Wins Patent Ruling on Viatris’ Copies of Diabetes Drugs Central committee to look into regulation of pharma marketing practices Intellectual Property FDA approvals in September 2022- Gadopiclenol Elucirem™ (Gadopiclenol), a new macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced magnetic resonance imaging (MRI) approved by FDA. This contrast agent with high relaxivity indicated for use in adults and children aged 2 years and older.  The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). WO2020030618A1 discloses process of manufacturing of Gadopiclenol in example 2. WO2007042506A1 could be considered as composition of matter patent for Gadopiclenol.  Many companies importing raw materials required

  Contents FDA approvals in September 2022 General information Approval of 3 bulk drug parks a big boost to domestic API industry Rubius weighs up RI plant sale as part of pipeline restructure Intellectual Property FDA approvals in September 2022 We analyse FDA approvals of small molecules. Deucravacitinib (innovator BMS) was approved on 09 September 2022 to treat moderate-to-severe plaque psoriasis. There are not many FDA approved deuterated drugs. One can find review of FDA approved deuterated drugs here .  Synthesis reported for Deucravacitinib is as below Example 52 in WO2014074661A1 family discloses above synthesis.  WO2018183656A1 discloses Deucravacitinib crystal form A. For day-1 launch, assuming compound patent would be valid, generics have to circumvent BMS crystalline form patent family WO2018183656A1 Suzhou Pharma filed patent application WO2021143498A1 for crystalline form CSIII  From reaction scheme one would notice 2-methoxy-3-(1-methyl-1H-1,2,4-triazol-3-yl)an

  Contents ANDA approvals in August 2022 General information CBI chargesheet in Biocon case raises questions about how India manages drug trials Evolving real-time dissolution prediction and product release Intellectual Property The SPC application for EP(UK) 1809343 B1 (The decision of UK Court) ANDA approvals in August 2022 We analyse ANDA approvals every month. In August there are about 104 approvals and about 20% of those were tentative approvals.  ANDA  Company Sidvim comments IVERMECTIN ZYDUS The approval is for Cream; Topical 1%, two other ANDAs approved. Ivermectin 1% topical cream is used to treat lesions of rosacea. Rosacea is a skin disease that causes redness and pimples on your nose, cheeks, chin, and forehead. IQVIA June 2022 data, the company said Ivermectin cream had annual sales of $176 million in the US. This ANDA approval might not be big contributor to Zydus US business. CYCLOSPORINE STRIDES PHARMA Approval is for capsules, 25 mg, 50 mg and 100 mg. There