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API and IP Newsletter

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  Contents DMFs filed by Divis Laboratories General information Novartis' Sandoz sells Chinese finished drugs plant to CDMO Jiuzhou for $15.1M Olon Expands On Multiple Fronts Intellectual Property DMFs filed by Divis Laboratories We analyse DMFs filed by various Indian companies. This time we had a look at DMF list of Divis. Some of our observations are as below.  SUBMIT DATE SUBJECT Sidvim Comments 1/27/2022 TICAGRELOR There are more than 30 DMFs. Price will be very competitive. Moving to south every quarter. It will settle near $ 600-700/Kg.  4/30/2021 ORLISTAT Crowded market, 10 other DMFs, however, this seems to be innovator business for Divis. As per import-export database Divis is exporting to GSK at much higher price realisation than competitors.  3/9/2021 LACOSAMIDE Too many players 28 DMFs. Divis seems to be sending free customer samples to Yoshindo, Kyowa, Nissin, Takeda, Nippon. Divis must be eyeing Japanies market. 7/29/2017 VIGABATRIN USP MSN h...

API and IP Newsletter

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  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 mate...