Sidvim LifeSciences Private Limited

  Contents Paragraph IV filings as of 07 August 2023 General information Delhi HC denies interim relief to Sun Pharma against Finecure in trademark dispute Will PLI schemes lead to a manufacturing renaissance? Intellectual Property Court found 'Mankind' and 'Novakind' marks confusing Paragraph IV filings as of 07 August 2023 FDA publishes list of Paragraph-IV filings. This list is here . We analyze new P-IV filings in this published list. Some of our observations are as below.  Drug Name            Dosage Form No of ANDAs  Sidvim Comments Dalbavancin HCl Powder For Injection 500 mg/vial ANDA submission 5/23/2023 RLD Dalvance FDA approval May 23, 2014 3 FDA approved dalbavancin in May 2014, for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by certain susceptible bacteria such as Staphylococcus aureus including methicillin-susceptible and methicillin-resistant strains of Streptococcus pyogenes.  It had GAIN Exclusivity, that ex

  Contents DMF filings by Indian companies General information Scientists have discovered a ground-breaking new way to make painkillers like Tylenol and ibuprofen out of a surprising source FDA Issues New Nitrosamine Impurities Guidance Intellectual Property Federal Circuit affirmed the district court’s decision that asserted claims of US 10,130,589 are invalid. DMF filings by Indian companies We analyze DMF filings by Indian companies. FDA recently published a quarterly DMF filing list. This week we analyzed DMFs filed in the month of May 2023. Some of our comments are as follows.  HOLDER SUBJECT Sidvim comments MAITHRI DRUGS PRIVATE LTD TRIFAROTENE Trifarotene is the first new retinoid approved by the FDA for the treatment of acne. Three other DMFs filed earlier. FDA approved Trifarotene in October 2019. US launch due to patent extension looks challenging before 2031. NCE-1 date will be in October 2023.  BIOPHORE INDIA PHARMACEUTICALS PVT LTD TRIENTINE TETRAHYDROCHLORIDE Trient