Sidvim LifeSciences Private Limited

  Contents Olutasidenib : FDA approval General information Pharma MSMEs oppose compulsory QR code on all APIs An Overview of Emerging Technologies within the Pharmaceutical Industry Intellectual Property T 0814/19 Olaparib solid dispersion/KUDOS 19.10.2022- Decision by the Appeal Board at EPO Olutasidenib : FDA approval Olutasidenib is approved in December 2022 by USFDA for the treatment of adults with relapsed or refractory acute myeloid leukaemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. It is also being evaluated in a Phase I trial for glioma.  A preparation of olutasidenib as a lyophilized solid form is described in WO2016/044789. This could be considered as composition of matter patent. Another patent family WO 2019222551 relates to crystalline form of Olutasidenib The step 5 in WO2019/222551A1 describes the process.  US equivalents of these families could be listed in Orange Book, and there could be an advantage in developing a novel polymorph of

  Contents DMF filed in the month of August 2022 General information FDA revises ANDA facility correspondence draft guidance Pharmaceutical Manufacturers Fight Fake Drugs with Intelligent Supply Chains Intellectual Property Delaware district court opined Slayback and Apotex's NDAs are non-infringing Eagle pharmaceutical’s OB listed patent for bendamustine product. DMF filed in the month of September 2022 We analyse DMF filings by Indian companies. This week we analysed DMFs filed in the month of September 2022.  Total 58 DMFs were filed in September 2022.  HOLDER SUBJECT SIDVIM COMMENTS USV PRIVATE LTD Dapagliflozin (Dapagliflozin 30% w/w solution in Isopropyl alcohol) Too many DMFs for dapagliflozin. There are many variants, amorphous, propanediol solvate etc. This 30% w/w solution in Isopropyl alcohol is smart filing by USV. There are formulations reported, where PEG is dissolved in a solvent mixture (isopropyl alcohol: methylene chloride mixture (1 : 1.5 ratio)), follo

  Contents DMF filed in the month of August 2022 General information HC imposes ₹10 lakhs on Sun Pharma for concealing facts The FDA Just Approved The Most Expensive Drug in The World Intellectual Property Teva vs Novartis: England and Wales High Court (Patents Court) DMF filed in the month of August 2022 We analyse DMF filings by Indian companies. We had not it for a while and in this week we analysed DMFs filed in the month of August.  Total 51 DMFs were filed in August 2022.  HOLDER SUBJECT Sidvim comments MSN LABORATORIES PRIVATE LTD PRUCALOPRIDE SUCCINATE Four other DMFs filed. Product approval in US was in December 2018. NCE-1 date will be on 14 December 2022. It will be interesting to see how many companies file ANDA on NCE-1 date. Prucalopride was approved for medical use in the European Union in 2009, in Canada in 2011, in Israel in 2014, so, innovator samples were available for FDF development much before US approval. No OB listed patents and hence one can expect