Sidvim LifeSciences Private Limited

Contents DMFs filed by Lupin Ltd General information Horizon Therapeutics Plc filed a lawsuit alleging that Apotex Inc.’s copy of Pennsaid 2% Ukraine: Cancellation of marketing authorizations for pharmaceuticals manufactured in Russia or Belarus or held by companies affiliated or otherwise related to those with manufacturing facilities in Russia or Belarus Intellectual Property Delaware Court ruled against Astellas Pharma and Gilead (innovator) in a patent case related to Regadenoson. Hospira succeeded. DMFs filed by Lupin Ltd We analyse DMFs filed by generic companies. This document covers only part of the analysis, of DMFs filed by Lupin, confining to only 4-5 DMFs filed in the recent past.  SUBMIT DATE SUBJECT SIDVIM Comments 3/31/2022 MIGALASTAT HYDROCHLORIDE  Third DMF filed, Migalastat. NCE-1 date is in October 2022. Many filers could be expected on NCE-1 date. 3/18/2022 VILANTEROL TRIFENATATE Approved in various combinations since 2013. Inhaler products. Lupin will f

  Contents FDA approval in May 2022- Tirzepatide General information Piramal Pharma Solutions New API Plant in Canada Goes Online; Initial Production Runs Successfully Completed Novartis looks to grow global CDMO unit after pandemic pacts put its strengths on display Intellectual Property Boehringer Ingelheim International Co. Vs Macleods Pharmaceuticals. Decision by HP High Court FDA approval in May 2022- Tirzepatide We follow FDA approvals. Tirzepatide was approved in May 2022.  Tirzepatide, brand name Mounjaro, is a  medication  used for the treatment  type 2 diabetes . Tirzepatide is given by injection under the skin. This is once weekly GIP receptor and GLP-1 receptor agonist. It is a 39-amino-acid modified peptide based on the GIP sequence. Tirzepatide contains 2 non-coded amino acids (aminoisobutyric acid, Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is