Sidvim LifeSciences Private Limited

  Contents FDA approval in December 2022 General information PLI scheme for bulk drug witnesses, commissioning of 21 projects in 2022 Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD Intellectual Property FMC Corporation & Ors. vs Natco Pharma Limited on 5 December 2022 FDA approval in December 2022 We monitor FDA approvals of small molecules.  Adagrasib, approved in December 2022 by FDA. It is approved to treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy. It is developed by Mirati Therapeutics.  Several compounds are reported in patent family WO2019099524A1 One may note adagrasib is individualised in example 478 on page 1053. It seems many Indian companies have started development of this API.  1-Bromo-8-chloronaphthalene is basic raw material for synthesising adagrasib. Suddenly one can see import of this inte

  Contents FDA approval in December 2022 General information JRS Pharma plan to continue expanding our footprints in India, including producing quality excipients and introducing new products China’s daily output of ibuprofen, acetaminophen quadrupled in quick response to market needs Intellectual Property T 1742/19 (Pharmaceutical composition containing an anti-nucleating agent/ MERCK … of 10.11.2022 FDA approval in December 2022 Wishing a happy New Year to all our readers. Free image from internet  We monitor FDA approvals of small molecules.  This month FDA approved Lenacapavir to treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. It is significant addition in Gilead's HIV portfolio. Morningstar analyst Karen Andersen said in October that lenacapavir sales are expected around $1.5 billion at the peak. Initial patent disclosure WO 2018/035359 A1, this could

  Contents ANDA approvals in November 2022 General information API crisis, again: PLI in key pharma ingredients was supposed to reduce dependence on China. But the job’s only partly done U.S. Supreme Court has busy year ahead for intellectual property law Intellectual Property Sun Pharma Vs DWD Pharmaceuticals (Trademark Decision by Delhi HC) ANDA approvals in November 2022 We monitor ANDA approvals by Indian companies. In the month of November, there are about 83 ANDA approvals, including 12 tentative approvals.  Aurobindo was top of the list with 4 ANDA approvals in November, followed by Mankind, Alembic and Amneal, three each. Many companies are trying to seek Competitive Generic Therapy (CGT) designations and secure 180 days exclusivity. More details about CGT could be found here .  Glimpses of our observations are as below.  Drug Name Company Submission Status Sidvim comments MIDAZOLAMANDA  #216048 CIPLA LTD Tentative Approval This spray was first approved in May 2019