Sidvim LifeSciences Private Limited

  Contents Analysis of imports by Glenmark General information Strengthening regulatory framework, India to join the global quality scheme Manufacturing Technology Trends Intellectual Property The court’s decision favours Merck in Sugammadex and the complexity associated with Patent term extension. Analysis of imports by Glenmark We analysed patent applications filed by Glenmark last week. That was primarily to understand what they are developing in their development centre and to analyse the company’s long-term plan. This week we analysed their imports and tried to substantiate our inference from the IP analysis last week. Glimpses of our observations are as below.  Import by Glenmark Qty in KG Sidvim Comments BROMIDE  TIOTROPIUM  0.01 Glenmark is importing tiotropium bromide in small lots from Chemo Iberica in Italy. This could be for their potential 505 (b) (2) application to deliver the drug through a nebuliser, which is different from the marketed meter dose formulation. G

  Contents Analysis of patent families filed by Glenmark in the recent past. General information FDA updates the list of off-patent drugs without an approved generic Sourav Ganguly and Anil Kumble partner with Mankind Pharma Intellectual Property Astellas lost the case for extended-release drug formulations of mirabegron. Analysis of patent families filed by Glenmark in the recent past. We analyse patent applications filed by leading pharmaceutical companies in India. This week we chose Glenmark. Glenmark filed about 40 PCT applications in the last 4 years.  Some of our observations are as below. Publication Number Title - DWPI Publication Date SIDVIM comments WO 2023047323A1 Preparation of amorphous omadacycline tosylate for treating adult patients with community-acquired bacterial pneumonia infection involves contacting omadacycline with a mixture of alcohol and ether, treating the mixture with p-toluene sulphonic acid monohydrate, and adding antisolvent to the mixture 2023-03-

  Contents FDA approvals in May 2023 General information Alzheimer’s Drug Market To Hit $13B As FDA Approvals And Insurance Coverage Escalate Merck lawsuit opens new effort to cripple drug price negotiations Intellectual Property Amgen USA, Inc.’s Motion To Intervene For The Limited Purpose Of Asserting The Public Interest In Access To Judicial Records FDA approvals in May 2023 We follow FDA approvals in small molecule segment. We don’t give much emphasis on mechanism of action in this newsletter.  But we cover, chemistry, brief intellectual property around the molecule. By studying IP we come to know about active players, what kind of API should be developed for Day-1 launch etc.  We further analyse import export database and try to understand who potential early developers will be and who would be in position to file DMF soon.   FDA approved Sotagliflozin on 26 May 2023.  Sotagliflozin ( INPEFA ) is an orally administered dual SGLT1/2 inhibitor used alongside insulin  to im