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API and IP Newsletter

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  Contents   FDA approvals in November 2020.  General information.  Will take some time to shift API volumes from China to India: Granules India .  Indoco Remedies wins tenders worth INR 140 Cr for supply of kidney stones treatment drug in Germany .  Intellectual Property.  Melatonin: Neurim vs Mylan UK High Court case.   FDA approvals in November 2020 No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date 1 Danyelza Naxitamab-gqgk 11/25/2020 To treat high-risk refractory or relapsed neuroblastoma 2 Imcivree Setmelanotide 11/25/2020 To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age Drug Trials Snapshot 3 Oxlumo Lumasiran 11/23/2020 To treat hyperoxaluria type 1 Press Release Drug Trials Snapshot 4 Zokinvy Lonafarnib 11/20/2020 To treat rare conditions related to premature aging Press Release Drug Trials Snapshot...

API and IP Newsletter

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  Contents Analysis of Sun Pharma’s patent filing strategy Part I  General information.  Adamas Pharma (ADMS) Announces Agreement to Settle Patent Litigation with Osmotica .  HHS Shuts Down FDA's Unapproved Drugs Initiative . Intellectual Property. Analysis of Sun Pharma’s patent filing strategy Part I Many generic companies do work on their IP strategies soon after the innovator launches the product. Earlier, we analysed the import-export database of Sun Pharmaceuticals and we discovered Sun is no different than the other top generic companies in terms of molecule selection for development. However, there were a few very interesting products in their development portfolio. This week, we started analysing the patent portfolio of Sun Pharma where priority filing dates would be from late 2012 to late 2014. This means research activities must have started at least one year prior to the priority date. So, patent families listed below could have been reflecting research p...