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API and IP Newsletter

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  Contents Recent FDA approvals: Aprocitentan General information Evergreening Strategy: Extending Patent Protection, Innovation or Obstruction? How to reskill and upskill yourself in the pharma industry Intellectual Property Natco Pharma Vs Novartis AG Recent FDA approvals: Aprocitentan We follow FDA approvals, mainly small molecules. We briefly discuss IP and chemistry. We further analyse the import-export database to understand who would be the potential generic developers and try and estimate their stage of development.  Aprocitentan was approved for medical use in the USA in March 2024. It is the first endothelin receptor antagonist to be approved by the US FDA to treat systemic hypertension. Chemical name: (5-(4-bromo-phenyl)- 6-[2-(5-bromo-pyrimidin-2-yloxy)-ethoxy]-pyrimidin-4-yl}-sulfamide. Aprocitentan, sold under the brand name Tryvio, is a medication used to treat hypertension. It is developed by Idorsia.  Aprocitent...

API and IP Newsletter

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  Contents ANDA approvals in April 2024 General information US FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable* biosimilar to Humira Sandoz reaches agreement with Amgen to resolve all patent litigation related to its denosumab biosimilars Intellectual Property Natco Pharma Vs Novartis AG ANDA approvals in April 2024 We follow ANDA approvals. In April 2024, there were about 91 ANDA approvals and eight tentative approvals. The below companies received 2 or more than 2 ANDA approvals in April 2024.  Company ANDA approvals AUROBINDO PHARMA LTD 4 ALEMBIC 3 DR REDDYS 3 FRESENIUS KABI USA 3 LUPIN LTD 3 NOVARTIS 3 ABBVIE INC 2 ANNORA PHARMA 2 AUROBINDO PHARMA 2 DAY ONE BIOPHARMACEUTICALS INC 2 GLAND PHARMA LTD 2 INFORLIFE 2 LUMICELL 2 MACLEODS PHARMS LTD 2 SKG PHARMA 2 SOMERSET 2 TORRENT 2 Some of our other observations are as follows.  Active Ingredients Company Comments CLINDAM...