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Showing posts from November, 2020

API and IP Newsletter

  Contents   Analysis of USDMFs filed in the month of August 2020.  General information.  Latest news on IP and coronavirus in Europe .  Bulk drugs park may attract INR 11,100 Cr.   Intellectual Property.  Basmati battle: Pakistan fights Indian bid for EU recognition of rice . Bolar exemption does not apply to offering to sell patented drugs   Analysis of USDMFs filed in the month of August 2020   Out of 46 DMFs filed in the month of August by various API companies, as usual about 50% were filed by Indian generic companies. More details and our views about each filing are provided in the table below. Sr HOLDER SUBJECT SIDVIM Comments 1 PHARMARESOURCES (KAIYUAN) CO LTD TICAGRELOR Several DMFs for Ticagrelor. Export price is currently ranging from $ 3,000-5,000/Kg. This should come down significantly in near future. 2 SOLARA A PHARMA SCIENCES LTD DIPYRIDAMOLE USP Many active DMFs. Companies are exporting to Europe and other regulated markets @ around $ 150-200/Kg) 3 BIOPHORE INDIA PHARMA

API and IP Newsletter

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  Contents   Key Financials of select Pharma Companies:  General information.  Natco Pharma eyes launch of 8-10 new drugs in India yearly .  Granules India gets USFDA nod for potassium chloride tablets used to treat hypokalemia .  Intellectual Property.  Patent infringement: UK High Case. Merck vs Wyeth (October 2020)    Key Financials of select Pharma Companies: For more details check attached file. https://drive.google.com/file/d/1WcbJREBrs0jYCM3WjAyFKB5nrKU7lAVO/view?usp=sharing General information Natco Pharma eyes launch of 8-10 new drugs in India yearly Natco Pharma aims to launch around 10 new products every year in the Indian market. ( Read more ) Granules India gets USFDA nod for potassium chloride tablets used to treat hypokalemia Drug firm Granules India on Thursday said it has received marketing approval from the US health regulator for Potassium Chloride extended release tablets, used for treatment of patients with hypokalemia . ( Read more )   Intellectual Property  

API and IP Newsletter

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  Contents   FDA approvals in October 2020.  General information.  Micro Labs to set up API facility near Bengaluru with INR 476 Cr investment   Healthcare Pharma going all out   Intellectual Property.  AstraZeneca in legal fight with 12 drug makers over diabetic drug Dapagliflozin. FDA approvals in October 2020   Drug Name Active Ingredient Approval Date FDA-approved use on approval date* Drug Class Veklury Remdesivir 10/22/2020 To treat COVID-19 Small molecule Press Release Inmazeb Atoltivimab, Maftivimab, and Odesivimab-ebgn 10/14/2020 To treat Ebola virus Monoclonal antibody Press Release Drug Trials Snapshot   Remdesivir: A lot has been discussed about Remdesivir in the last six months. We will keep our discussions confined to the chemistry of Remdesivir. The process is described in example 12 in WO2016069825A1 and example 4 WO 2017/184668, compound 9. Attached here and here . Example 4. (2S)-2-ethylbutyl 2-((((2R,3S,4R,5R)-5-(4-aminopyrrolo[l,2-firi,2,41triazin- 7-yl)-5-cvano-