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API and IP Newsletter

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  Contents FDA approvals in January 2021.  General information.  FDA: Compounded Remdesivir Products Should Not Be Used .  Seqens majority owner looking to sell API maker amid record-high run in healthcare valuations: report   Intellectual Property.  Patent claims mNeonGreen technology. Granted claim in US is as follows   FDA approvals in January 2021   No. Drug Name Active Ingredient FDA-approved use on approval date* 1. Lupkynis Voclosporin To treat lupus nephritis 2 Cabenuva Cabotegravir and Rilpivirine To treat HIV Press Release 3 Verquvo Vericiguat To treat chronic heart failure In this write-up, we would evaluate synthetic APIs. Last week we looked at chemistry of Cabotegravir. This week, we will understand the synthesis and potential of Vericiguat for the generic pharmaceutical industry.    Vericiguat  Composition of matter patent of Riociguat WO2003095451A1 could be considered as basic patent for Vericiguat. A couple of processes of such compounds are disclosed in patent litera

API and IP Newsletter

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  Contents   FDA approvals in January 2021.  General information.  Reported ANDA litigation settlements in district court cases   Indian pharma industry expected to grow to $65 billion by 2024 .  Intellectual Property.  Valent Vs Zydus Claim construction .  FDA approvals in January 2021 No. Drug Name Active Ingredient FDA-approved use on approval date* 1 Lupkynis Voclosporin To treat Lupus Nephritis 2 Cabenuva Cabotegravir and Rilpivirine To treat HIV Press Release 3 Verquvo Vericiguat To treat chronic heart failure In this write-up we would evaluate synthetic APIs. Cabotegravir  PCT application WO 2006/116764 published on 2 November 2006, where the reaction depicted at page 80 from 16 to 17-1, could be a potential synthesis for Cabotegravir. A second reaction scheme is on page 113 of WO 2006/116764.  One more synthesis is reported as example A in WO2010/068253A1. This is a summary, but a lot of work has gone into the synthetic chemistry of Cabotegravir.  Major raw material (RM) would