Sidvim LifeSciences Private Limited

  Contents Analysis of DMF filings in July 2021.  General information.  Pyxis IPO leads the way as four life science firms kick off 4Q, raising nearly $500M.  API price hike hits pharma units.  Intellectual Property.  Vortioxetine decision by Delaware court in USA.    Analysis of DMF filings in July 2021 We analyse DMF filings by Indian companies. This month we had looked at DMFs filed in the month of July 2021 and as expected more than 50% of total DMFs filed in July were by Indian companies. Due to space constraint, we cannot cover all DMFs filed in the month, nevertheless, some of the observations are as below.  Holder Subject Sidvim Comments MSN LIFE SCIENCES PRIVATE LTD IRBESARTAN USP Out of 28 DMFs filed, 8 are inactive! Must be due to nitrosamine issues. MSN filed DMF in 2021, this is about 9 years after Divis filed DMF in 2012. METROCHEM API PRIVATE LTD LOXOPROFEN SODIUM HYDRATE Old drug. No OB listed patents. Overall requirement would be less than couple of MT/a BIOPHORE INDIA

  Contents Analysis of FDA approvals.  General information.  Delhi HC rules in favour of Dr. Reddy’s in OMEZ trademark case.  The Latest Regulatory Guidance for Data Integrity and Regulatory Compliance.  Intellectual Property.  Sun Pharma Vs Cipla: Covid cannot be used as an excuse for Passing off (Madras HC)    Analysis of FDA approvals The below table summarizes FDA approvals in the month of September 2021. We will analyse approvals of small molecules.  Drug Name Active Ingredient FDA-approved use on approval date Livmarli maralixibat To treat cholestatic pruritus associated with Alagille syndrome Qulipta atogepant To prevent episodic migraines Tivdak tisotumab vedotin-tftv To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Exkivity mobocertinib To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations Let us look at maralixibat in this newsletter.   SIDVIM comme