Sidvim LifeSciences Private Limited

  Contents DMFs filed in January 2023 General information New magic weight loss drug? Mounjaro controls diabetes and tackles obesity at the same time. Why it’s better than Semaglutide Moderna Partners With IBM Hoping AI Can Help Develop More mRNA Medicine Intellectual Property Claim construction in US District Court; Newron and Co Vs MSN and others. DMFs filed in January 2023 FDA publishes a quarterly list of DMFs filed by various API manufactures. We analyze those. Type II DMFs.  We study DMFs filed by Indian companies.  In the month of January about 50 DMFs were filed and as usual 50% of those were Indians. Some of our observations are as below. HOLDER SUBJECT SIDVIM Comments EVEREST ORGANICS LTD BEMPEDOIC ACID  Total 9 DMFs filed so far for bempedoic acid. In February 2020, the FDA approved Esperion's bempedoic acid under the brand name Nexletol. It is used to treat high BP. There could be many ANDA filers on NCE-1 date in February 2024.  AURO PEPTIDES LTD LIRAGLUTID

  Contents ANDA approvals in March 2023 General information Bird & Bird and Gilead invalidate two NuCana antiviral drug patents India needs to build antibiotic research ecosystem right away Intellectual Property Linagliptin: A Single Bench of the Delhi High Court has refused to grant interim injunction to Boehringer Ingelheim (BI) against generic manufacturers. ANDA approvals in March 2023 We follow ANDA approvals every month. In march there are over 120 ANDA approvals and among then about 20 are tentative approvals. Our brief comments are as below. Drug Name Company Sidvim comments MOXIFLOXACIN HYDROCHLORIDE ANDA  #204836 HETERO LABS  This approval is for 400 MG tablets. Other 5 Gxs are approved. This might not be very big market in US. We could not find out US market size information in public domain, but world-wide sale of moxi is about USD 118 mio. So, overall in US tablet market might not be very significant. VIGABATRIN ANDA  #214671 ZYDUS This approval is for 500

Contents FDA approvals General information Schizophrenia Clinical Trials Pipeline Analysis: 60+ Companies are Working to Improve the Treatment Space Duopharm to market Luye Pharma’s cholesterol management product in Malaysia Intellectual Property T 1349/21 – Decision by Appeal Board at EPO on patent related to low-alcohol beer FDA approvals We follow FDA approvals of small molecules and analyse brief IP situation of the approved molecule. We study API synthetic routes.  Last month Reata sought approval for Omaveloxolone. Brand name Skyclarys, this is a medication used for the treatment of Friedreich's ataxia. Friedreich ataxia (FA) is a rare inherited disease which causes progressive damage to nervous system and movement problems. FA is rare disease. However, still the most common form of hereditary ataxia in US, it affects about one in every 50,000 people. The approved, Omaveloxolone is a semisynthetic triterpenoid. Synthesis of Omaveloxolone is reported in WO2013163344A1 fr