API and IP Newsletter
Contents DMFs filed in May 2021. General information. Novartis may have the most new drug approvals, but Roche, Lilly and AbbVie's launches win on value . Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids . Intellectual Property. Entresto (Sacubitril/Valsartan) claims construction patent litigation. DMFs filed in May 2021 In SIDVIM, we analyze DMFs filings by Indian companies every quarter. This week we analyzed DMFs filed in the month of May 2021. Few representative cases are presented here. HOLDER SUBJECT SIDVIM comments MSN LABORATORIES PRIVATE LTD MOLNUPIRAVIR Third DMF. Many more DMFs would be expected soon. METROCHEM API PRIVATE LTD TOFACITINIB CITRATE Too many other DMFs. Nothing very specific here. Crystalline form patent till 2026. DR REDDYS LABORATORIES LTD ERIBULIN FRAGMENT-A First Indian DMF! Gx launch possible in US in 2023. CIPLA LTD BICTEGRAVIR SODIUM Fourth DMF and NCE-1 date in July 2022. One can expect many ANDA file