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API and IP Newsletter

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  Contents DMF filed by Indian companies in April 2022 General information Five companies personalizing treatments with 3D printed drugs How can the pharma industry navigate issues in the global supply chain to minimise drug shortages? Intellectual Property T 2342/19 (Liquid formulation of AMG 416/AMGEN) of 21.6.2022 DMF filed by Indian companies in April 2022 We analyse DMFs filed by Indian companies. In April, about 50 DMFs were filed and out of which more than 60% were filed by Indian companies. Optimus was top among Indian DMF filers.  Some of our observations/comments are as below. HOLDER SUBJECT Sidvim comments OPTIMUS DRUGS PRIVATE LTD LINAGLIPTIN More than two dozen DMFs filed. There are Gx approvals in US. But Gx launch one has to wait for some time. In India innovator obtained ad interim injunction order against generic launches.  METROCHEM API PRIVATE LTD BILASTINE Two other DMFs filed. Bilastine is currently approved in more than 120 countries and achieved more

API and IP Newsletter

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  Contents Analysis of patent applications filed by Alembic General information Catalyst (CPRX) Settles Patent Dispute Over Sole Marketed Drug Firdapse (amifampridine) EU court adviser says Servier's pay-for-delay deals were anti-competitive Intellectual Property Novo sued Sun Pharma alleging patent infringement of Saxenda and Victoza (Liraglutide) Analysis of patent applications filed by Alembic Alembic files a sizable number of applications every year.  It is important to note, most of the applications are related to their ANDA filings and indicating towards their circumventing strategies of OB listed patents.  Glimpses of our observations are as below.  Publication Number Sidvim comments WO2022090953A1 Invention relates to solid dispersion of ponatinib. Ponatinib approved by FDA in December 2012, but later temporarily suspended sales on 31 October 2013 because of "the risk of life-threatening blood clots and severe narrowing of blood vessels". This suspensi