Executive Summary : | Cystic fibrosis transmembrane conductance regulator CFTR modulator therapies are designed to correct the malfunctioning protein made by the CFTR gene. Because different mutations cause different defects in the protein, the medications that have been developed so far are effective only in people with specific mutations. There are four CFTR modulators for people with certain CFTR mutations, Kalydeco ivacaftor, Orkambi lumacaftor/ivacaftor, Symdeko tezacaftor/ivacaftor, Trikafta elexacaftor/tezacaftor/ivacaftor The Indian Patent for the following drugs are expiring in near future. Sr No. Brand Name IP Details Product Patent 1 Kalydeco IN 282654 B Jun 24, 2025 Specific Product/ Ivacaftor 2 Orkambi IN262900 B Nov 08, 2026 Specific Product/ Lumacaftor 3 Symdeko Copackaged IN272379 B Apr 09, 2027 Generic and Specific Product/Tezacaftor 4 Trikafta Copackaged IN201737015848 A Oct 06, 2035 Status PGO filed by G. Srinivasa Rao on Mar 15, 2021 Generic Product/Elaxacaftor IN201917024177 A Aug 12, 2037 Status Reply to FER Specific Product/Elaxacaftor 5 Translarna IN230604 Apr 09, 2024 Product patent Objectives: To develop the process chemistry for Ivacaftor under patent to make it affordable once patent expires. To optimize the process of synthesis for Ivacaftor. To apply eco-friendly synthetic approaches in the process chemistry. • To characterize the synthesized product using spectral analysis. Outcome 1. A cost effective process for the synthesis of Ivacaftor will be proposed. 2. An affordable treatment for Cystic Fibrosis patients in India will be available. 3. A process patent will be filed. 4. The process developed will be transferred to industry for commercialization. |