FDA June 2026 OPOE List: 699 Immediate ANDA Opportunities, Lupin’s Kalydeco Patent Win, & Global GMP Warnings
Summary of this blog post: 5-minute read API & IP Intelligence Roundup (31 August 2026) This edition highlights major pipeline opportunities from the USFDA’s June 2026 Off-Patent, Off-Exclusivity (OPOE) list , key global regulatory compliance actions, and a major Hatch-Waxman patent ruling where Lupin defeated Vertex Pharmaceuticals over Kalydeco (ivacaftor) . 1. Niche Generic Pipeline: USFDA Releases Updated OPOE Drug List (June 2026) The USFDA published its biannual update to identify approved reference products that have no patent or regulatory exclusivity barriers and lack approved generic (ANDA) equivalents . Part I (Immediate Filing Opportunities): Lists 699 prescription products for which the Agency can immediately accept an ANDA without prior consultation . This includes 42 solid oral tablet products , such as: Oncology & Speciality: Chlorambucil (2 mg), Busulfan (2 mg), Mitotane (500 mg), and Hydroxyurea (100 mg) . Infectious Disease: Pivmecillinam HCl (Eq...
