<h1>Pharma launches two FDA-approved JAK inhibitors domestically, raising ANDA, bioequivalence, DMF and Section 505(j) risks for market entry</h1> A pharmaceutical company announced domestic launches of two JAK inhibitors already approved by the US FDA, positioning itself as first-to-market locally for these molecules. The move raises regulatory and compliance implications tied to bioequivalence, ANDA pathways, and active DMF listings cited by the company. The firm highlights extensive patent filings and global regulatory dossiers, which may affect freedom-to-operate and potential IP challenges. The launch emphasizes pricing and access policy considerations, potential liability for safety/labeling, and competitive market-entry risks for other manufacturers and payors in the autoimmune therapeutics segment.