A layered approach to commercial exclusivity
Exclusivity is built in layers — a granted composition-of-matter patent at the foundation, method-of-use protection through granted and pending filings, an active continuation strategy, and regulatory exclusivity that stacks independently of any patent outcome. The structure is designed so that protection does not depend on a single filing.
Composition of Matter
Covers the purified Vepoloxamer molecule itself and the supercritical fluid extraction process. Granted in the United States, Europe, Japan, Korea, Australia and Taiwan.
Method of Use
Broad claims to administering Vepoloxamer to protect non-targeted cells from radiation damage and other forms of cellular injury. Granted in Japan. Under prosecution in the United States and Europe, with a parallel continuation strategy in place.
Continuation Strategy
An active continuation program layering filings around specific formulations, dosing regimens, sub-populations and new indications — including new method-of-use filings generated through academic sponsored research, each carrying an independent term from filing.
Regulatory Exclusivity
Regulatory exclusivity runs independently of any patent outcome: New Chemical Entity exclusivity (5 years at first approval); New Clinical Investigation exclusivity (+3 years per new indication); Pediatric Exclusivity (+6 months); Orphan Drug exclusivity (7 years) where applicable.
These regulatory exclusivities are prospective and do not currently apply to Vepoloxamer. If the FDA approves Vepoloxamer, one or more exclusivities may be available if the applicable requirements are met. Vepoloxamer is not FDA-approved for any indication.
Vepoloxamer is an investigational drug and has not been approved by the U.S. Food and Drug Administration for any use.
Forward-Looking Statements: This page contains forward-looking statements, including statements regarding anticipated patent terms, prosecution outcomes, regulatory exclusivities, and clinical development plans. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including the risks that patents may not issue or be enforceable, that clinical trials may not succeed, and that regulatory approvals may not be obtained. LifeRaft Biosciences undertakes no obligation to update these statements, except as required by applicable law.