Intellectual Property: Long Acting Injectables
AKAGERA Medicines patent protection is robust with broad geographical scope. Our global patent filings (over 75, including 7 granted US patents) provide patent protection through 2041-2045 for the molecular therapeutics and vaccine pipeline assets and additional research discoveries. Most products are protected by multiple patent filings with different expiration dates, if granted.
Molecular Therapeutics Pipeline:
Existing Akagera patent filings protect each molecular therapeutics oxazolidinone pipeline asset through at least June 2041 (compound) and December 2042 (LNP formulation). Specifically, the AKG-100 and AKG-120 molecular therapeutics API compounds are each covered by Akagera patent filings expiring in June 2041 (granted in the US, pending global coverage in Europe, Japan, Africa region and a dozen other countries) with additional pending patent filings on the AKG-100 and AKG-120 LNP formulations expiring in December 2042, if granted (in the US, Europe, Japan, Africa region and a dozen other countries).
In addition to patent protection the AKG-100 and AKG-120 molecular therapeutic products will be granted NCE small molecule product regulatory exclusivity upon first approval in the US (5-years from NDA approval) and Europe (10-years upon EMA approval), applicable to any subsequent attempts to gain approval for generic versions of either product.
mRNA-Based Vaccine Pipeline:
Our ligand-targeted vaccine pipeline assets contain multiple components protected by global patent filings through at least May 2043. Specifically, the Akagera vaccine pipeline products include a patented cationic lipid through November 2041 (patented in the United States with pending patent filings in the African Region, Europe, Japan and a dozen other countries), and proprietary ligand-targeting components patented through May 2043 (patented in the United States, with pending patent filings in the African Region, Europe, Japan and over a dozen other countries). In addition, the mRNA payload of the AKG-200 tuberculosis vaccine is covered by additional global patent filings through December 2043.
In addition to patent protection the vaccine candidates will be granted Reference Product Exclusivity biologic product regulatory exclusivity upon first approval in the US (12-years from NDA approval) and Europe (10-years upon EMA approval), and applicable to any subsequent attempts to gain approval for biosimilar versions of any product.