INTERFERON GAMMA-1B | B103836 | HORIZON THERAPEUTICS IRELAND DAC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 25, 1999 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Feb. 10, 2007 | Passed | no live block |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 12281176(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
37 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 12 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421299 | Other | Sep. 18, 2045Active | Discovered |
| 12281176 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12023378 | Formulation/compound | Jun. 27, 2044Active | Discovered |
| 11976127 | Other | May. 2, 2044Active | Discovered |
| 11891435 | Formulation/compound | Feb. 1, 2044Active | Discovered |
| 11827717 | Formulation/compound | Nov. 23, 2043Active | Discovered |
| 11530275 | Formulation/compound | Dec. 15, 2042Active | Discovered |
| 11466087 | Formulation/compound | Oct. 6, 2042Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11370838 | Other | Jun. 23, 2042Active | Discovered |
| 11221324 | Other | Jan. 6, 2042Active | Discovered |
| 11198732 | Formulation/compound | Dec. 9, 2041Active | Discovered |
| 11059908 | Formulation/compound | Jul. 8, 2041Active | Discovered |
| 10829551 | Formulation/compound | Nov. 5, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
Top 50 of 1,123 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.