GOLIMUMAB | B125433 | JANSSEN BIOTECH
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Jul. 18, 2013), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Jul. 18, 2025 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 29, 2027 | 1y 2mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age", protected through 2027-09-29) advances biosimilar entry from the full-label date to the estimated 12-year floor.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age(label indication #4) | Sep. 29, 2027 | Jul. 18, 2025(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Sep. 29, 2027
Orphan-drug exclusivity runs past the licensure floor above, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest at the floor date, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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 12303483(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
34 formulation/compound (cap skinny entry) · 10 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12258393 | Method-of-use (carveable) | Mar. 20, 2045Active | Discovered |
| 12227593 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 12018075 | Other | Jun. 20, 2044Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11946939 | Other | Mar. 28, 2044Active | Discovered |
| 11780911 | Method-of-use (carveable) | Oct. 5, 2043Active | Discovered |
| 11779643 | Other | Oct. 5, 2043Active | Discovered |
| 11674951 | Other | Jun. 8, 2043Active | Discovered |
| 11359029 | Formulation/compound | Jun. 9, 2042Active | Discovered |
| 11220531 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 11192951 | Formulation/compound | Dec. 2, 2041Active | Discovered |
| 11149094 | Formulation/compound | Oct. 14, 2041Active | Discovered |
| 11123492 | Other | Sep. 16, 2041Active | Discovered |
| 10918737 | Method-of-use (carveable) | Feb. 11, 2041Active | Discovered |
Showing 15 of 55 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.
44 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.