TEPROTUMUMAB-TRBW | B761143 | HORIZON THERAPEUTICS IRELAND
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jan. 21, 2020 — 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 | Jan. 21, 2027 | 2mo 17d remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2027-01-21) advances biosimilar entry from the full-label date to now (no remaining licensure floor). Product-level orphan data — the specific indication(s) to drop are not yet attributed.
Carveable orphan wall · Jan. 21, 2027
Orphan-drug exclusivity runs past the licensure floor, 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 now, 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.
0 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 0 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358993 | Method-of-use (carveable) | Jul. 10, 2045Active | Discovered |
| 12286481 | Method-of-use (carveable) | Apr. 24, 2045Active | Discovered |
| 12209130 | Method-of-use (carveable) | Jan. 23, 2045Active | Discovered |
| 11208489 | Method-of-use (carveable) | Dec. 23, 2041Active | Discovered |
| 11208490 | Method-of-use (carveable) | Dec. 23, 2041Active | Discovered |
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.
5 AI-discovered patents, sorted by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alnylam Pharmaceuticals, Inc. FDA-2026-P-7229 · 10 docket documents Alnylam Pharmaceuticals, Inc. filed this citizen petition requesting that the FDA take regulatory action concerning RNAi therapeutics and their approval pathway. The petition seeks clarification or modification of FDA guidance related to the development and review of RNA interference-based drugs, sp | Other | 2026-06-30 | Open | Alnylam Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.