TEPROTUMUMAB-TRBW | B761143 | HORIZON THERAPEUTICS IRELAND
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 12-Year BPCIA | Jan. 21, 2032 | Active | Computed |
| 7-Year Orphan | Jan. 21, 2027 | Active | Purple Book |
Purple Book Patents
No listed patents in Purple Book.
Estimated Patent LOE
Based on latest discovered patent 12358993(method of use) · relevance 95/100
Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.
5 AI-discovered patents, sorted by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alnylam Pharmaceuticals, Inc. FDA-2026-P-7229 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.