ADALIMUMAB-ADBM | B761058 | BOEHRINGER INGELHEIM
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 12-Year BPCIA | Aug. 25, 2029 | Active | Computed |
| 1-Year Interchangeable | Apr. 15, 2023 | Expired | Purple Book |
Purple Book Patents
No listed patents in Purple Book.
Estimated Patent LOE
Based on latest discovered patent 12435303(manufacturing) · relevance 55/100
Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.
Approved Biosimilars
Top 50 of 67 AI-discovered patents by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Boehringer Ingelheim USA Corporation on behalf of Boehr... FDA-2020-P-2247 Boehringer Ingelheim USA Corporation, on behalf of Boehringer Ingelheim Pharmaceuticals, Inc., filed this citizen petition pursuant to 21 C.F.R. §§ 10.25 and 10.30 and section 351 of the Public Health Service Act, requesting that the FDA Commissioner interpret "strength" in section 351(k) of the PHS | 505(q) | 2020-12-03 | Denied | Boehringer Ingelheim USA Corporation on behalf of Boehringer Ingelheim Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.