DENOSUMAB | B125320 | AMGEN
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 12-Year BPCIA | Jun. 1, 2022 | Expired | Computed |
| 7-Year Orphan | Dec. 5, 2021 | Expired | Purple Book |
Purple Book Patents (57)
| Patent | Expiration | Status |
|---|---|---|
| 10106829 | Dec. 11, 2034 | Active |
| 10167492 | Dec. 1, 2035 | Active |
| 10227627 | Dec. 11, 2034 | Active |
| 10421987 | May. 29, 2034 | Active |
| 10513723 | Dec. 9, 2034 | Active |
| 10583397 | Jul. 28, 2035 | Active |
| 10655156 | Dec. 11, 2034 | Active |
| 10822630 | Dec. 1, 2035 | Active |
| 10894972 | May. 29, 2034 | Active |
| 10907186 | Dec. 11, 2034 | Active |
| 11077404 | May. 13, 2035 | Active |
| 11098079 | Jul. 21, 2037 | Active |
| 11130980 | Apr. 5, 2035 | Active |
| 11192919 | Nov. 13, 2035 | Active |
| 11254963 | Dec. 9, 2034 | Active |
| 11275090 | Jul. 2, 2037 | Active |
| 11292829 | Jun. 29, 2032 | Active |
| 11293930 | Mar. 26, 2033 | Active |
| 11299760 | Oct. 30, 2034 | Active |
| 11319568 | Mar. 10, 2034 | Active |
| 11384378 | Jun. 4, 2035 | Active |
| 11427848 | Jun. 4, 2035 | Active |
| 11434514 | May. 29, 2034 | Active |
| 11459595 | Mar. 10, 2034 | Active |
| 11486883 | Mar. 26, 2033 | Active |
| 11492372 | Mar. 11, 2034 | Active |
| 11634476 | Jun. 29, 2032 | Active |
| 11685772 | Jun. 29, 2032 | Active |
| 11744950 | Nov. 21, 2039 | Active |
| 11786866 | Oct. 21, 2035 | Active |
| 11946085 | May. 29, 2034 | Active |
| 11952605 | Mar. 10, 2034 | Active |
| 12025618 | Aug. 26, 2039 | Active |
| 12059555 | Sep. 2, 2040 | Active |
| 12084686 | Mar. 10, 2034 | Active |
| 7364736 | Feb. 19, 2025 | Expired |
| 7427659 | Mar. 15, 2025 | Expired |
| 7662930 | Apr. 24, 2027 | Active |
| 7888101 | Apr. 6, 2027 | Active |
| 7928205 | Feb. 12, 2027 | Active |
| 8053236 | Jan. 19, 2030 | Active |
| 8058418 | Nov. 30, 2023 | Expired |
| 8217153 | Jan. 5, 2027 | Active |
| 8247210 | Dec. 6, 2026 | Active |
| 8460896 | Dec. 6, 2026 | Active |
| 8680248 | Dec. 6, 2026 | Active |
| 9012178 | Aug. 5, 2031 | Active |
| 9133493 | Apr. 20, 2032 | Active |
| 9228168 | Jan. 19, 2030 | Active |
| 9320816 | Nov. 14, 2030 | Active |
| 9328134 | Feb. 20, 2034 | Active |
| 9359435 | May. 22, 2027 | Active |
| 9371554 | Dec. 14, 2032 | Active |
| 9388447 | Apr. 20, 2032 | Active |
| 9481901 | May. 29, 2034 | Active |
| 9803166 | Sep. 29, 2034 | Active |
| 9881367 | Aug. 9, 2037 | Active |
Top 50 of 102 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-11-14 | Active | — | |
| D.N.J. | 2025-11-06 | Active | — | |
| D.N.J. | 2025-11-06 | Active | — | |
| D.N.J. | 2025-07-16 | Terminated 2026-01-22 | — | |
| D. Mass. | 2025-06-30 | Terminated 2025-07-15 | — | |
| D.N.J. | 2025-06-25 | Active | — | |
| D.N.J. | 2025-06-25 | Terminated 2025-11-24 | — | |
| D.N.J. | 2025-02-07 | Terminated 2025-03-11 | — | |
| NCED | 2024-11-13 | Terminated 2025-02-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen Health Research Group FDA-2019-P-1818 Public Citizen Health Research Group filed this petition on April 16, 2019, under Section 352 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA add a boxed warning to Prolia (denosumab) labeling describing the risk of vertebral fractures upon treatment discontinuation and implement | Other | 2019-04-17 | Partially Denied | Public Citizen Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.