Purple Book product · Interchangeable
Osenvelt
denosumab-bmwo
At a glance
Feb 28, 2025
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Feb 28, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Strength
120MG/1.7ML (70MG/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of denosumab (Xgeva)
Patent list (57)
| Patent | Expires | In | Source |
|---|---|---|---|
| 8,058,418 | Nov 30, 2023 | 2 yr 7 mo ago | FDA |
| 7,364,736 | Feb 19, 2025 | 1 yr 4 mo ago | FDA |
| 7,427,659 | Mar 15, 2025 | 1 yr 3 mo ago | FDA |
| 8,247,210 | Dec 06, 2026 | in 6 mo | FDA |
| 8,460,896 | Dec 06, 2026 | in 6 mo | FDA |
| 8,680,248 | Dec 06, 2026 | in 6 mo | FDA |
| 8,217,153 | Jan 05, 2027 | in 7 mo | FDA |
| 7,928,205 | Feb 12, 2027 | in 8 mo | FDA |
| 7,888,101 | Apr 06, 2027 | in 10 mo | FDA |
| 7,662,930 | Apr 24, 2027 | in 11 mo | FDA |
| 9,359,435 | May 22, 2027 | in 1 yr | FDA |
| 8,053,236 | Jan 19, 2030 | in 3 yr 8 mo | FDA |
| 9,228,168 | Jan 19, 2030 | in 3 yr 8 mo | FDA |
| 9,320,816 | Nov 14, 2030 | in 4 yr 6 mo | FDA |
| 9,012,178 | Aug 05, 2031 | in 5 yr 3 mo | FDA |
| 9,133,493 | Apr 20, 2032 | in 6 yr | FDA |
| 9,388,447 | Apr 20, 2032 | in 6 yr | FDA |
| 11,292,829 | Jun 29, 2032 | in 6 yr 2 mo | FDA |
| 11,634,476 | Jun 29, 2032 | in 6 yr 2 mo | FDA |
| 11,685,772 | Jun 29, 2032 | in 6 yr 2 mo | FDA |
| 9,371,554 | Dec 14, 2032 | in 6 yr 8 mo | FDA |
| 11,293,930 | Mar 26, 2033 | in 6 yr 11 mo | FDA |
| 11,486,883 | Mar 26, 2033 | in 6 yr 11 mo | FDA |
| 9,328,134 | Feb 20, 2034 | in 7 yr 10 mo | FDA |
| 11,319,568 | Mar 10, 2034 | in 7 yr 11 mo | FDA |
| 11,459,595 | Mar 10, 2034 | in 7 yr 11 mo | FDA |
| 11,952,605 | Mar 10, 2034 | in 7 yr 11 mo | FDA |
| 12,084,686 | Mar 10, 2034 | in 7 yr 11 mo | FDA |
| 11,492,372 | Mar 11, 2034 | in 7 yr 11 mo | FDA |
| 10,421,987 | May 29, 2034 | in 8 yr 1 mo | FDA |
| 10,894,972 | May 29, 2034 | in 8 yr 1 mo | FDA |
| 11,434,514 | May 29, 2034 | in 8 yr 1 mo | FDA |
| 11,946,085 | May 29, 2034 | in 8 yr 1 mo | FDA |
| 9,481,901 | May 29, 2034 | in 8 yr 1 mo | FDA |
| 9,803,166 | Sep 29, 2034 | in 8 yr 5 mo | FDA |
| 11,299,760 | Oct 30, 2034 | in 8 yr 6 mo | FDA |
| 10,513,723 | Dec 09, 2034 | in 8 yr 8 mo | FDA |
| 11,254,963 | Dec 09, 2034 | in 8 yr 8 mo | FDA |
| 10,106,829 | Dec 11, 2034 | in 8 yr 8 mo | FDA |
| 10,227,627 | Dec 11, 2034 | in 8 yr 8 mo | FDA |
| 10,655,156 | Dec 11, 2034 | in 8 yr 8 mo | FDA |
| 10,907,186 | Dec 11, 2034 | in 8 yr 8 mo | FDA |
| 11,130,980 | Apr 05, 2035 | in 9 yr | FDA |
| 11,077,404 | May 13, 2035 | in 9 yr 1 mo | FDA |
| 11,384,378 | Jun 04, 2035 | in 9 yr 2 mo | FDA |
| 11,427,848 | Jun 04, 2035 | in 9 yr 2 mo | FDA |
| 10,583,397 | Jul 28, 2035 | in 9 yr 3 mo | FDA |
| 11,786,866 | Oct 21, 2035 | in 9 yr 6 mo | FDA |
| 11,192,919 | Nov 13, 2035 | in 9 yr 7 mo | FDA |
| 10,167,492 | Dec 01, 2035 | in 9 yr 8 mo | FDA |
| 10,822,630 | Dec 01, 2035 | in 9 yr 8 mo | FDA |
| 11,275,090 | Jul 02, 2037 | in 11 yr 3 mo | FDA |
| 11,098,079 | Jul 21, 2037 | in 11 yr 4 mo | FDA |
| 9,881,367 | Aug 09, 2037 | in 11 yr 4 mo | FDA |
| 12,025,618 | Aug 26, 2039 | in 13 yr 5 mo | FDA |
| 11,744,950 | Nov 21, 2039 | in 13 yr 8 mo | FDA |
| 12,059,555 | Sep 02, 2040 | in 14 yr 5 mo | FDA |
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Interchangeable
blaType · 351(k) Interchangeable
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Interchangeable Biologic
blaType · Interchangeable
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
