Purple Book product · Interchangeable
Ponlimsi
denosumab-adet
At a glance
Mar 27, 2026
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Mar 27, 2026
2 mo ago
Today
Pharmaceutical detail
Strength
60MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2325
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
N
Reference product family
View full familyBiosimilar of denosumab (Prolia)
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
12 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
