Purple Book product · Biosimilar 351(k)
Idacio
adalimumab-aacf
At a glance
Dec 13, 2022
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Dec 13, 2022
3 yr 6 mo ago
Today
Pharmaceutical detail
Strength
40MG/0.8ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2146
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of adalimumab (Humira)
- 2002HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2002HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2008HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2013HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2014HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2015HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2016HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2016HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2022IdacioBiosimilar 351(k)
adalimumab-aacf · Fresenius Kabi USA, LLC
Patent list (66)
| Patent | Expires | In | Source |
|---|---|---|---|
| 8,911,737 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 8,974,790 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 8,992,926 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 9,546,212 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 6,805,686 | May 06, 2023 | 3 yr 2 mo ago | FDA |
| 8,906,373 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,067,992 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,085,620 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,090,689 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 8,961,973 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,961,974 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,986,693 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,061,005 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,187,559 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,512,216 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,808,700 | May 16, 2026 | 19 d ago | FDA |
| 11,083,792 | Apr 04, 2027 | in 10 mo | FDA |
| 8,231,876 | Apr 04, 2027 | in 10 mo | FDA |
| 8,883,156 | Apr 04, 2027 | in 10 mo | FDA |
| 8,895,009 | Apr 04, 2027 | in 10 mo | FDA |
| 8,906,372 | Apr 04, 2027 | in 10 mo | FDA |
| 8,916,153 | Apr 04, 2027 | in 10 mo | FDA |
| 9,096,666 | Apr 04, 2027 | in 10 mo | FDA |
| 9,102,723 | Apr 04, 2027 | in 10 mo | FDA |
| 9,273,132 | Apr 04, 2027 | in 10 mo | FDA |
| 9,328,165 | Apr 04, 2027 | in 10 mo | FDA |
| 9,913,902 | Apr 04, 2027 | in 10 mo | FDA |
| 8,926,975 | Jun 08, 2027 | in 1 yr | FDA |
| 8,715,664 | Jul 24, 2027 | in 1 yr 2 mo | FDA |
| 8,663,945 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,906,646 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,911,964 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,090,867 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,234,032 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,284,371 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,889,136 | Oct 09, 2027 | in 1 yr 4 mo | FDA |
| 9,284,370 | Jun 10, 2028 | in 2 yr 1 mo | FDA |
| 9,669,093 | Jun 10, 2028 | in 2 yr 1 mo | FDA |
| 11,167,030 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 11,191,834 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 9,085,619 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 8,420,081 | Jan 13, 2030 | in 3 yr 8 mo | FDA |
| 8,999,337 | Feb 06, 2031 | in 4 yr 9 mo | FDA |
| 9,624,295 | Mar 31, 2031 | in 4 yr 11 mo | FDA |
| 8,708,968 | Jan 24, 2032 | in 5 yr 9 mo | FDA |
| 9,339,610 | Jan 24, 2032 | in 5 yr 9 mo | FDA |
| 9,062,106 | Apr 26, 2032 | in 6 yr | FDA |
| 9,090,688 | Apr 26, 2032 | in 6 yr | FDA |
| 9,505,834 | Apr 26, 2032 | in 6 yr | FDA |
| 9,522,953 | Apr 26, 2032 | in 6 yr | FDA |
| 9,683,033 | Apr 26, 2032 | in 6 yr | FDA |
| 9,957,318 | Apr 26, 2032 | in 6 yr | FDA |
| 9,085,618 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,181,337 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,181,572 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,290,568 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,334,319 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,346,879 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,359,434 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,499,616 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,708,400 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,315,574 | Apr 21, 2033 | in 7 yr | FDA |
| 9,150,645 | May 13, 2033 | in 7 yr 1 mo | FDA |
| 9,266,949 | May 13, 2033 | in 7 yr 1 mo | FDA |
| 9,499,614 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 9,550,826 | Nov 14, 2034 | in 8 yr 7 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) Biosimilar
blaType · 351(k) Biosimilar
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Biosimilar
blaType · Biosimilar
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
