FDA Orange Book · active-ingredient family
Ibrutinib
Ibrutinib is approved as 3 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IMBRUVICA · NDA 217003
3
Brand (NDA)
1
Generics (ANDA)
84
Listed patents
28
Exclusivity periods
Brand (NDA) products · capsule, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMBRUVICARLD | PHARMACYCLICS LLC | NDA 217003 | — | Aug 24, 2022 | |
| IMBRUVICARLD×4 | PHARMACYCLICS LLC | NDA 210563 | — | Feb 16, 2018 | |
| IMBRUVICARLD×2 | PHARMACYCLICS LLC | NDA 205552 | — | Dec 20, 2017 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBRUTINIB×2 | ZYDUS LIFESCIENCES | ANDA 211344 | — | Mar 31, 2021 |
Marketing exclusivity (28)
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPNew product exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
- NPPNew patient population exclusivity (3 years)
Aug 24, 2025
10 mo ago
- ODE-405Orphan-drug exclusivity (7 years)
Aug 24, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 24, 2026
4 mo ago
Listed patents (84)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8952015 | Dec 28, 2026 | in 6 mo | U-1650 |
| 8497277 | Dec 28, 2026 | in 6 mo | U-1946 |
| 8703780 | Dec 28, 2026 | in 6 mo | U-1491 |
| 8476284 | Dec 28, 2026 | in 6 mo | U-1946 |
| 8735403 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 7514444 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 8957079 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 9181257 | Dec 28, 2026 | in 6 mo | Substance |
| 8754091 | Dec 28, 2026 | in 6 mo | Product |
| 8697711 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 8563563 | Apr 26, 2027 | in 10 mo | U-2219 |
| 7514444*PED | Jun 28, 2027 | in 1 yr | |
| 8476284*PED | Jun 28, 2027 | in 1 yr | |
| 8497277*PED | Jun 28, 2027 | in 1 yr | |
| 8703780*PED | Jun 28, 2027 | in 1 yr | |
| 8735403*PED | Jun 28, 2027 | in 1 yr | |
| 8697711*PED | Jun 28, 2027 | in 1 yr | |
| 8754091*PED | Jun 28, 2027 | in 1 yr | |
| 8952015*PED | Jun 28, 2027 | in 1 yr | |
| 8957079*PED | Jun 28, 2027 | in 1 yr | |
| 9181257*PED | Jun 28, 2027 | in 1 yr | |
| 8563563*PED | Oct 26, 2027 | in 1 yr 4 mo | |
| 8008309 | Nov 13, 2027 | in 1 yr 5 mo | SubstanceProduct |
| 8008309*PED | May 13, 2028 | in 1 yr 11 mo | |
| 10004746 | Jun 03, 2031 | in 5 yr | U-2242 |
| 9801881 | Jun 03, 2031 | in 5 yr | U-1491 |
| 8999999 | Jun 03, 2031 | in 5 yr | U-2228 |
| 9801883 | Jun 03, 2031 | in 5 yr | U-2159 |
| 9125889 | Jun 03, 2031 | in 5 yr | U-1650 |
| 10016435 | Jun 03, 2031 | in 5 yr | U-1650 |
| 10478439 | Jun 03, 2031 | in 5 yr | U-1684 |
| 11672803 | Jun 03, 2031 | in 5 yr | U-2242 |
| 10751342 | Jun 03, 2031 | in 5 yr | U-1946 |
| 8754090 | Jun 03, 2031 | in 5 yr | U-1456 |
| 9814721 | Jun 03, 2031 | in 5 yr | U-1947 |
| 10653696 | Jun 03, 2031 | in 5 yr | U-1456 |
| 10004746*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 8999999*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 9125889*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 9801881*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 9801883*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 10016435*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 10751342*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 10478439*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 8754090*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 9814721*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 10653696*PED | Dec 03, 2031 | in 5 yr 6 mo | |
| 10961251 | Jun 03, 2033 | in 7 yr 1 mo | Product |
| 9713617 | Jun 03, 2033 | in 7 yr 1 mo | Product |
| 10294231 | Jun 03, 2033 | in 7 yr 1 mo | Product |
| 9725455 | Jun 03, 2033 | in 7 yr 1 mo | Substance |
| 10294232 | Jun 03, 2033 | in 7 yr 1 mo | Product |
| 10125140 | Jun 03, 2033 | in 7 yr 1 mo | SubstanceProduct |
| 10106548 | Jun 03, 2033 | in 7 yr 1 mo | SubstanceProduct |
| 10752634 | Jun 03, 2033 | in 7 yr 1 mo | Product |
| 9540382 | Aug 18, 2033 | in 7 yr 3 mo | U-1491 |
| 9296753 | Oct 30, 2033 | in 7 yr 6 mo | Substance |
| 9713617*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 9725455*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10106548*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10125140*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10294231*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10294232*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10961251*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 10752634*PED | Dec 03, 2033 | in 7 yr 7 mo | |
| 9540382*PED | Feb 18, 2034 | in 7 yr 9 mo | |
| 9296753*PED | Apr 30, 2034 | in 8 yr | |
| 10463668 | Oct 24, 2034 | in 8 yr 6 mo | U-2654 |
| 10695350 | Oct 24, 2034 | in 8 yr 6 mo | U-2846 |
| 9795604 | Oct 24, 2034 | in 8 yr 6 mo | U-3422 |
| 9795604*PED | Apr 24, 2035 | in 9 yr | |
| 10463668*PED | Apr 24, 2035 | in 9 yr | |
| 10695350*PED | Apr 24, 2035 | in 9 yr | |
| 10213386 | Mar 03, 2036 | in 9 yr 10 mo | Product |
| 9655857 | Mar 03, 2036 | in 9 yr 10 mo | Product |
| 12551448 | Mar 03, 2036 | in 9 yr 10 mo | Product |
| 10010507 | Mar 03, 2036 | in 9 yr 10 mo | Product |
| 10828259 | Mar 03, 2036 | in 9 yr 10 mo | Product |
| 12364698 | Apr 06, 2036 | in 9 yr 11 mo | Product |
| 9655857*PED | Sep 03, 2036 | in 10 yr 4 mo | |
| 10010507*PED | Sep 03, 2036 | in 10 yr 4 mo | |
| 10213386*PED | Sep 03, 2036 | in 10 yr 4 mo | |
| 10828259*PED | Sep 03, 2036 | in 10 yr 4 mo | |
| 12201690 | Jun 14, 2039 | in 13 yr 2 mo | Product |
Ibrutinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
