ibrutinib · Pharmacyclics Llc · NDA 205552, 210563, 217003
Imbruvica
Earliest generic entry, as listed · earliest of 6 marketed strengths
24 Apr 2035
Other strengths are listed to 14 Jun 2039.
Blocked by patent: US 10463668, US 10695350, US 9795604.
Listed patents · 192 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12201690 | product | 14 Jun 2039 |
| US 10010507 | — | 3 Sep 2036 |
| US 10213386 | — | 3 Sep 2036 |
| US 10828259 | — | 3 Sep 2036 |
| US 9655857 | — | 3 Sep 2036 |
| US 12364698 | product | 6 Apr 2036 |
| US 10010507 | product | 3 Mar 2036 |
| US 10213386 | product | 3 Mar 2036 |
| US 10828259 | product | 3 Mar 2036 |
| US 12551448 | product | 3 Mar 2036 |
| US 9655857 | product | 3 Mar 2036 |
| US 10463668 | — | 24 Apr 2035 |
| US 10695350 | — | 24 Apr 2035 |
| US 9795604 | — | 24 Apr 2035 |
| US 10463668 | use U-2654 | 24 Oct 2034 |
| US 10463668 | use U-2970 | 24 Oct 2034 |
| US 10695350 | use U-2846 | 24 Oct 2034 |
| US 10695350 | use U-2970 | 24 Oct 2034 |
| US 9795604 | use U-2969 | 24 Oct 2034 |
| US 9795604 | use U-2970 | 24 Oct 2034 |
| US 9795604 | use U-3422 | 24 Oct 2034 |
| US 9795604 | use U-2150 | 24 Oct 2034 |
| US 9296753 | — | 30 Apr 2034 |
| US 9540382 | — | 18 Feb 2034 |
| US 10106548 | — | 3 Dec 2033 |
| US 10125140 | — | 3 Dec 2033 |
| US 10294231 | — | 3 Dec 2033 |
| US 10294232 | — | 3 Dec 2033 |
| US 10752634 | — | 3 Dec 2033 |
| US 10961251 | — | 3 Dec 2033 |
| US 9713617 | — | 3 Dec 2033 |
| US 9725455 | — | 3 Dec 2033 |
| US 9296753 | substance | 30 Oct 2033 |
| US 9540382 | use U-1684 | 18 Aug 2033 |
| US 9540382 | use U-1650 | 18 Aug 2033 |
| US 9540382 | use U-1491 | 18 Aug 2033 |
| US 9540382 | use U-1946 | 18 Aug 2033 |
| US 10106548 | substance, product | 3 Jun 2033 |
| US 10125140 | substance, product | 3 Jun 2033 |
| US 10294231 | product | 3 Jun 2033 |
| US 10294232 | product | 3 Jun 2033 |
| US 10752634 | product | 3 Jun 2033 |
| US 10961251 | product | 3 Jun 2033 |
| US 9713617 | product | 3 Jun 2033 |
| US 9725455 | substance | 3 Jun 2033 |
| US 10004746 | — | 3 Dec 2031 |
| US 10016435 | — | 3 Dec 2031 |
| US 10478439 | — | 3 Dec 2031 |
| US 10653696 | — | 3 Dec 2031 |
| US 10751342 | — | 3 Dec 2031 |
| US 8754090 | — | 3 Dec 2031 |
| US 8999999 | — | 3 Dec 2031 |
| US 9125889 | — | 3 Dec 2031 |
| US 9801881 | — | 3 Dec 2031 |
| US 9801883 | — | 3 Dec 2031 |
| US 9814721 | — | 3 Dec 2031 |
| US 10004746 | use U-1946 | 3 Jun 2031 |
| US 10004746 | use U-2241 | 3 Jun 2031 |
| US 10004746 | use U-1684 | 3 Jun 2031 |
| US 10004746 | use U-2242 | 3 Jun 2031 |
| US 10004746 | use U-3846 | 3 Jun 2031 |
| US 10004746 | use U-3848 | 3 Jun 2031 |
| US 10004746 | use U-3849 | 3 Jun 2031 |
| US 10004746 | use U-3847 | 3 Jun 2031 |
| US 10016435 | use U-3845 | 3 Jun 2031 |
| US 10016435 | use U-1650 | 3 Jun 2031 |
| US 10478439 | use U-2970 | 3 Jun 2031 |
| US 10478439 | use U-2242 | 3 Jun 2031 |
| US 10478439 | use U-1946 | 3 Jun 2031 |
| US 10478439 | use U-1650 | 3 Jun 2031 |
| US 10478439 | use U-1947 | 3 Jun 2031 |
| US 10478439 | use U-1456 | 3 Jun 2031 |
| US 10478439 | use U-2241 | 3 Jun 2031 |
| US 10478439 | use U-2665 | 3 Jun 2031 |
| US 10478439 | use U-1684 | 3 Jun 2031 |
| US 10478439 | use U-3422 | 3 Jun 2031 |
| US 10478439 | use U-3842 | 3 Jun 2031 |
| US 10478439 | use U-3844 | 3 Jun 2031 |
| US 10478439 | use U-2666 | 3 Jun 2031 |
| US 10478439 | use U-3843 | 3 Jun 2031 |
| US 10478439 | use U-3845 | 3 Jun 2031 |
| US 10653696 | use U-1456 | 3 Jun 2031 |
| US 10751342 | use U-2944 | 3 Jun 2031 |
| US 10751342 | use U-1946 | 3 Jun 2031 |
| US 10751342 | use U-2943 | 3 Jun 2031 |
| US 10751342 | use U-2666 | 3 Jun 2031 |
| US 10751342 | use U-3844 | 3 Jun 2031 |
| US 10751342 | use U-3843 | 3 Jun 2031 |
| US 10751342 | use U-3842 | 3 Jun 2031 |
| US 10751342 | use U-1491 | 3 Jun 2031 |
| US 11672803 | use U-1946 | 3 Jun 2031 |
| US 11672803 | use U-1684 | 3 Jun 2031 |
| US 11672803 | use U-2241 | 3 Jun 2031 |
| US 11672803 | use U-2242 | 3 Jun 2031 |
| US 11672803 | use U-3843 | 3 Jun 2031 |
| US 11672803 | use U-3844 | 3 Jun 2031 |
| US 11672803 | use U-3842 | 3 Jun 2031 |
| US 11672803 | use U-2666 | 3 Jun 2031 |
| US 8754090 | use U-1456 | 3 Jun 2031 |
| US 8999999 | use U-2242 | 3 Jun 2031 |
| US 8999999 | use U-2241 | 3 Jun 2031 |
| US 8999999 | use U-1491 | 3 Jun 2031 |
| US 8999999 | use U-1946 | 3 Jun 2031 |
| US 8999999 | use U-2228 | 3 Jun 2031 |
| US 8999999 | use U-1683 | 3 Jun 2031 |
| US 8999999 | use U-3844 | 3 Jun 2031 |
| US 8999999 | use U-2666 | 3 Jun 2031 |
| US 8999999 | use U-3842 | 3 Jun 2031 |
| US 8999999 | use U-3843 | 3 Jun 2031 |
| US 8999999 | use U-1684 | 3 Jun 2031 |
| US 9125889 | use U-1745 | 3 Jun 2031 |
| US 9125889 | use U-1650 | 3 Jun 2031 |
| US 9125889 | use U-3845 | 3 Jun 2031 |
| US 9801881 | use U-3846 | 3 Jun 2031 |
| US 9801881 | use U-1491 | 3 Jun 2031 |
| US 9801881 | use U-3847 | 3 Jun 2031 |
| US 9801881 | use U-2242 | 3 Jun 2031 |
| US 9801883 | use U-2159 | 3 Jun 2031 |
| US 9801883 | use U-2243 | 3 Jun 2031 |
| US 9801883 | use U-2666 | 3 Jun 2031 |
| US 9801883 | use U-3842 | 3 Jun 2031 |
| US 9801883 | use U-3844 | 3 Jun 2031 |
| US 9801883 | use U-3843 | 3 Jun 2031 |
| US 9814721 | use U-1947 | 3 Jun 2031 |
| US 8008309 | — | 13 May 2028 |
| US 8008309 | substance, product | 13 Nov 2027 |
| US 8563563 | — | 26 Oct 2027 |
| US 7514444 | — | 28 Jun 2027 |
| US 8476284 | — | 28 Jun 2027 |
| US 8497277 | — | 28 Jun 2027 |
| US 8697711 | — | 28 Jun 2027 |
| US 8703780 | — | 28 Jun 2027 |
| US 8735403 | — | 28 Jun 2027 |
| US 8754091 | — | 28 Jun 2027 |
| US 8952015 | — | 28 Jun 2027 |
| US 8957079 | — | 28 Jun 2027 |
| US 9181257 | — | 28 Jun 2027 |
| US 8563563 | use U-2219 | 26 Apr 2027 |
| US 8563563 | use U-1946 | 26 Apr 2027 |
| US 8563563 | use U-1491 | 26 Apr 2027 |
| US 8563563 | use U-2241 | 26 Apr 2027 |
| US 8563563 | use U-1650 | 26 Apr 2027 |
| US 8563563 | use U-3844 | 26 Apr 2027 |
| US 8563563 | use U-3843 | 26 Apr 2027 |
| US 8563563 | use U-3842 | 26 Apr 2027 |
| US 8563563 | use U-2666 | 26 Apr 2027 |
| US 8563563 | use U-3845 | 26 Apr 2027 |
| US 8563563 | use U-2242 | 26 Apr 2027 |
| US 7514444 | substance, product | 28 Dec 2026 |
| US 8476284 | use U-1947 | 28 Dec 2026 |
| US 8476284 | use U-1650 | 28 Dec 2026 |
| US 8476284 | use U-2241 | 28 Dec 2026 |
| US 8476284 | use U-1946 | 28 Dec 2026 |
| US 8476284 | use U-3843 | 28 Dec 2026 |
| US 8476284 | use U-3844 | 28 Dec 2026 |
| US 8476284 | use U-3845 | 28 Dec 2026 |
| US 8476284 | use U-1456 | 28 Dec 2026 |
| US 8497277 | use U-3843 | 28 Dec 2026 |
| US 8497277 | use U-1946 | 28 Dec 2026 |
| US 8497277 | use U-1491 | 28 Dec 2026 |
| US 8497277 | use U-2970 | 28 Dec 2026 |
| US 8497277 | use U-2666 | 28 Dec 2026 |
| US 8497277 | use U-3844 | 28 Dec 2026 |
| US 8497277 | use U-3845 | 28 Dec 2026 |
| US 8497277 | use U-2242 | 28 Dec 2026 |
| US 8497277 | use U-3842 | 28 Dec 2026 |
| US 8497277 | use U-1650 | 28 Dec 2026 |
| US 8497277 | use U-2241 | 28 Dec 2026 |
| US 8497277 | use U-1947 | 28 Dec 2026 |
| US 8497277 | use U-3422 | 28 Dec 2026 |
| US 8497277 | use U-1456 | 28 Dec 2026 |
| US 8697711 | substance, product | 28 Dec 2026 |
| US 8703780 | use U-2242 | 28 Dec 2026 |
| US 8703780 | use U-1491 | 28 Dec 2026 |
| US 8703780 | use U-3842 | 28 Dec 2026 |
| US 8703780 | use U-2666 | 28 Dec 2026 |
| US 8735403 | substance, product | 28 Dec 2026 |
| US 8754091 | product | 28 Dec 2026 |
| US 8952015 | use U-1650 | 28 Dec 2026 |
| US 8952015 | use U-1491 | 28 Dec 2026 |
| US 8952015 | use U-2242 | 28 Dec 2026 |
| US 8952015 | use U-1946 | 28 Dec 2026 |
| US 8952015 | use U-2241 | 28 Dec 2026 |
| US 8952015 | use U-3845 | 28 Dec 2026 |
| US 8952015 | use U-3844 | 28 Dec 2026 |
| US 8952015 | use U-3843 | 28 Dec 2026 |
| US 8952015 | use U-3842 | 28 Dec 2026 |
| US 8952015 | use U-2666 | 28 Dec 2026 |
| US 8952015 | use U-1947 | 28 Dec 2026 |
| US 8952015 | use U-1456 | 28 Dec 2026 |
| US 8957079 | substance, product | 28 Dec 2026 |
| US 9181257 | substance, product | 28 Dec 2026 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 24 Feb 2030 |
| ODE-405 | orphan drug (7 years) | 24 Aug 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 205552-0018 Sep 2026
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205552 · 001 · RLD | capsule, oral | 140MG | 24 Apr 2035 |
| 205552 · 002 · RLD | capsule, oral | 70MG | 24 Apr 2035 |
| 210563 · 001 · RLD | tablet, oral | 140MG | 3 Sep 2036 |
| 210563 · 002 · RLD | tablet, oral | 280MG | 3 Sep 2036 |
| 210563 · 003 · RLD | tablet, oral | 420MG | 3 Sep 2036 |
| 210563 · 004 · RLD · discontinued | tablet, oral | 560MG | 3 Sep 2036 |
| 217003 · 001 · RLD | suspension, oral | 70MG/ML | 14 Jun 2039 |
Expired or delisted (3)
- PED · 24 Feb 2026
- NPP · 24 Aug 2025
- NP · 24 Aug 2025