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- Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
- Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
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Patent and Exclusivity for: N205552
Product 001
IBRUTINIB (IMBRUVICA) CAPSULE 140MG
Patent Data
| Product No | Patent No | Patent Expiration | Drug Substance | Drug Product | Patent Use Code | Delist Requested | Submission Date |
|---|---|---|---|---|---|---|---|
| 001 | 7514444 | 12/28/2026 | DS | DP | 12/12/2013 | ||
| 001 | 7514444*PED | 06/28/2027 | |||||
| 001 | 8008309 | 11/13/2027 | DS | DP | 12/12/2013 | ||
| 001 | 8008309*PED | 05/13/2028 | |||||
| 001 | 8476284 | 12/28/2026 | U-1650 U-1946 | 12/12/2013 | |||
| 001 | 8476284*PED | 06/28/2027 | |||||
| 001 | 8497277 | 12/28/2026 | U-1491 U-1650 U-1946 U-2241 U-2242 U-3422 | 12/12/2013 | |||
| 001 | 8497277*PED | 06/28/2027 | |||||
| 001 | 8563563 | 04/26/2027 | U-1491 U-1650 U-1946 U-2219 | 01/19/2018 | |||
| 001 | 8563563*PED | 10/26/2027 | |||||
| 001 | 8697711 | 12/28/2026 | DS | DP | 05/13/2014 | ||
| 001 | 8697711*PED | 06/28/2027 | |||||
| 001 | 8703780 | 12/28/2026 | U-1491 | 05/13/2014 | |||
| 001 | 8703780*PED | 06/28/2027 | |||||
| 001 | 8735403 | 12/28/2026 | DS | DP | 06/18/2014 | ||
| 001 | 8735403*PED | 06/28/2027 | |||||
| 001 | 8754091 | 12/28/2026 | DP | 07/01/2014 | |||
| 001 | 8754091*PED | 06/28/2027 | |||||
| 001 | 8952015 | 12/28/2026 | U-1491 U-1650 U-1946 | 09/01/2017 | |||
| 001 | 8952015*PED | 06/28/2027 | |||||
| 001 | 8957079 | 12/28/2026 | DS | DP | 03/16/2015 | ||
| 001 | 8957079*PED | 06/28/2027 | |||||
| 001 | 8999999 | 06/03/2031 | U-1683 U-1684 | 04/28/2015 | |||
| 001 | 8999999*PED | 12/03/2031 | |||||
| 001 | 9125889 | 06/03/2031 | U-1745 | 09/25/2015 | |||
| 001 | 9125889*PED | 12/03/2031 | |||||
| 001 | 9181257 | 12/28/2026 | DS | DP | 12/08/2015 | ||
| 001 | 9181257*PED | 06/28/2027 | |||||
| 001 | 9296753 | 10/30/2033 | DS | DP | 04/18/2016 | ||
| 001 | 9296753*PED | 04/30/2034 | |||||
| 001 | 9540382 | 08/18/2033 | U-1650 U-1684 U-1946 | 01/30/2017 | |||
| 001 | 9540382*PED | 02/18/2034 | |||||
| 001 | 9713617 | 06/03/2033 | DP | 08/28/2017 | |||
| 001 | 9713617*PED | 12/03/2033 | |||||
| 001 | 9725455 | 06/03/2033 | DS | 08/28/2017 | |||
| 001 | 9725455*PED | 12/03/2033 | |||||
| 001 | 9795604 | 10/24/2034 | U-2150 U-2969 U-2970 U-3422 | 10/27/2017 | |||
| 001 | 9795604*PED | 04/24/2035 | |||||
| 001 | 9801881 | 06/03/2031 | U-1491 | 11/06/2017 | |||
| 001 | 9801881*PED | 12/03/2031 | |||||
| 001 | 9801883 | 06/03/2031 | U-2159 | 11/06/2017 | |||
| 001 | 9801883*PED | 12/03/2031 | |||||
| 001 | 10004746 | 06/03/2031 | U-1684 U-1946 U-2241 U-2242 | 07/16/2018 | |||
| 001 | 10004746*PED | 12/03/2031 | |||||
| 001 | 10016435 | 06/03/2031 | U-1650 | 08/03/2018 | |||
| 001 | 10016435*PED | 12/03/2031 | |||||
| 001 | 10106548 | 06/03/2033 | DS | DP | 10/26/2018 | ||
| 001 | 10106548*PED | 12/03/2033 | |||||
| 001 | 10125140 | 06/03/2033 | DS | DP | 11/16/2018 | ||
| 001 | 10125140*PED | 12/03/2033 | |||||
| 001 | 10294231 | 06/03/2033 | DP | 05/23/2019 | |||
| 001 | 10294231*PED | 12/03/2033 | |||||
| 001 | 10294232 | 06/03/2033 | DP | 05/23/2019 | |||
| 001 | 10294232*PED | 12/03/2033 | |||||
| 001 | 10463668 | 10/24/2034 | U-2654 | 11/20/2019 | |||
| 001 | 10463668*PED | 04/24/2035 | |||||
| 001 | 10478439 | 06/03/2031 | U-1650 U-1684 U-1946 U-2241 U-2242 U-2665 U-3422 | 12/10/2019 | |||
| 001 | 10478439*PED | 12/03/2031 | |||||
| 001 | 10695350 | 10/24/2034 | U-2846 | 07/14/2020 | |||
| 001 | 10695350*PED | 04/24/2035 | |||||
| 001 | 10751342 | 06/03/2031 | U-1491 U-1946 U-2943 U-2944 | 09/10/2020 | |||
| 001 | 10751342*PED | 12/03/2031 | |||||
| 001 | 10752634 | 06/03/2033 | DP | 09/10/2020 | |||
| 001 | 10752634*PED | 12/03/2033 | |||||
| 001 | 10961251 | 06/03/2033 | DP | 04/16/2021 | |||
| 001 | 10961251*PED | 12/03/2033 | |||||
| 001 | 11672803 | 06/03/2031 | U-1684 U-1946 U-2241 U-2242 | 07/14/2023 |
Exclusivity Data
| Product No | Exclusivity Code | Exclusivity Expiration |
|---|---|---|
| 001 | ODE-152 | 08/02/2024 |
| 001 | ODE-152 *PED | 02/02/2025 |
| 001 | M-14 | 08/24/2025 |
| 001 | NPP | 08/24/2025 |
| 001 | NPP *PED | 02/24/2026 |
| 001 | ODE-405 | 08/24/2029 |
| 001 | ODE-405 *PED | 02/24/2030 |
View a list of all patent use codes
View a list of all exclusivity codes