Application 208716

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERZENIOABEMACICLIBTABLET;ORAL50MGYesNo
002VERZENIOABEMACICLIBTABLET;ORAL100MGYesNo
003VERZENIOABEMACICLIBTABLET;ORAL150MGYesNo
004VERZENIOABEMACICLIBTABLET;ORAL200MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208716-001VERZENIOABEMACICLIB50MGTABLET / ORALRLD2017-09-28
N208716-002VERZENIOABEMACICLIB100MGTABLET / ORALRLD2017-09-28
N208716-003VERZENIOABEMACICLIB150MGTABLET / ORALRLD2017-09-28
N208716-004VERZENIOABEMACICLIB200MGTABLET / ORALRLD, RS2017-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208716-00178552112031-09-28U-2135Drug substance, Drug product2017-10-16
N208716-00178552112031-09-28U-3242Drug substance, Drug product2017-10-16
N208716-00178552112031-09-28U-3265Drug substance, Drug product2017-10-16
N208716-00178552112031-09-28U-3546Drug substance, Drug product2017-10-16
N208716-00278552112031-09-28U-2135Drug substance, Drug product2017-10-16
N208716-00278552112031-09-28U-3242Drug substance, Drug product2017-10-16
N208716-00278552112031-09-28U-3265Drug substance, Drug product2017-10-16
N208716-00278552112031-09-28U-3546Drug substance, Drug product2017-10-16
N208716-00378552112031-09-28U-2135Drug substance, Drug product2017-10-16
N208716-00378552112031-09-28U-3242Drug substance, Drug product2017-10-16
N208716-00378552112031-09-28U-3265Drug substance, Drug product2017-10-16
N208716-00378552112031-09-28U-3546Drug substance, Drug product2017-10-16
N208716-00478552112031-09-28U-1981Drug substance, Drug product2017-10-16
N208716-00478552112031-09-28U-2135Drug substance, Drug product2017-10-16
N208716-00478552112031-09-28U-3242Drug substance, Drug product2017-10-16
N208716-00478552112031-09-28U-3265Drug substance, Drug product2017-10-16
N208716-00478552112031-09-28U-3546Drug substance, Drug product2017-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-2884e616aacf4f…
2026-08-18 06:07:402026-07N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208716-001VERZENIO50MGTABLET / ORALRLD2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208716-002VERZENIO100MGTABLET / ORALRLD2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208716-003VERZENIO150MGTABLET / ORALRLD2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208716-004VERZENIO200MGTABLET / ORALRLD, RS2017-09-285bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 23 · 881 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208716-00178552112031-09-28U-2135Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00178552112031-09-28U-3546Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00178552112031-09-28U-3265Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00178552112031-09-28U-3242Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00278552112031-09-28U-2135Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00278552112031-09-28U-3546Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00278552112031-09-28U-3265Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00278552112031-09-28U-3242Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00378552112031-09-28U-2135Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00378552112031-09-28U-3546Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00378552112031-09-28U-3265Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00378552112031-09-28U-3242Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00478552112031-09-28U-1981Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00478552112031-09-28U-2135Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00478552112031-09-28U-3265Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00478552112031-09-28U-3546Drug substance, Drug product2017-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N208716-00478552112031-09-28U-3242Drug substance, Drug product2017-10-1684e616aacf4f…
2026-08-18 06:07:402026-07N208716-00178552112031-09-28U-2135Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00178552112031-09-28U-3546Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00178552112031-09-28U-3265Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00178552112031-09-28U-3242Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00278552112031-09-28U-2135Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00278552112031-09-28U-3546Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00278552112031-09-28U-3265Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00278552112031-09-28U-3242Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00378552112031-09-28U-2135Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00378552112031-09-28U-3546Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00378552112031-09-28U-3265Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00378552112031-09-28U-3242Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00478552112031-09-28U-1981Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00478552112031-09-28U-2135Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00478552112031-09-28U-3265Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00478552112031-09-28U-3546Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208716-00478552112031-09-28U-3242Drug substance, Drug product2017-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208716-00178552112031-09-28U-2135Drug substance, Drug product2017-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-00178552112031-09-28U-3546Drug substance, Drug product2017-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-00178552112031-09-28U-3265Drug substance, Drug product2017-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-00178552112031-09-28U-3242Drug substance, Drug product2017-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-00278552112031-09-28U-2135Drug substance, Drug product2017-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208716-00278552112031-09-28U-3546Drug substance, Drug product2017-10-16011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 9 · 324 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-03-09 01:35 UTC2022-03N208716-002I-8772024-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-002NPP2024-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-003NCE2022-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-003I-8772024-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-003NPP2024-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-004NCE2022-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-004I-8772024-10-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N208716-004NPP2024-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208716-001I-7682021-02-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-001NCE2022-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-001I-8772024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-001NPP2024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-002I-7682021-02-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-002NCE2022-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-002I-8772024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-002NPP2024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-003I-7682021-02-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-003NCE2022-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-003I-8772024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-003NPP2024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-004I-7682021-02-26782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-004NCE2022-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-004I-8772024-10-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N208716-004NPP2024-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-001I-7682021-02-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-001NCE2022-09-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-002I-7682021-02-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-002NCE2022-09-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-003I-7682021-02-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-003NCE2022-09-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-004I-7682021-02-2687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208716-004NCE2022-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N208716-001I-7682021-02-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-001NCE2022-09-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-002I-7682021-02-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-002NCE2022-09-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-003I-7682021-02-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-003NCE2022-09-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-004I-7682021-02-265aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208716-004NCE2022-09-285aa47cf7b7d7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4483VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-4815VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-5337VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent
0002-6216VerzenioabemaciclibEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81385SUPPL 2025-03-03
81381SUPPL 2025-02-28
80215SUPPL 2024-11-14
80213SUPPL 2024-11-14
73682SUPPL 2023-03-06
73681SUPPL 2023-03-06
73674SUPPL 2023-03-03
73673SUPPL 2023-03-03
68982SUPPL2021-10-14
68981SUPPL2021-10-14
68980SUPPL2021-10-14
68967SUPPL2021-10-13
68966SUPPL2021-10-13
68965SUPPL2021-10-13
62406SUPPL2020-04-01
62394SUPPL2020-03-31
59972SUPPL2019-09-11
59957SUPPL2019-09-09
55257SUPPL2018-08-21
55214SUPPL2018-08-20
50236ORIG2017-10-31
49891ORIG2017-09-28
49872ORIG2017-09-28