Home Applications 208716 Application 208716
Type NDA
Sponsor ELI LILLY AND CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERZENIO ABEMACICLIB TABLET;ORAL 50MG Yes No 002 VERZENIO ABEMACICLIB TABLET;ORAL 100MG Yes No 003 VERZENIO ABEMACICLIB TABLET;ORAL 150MG Yes No 004 VERZENIO ABEMACICLIB TABLET;ORAL 200MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208716-001 VERZENIO ABEMACICLIB 50MG TABLET / ORAL RLD 2017-09-28 N208716-002 VERZENIO ABEMACICLIB 100MG TABLET / ORAL RLD 2017-09-28 N208716-003 VERZENIO ABEMACICLIB 150MG TABLET / ORAL RLD 2017-09-28 N208716-004 VERZENIO ABEMACICLIB 200MG TABLET / ORAL RLD, RS 2017-09-28
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208716-001 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 N208716-001 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 N208716-001 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 N208716-001 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 N208716-002 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 N208716-002 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 N208716-002 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 N208716-002 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 N208716-003 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 N208716-003 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 N208716-003 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 N208716-003 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 N208716-004 7855211 2031-09-28 U-1981 Drug substance, Drug product 2017-10-16 N208716-004 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 N208716-004 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 N208716-004 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 N208716-004 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208716-001 VERZENIO 50MG TABLET / ORAL RLD 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208716-002 VERZENIO 100MG TABLET / ORAL RLD 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208716-003 VERZENIO 150MG TABLET / ORAL RLD 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208716-004 VERZENIO 200MG TABLET / ORAL RLD, RS 2017-09-28 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 23 · 881 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208716-001 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-001 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-001 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-001 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-002 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-002 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-002 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-002 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-003 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-003 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-003 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-003 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 7855211 2031-09-28 U-1981 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208716-004 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208716-001 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-001 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-001 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-001 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-002 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-002 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-002 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-002 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-003 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-003 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-003 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-003 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 7855211 2031-09-28 U-1981 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208716-004 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208716-001 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-001 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-001 7855211 2031-09-28 U-3265 Drug substance, Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-001 7855211 2031-09-28 U-3242 Drug substance, Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-002 7855211 2031-09-28 U-2135 Drug substance, Drug product 2017-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208716-002 7855211 2031-09-28 U-3546 Drug substance, Drug product 2017-10-16 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 9 · 324 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 NDC Name Nonproprietary name Labeler Marketing category Status 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4483 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-4815 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-5337 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current 0002-6216 Verzenio abemaciclib Eli Lilly and Company NDA Current