Home Applications 213006 Application 213006
Type NDA
Sponsor UROVANT SCIENCES GMBH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GEMTESA VIBEGRON TABLET;ORAL 75MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213006-001 GEMTESA VIBEGRON 75MG TABLET / ORAL RLD, RS 2020-12-23
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 N213006-001 12357636 2042-07-06 U-4219 2025-07-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213006-001 I-955 2027-12-18
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.
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 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 105 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 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12357636 2042-05-04 U-4219 2025-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12357636 2042-05-04 U-4219 2025-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73336-075 GEMTESA vibegron Urovant Sciences, Inc. NDA Current 73336-075 GEMTESA vibegron Urovant Sciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81300 SUPPL 2024-12-19 80636 SUPPL 2024-12-19 79845 SUPPL 2024-12-19 79851 SUPPL 2024-10-10 65934 ORIG 2021-01-19 65762 ORIG 2020-12-28 65733 ORIG 2020-12-23