Home Applications 214621 Application 214621
Type NDA
Sponsor MYOVANT SCIENCES GMBH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORGOVYX RELUGOLIX TABLET;ORAL 120MG 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 N214621-001 ORGOVYX RELUGOLIX 120MG TABLET / ORAL RLD, RS 2020-12-18
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 N214621-001 12629370 2037-09-29 U-3020 2026-06-09
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 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214621-001 ORGOVYX 120MG TABLET / ORAL RLD, RS 2020-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 297 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 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214621-001 12629370 2037-09-29 U-3020 2026-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214621-001 12629370 2037-09-29 U-3020 2026-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10449191 2037-09-29 U-3020 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 10786501 2037-09-29 U-3020 2021-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 11583526 2037-09-29 U-3020 2023-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12097198 2037-09-29 U-3020 2024-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12144809 2037-09-29 U-4035 2024-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214621-001 12336990 2037-09-29 U-3020 2025-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 8058280 2026-01-28 Drug substance, Drug product 2021-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 7300935 2029-01-28 Drug substance 2021-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 11795178 2033-09-27 Drug substance, Drug product 2023-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 12325714 2033-09-27 Drug substance, Drug product 2025-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214621-001 10350170 2036-02-25 Drug product 2021-01-14 31067a03dcf5…
Observed Orange Book exclusivity history# 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72974-120 Orgovyx relugolix Myovant Sciences, Inc. NDA Current 72974-120 Orgovyx relugolix Myovant Sciences, Inc. NDA Current 72974-120 Orgovyx relugolix Myovant Sciences, Inc. NDA Current 72974-120 Orgovyx relugolix Myovant Sciences, Inc. NDA Current 72974-120 Orgovyx relugolix Myovant Sciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 83702 SUPPL 2025-10-09 83697 SUPPL 2025-10-09 79941 SUPPL 2024-10-21 79922 SUPPL 2024-10-21 73916 SUPPL 2023-03-31 73909 SUPPL 2023-03-31 65866 ORIG 2021-01-07 65712 ORIG 2020-12-23 65622 ORIG 2020-12-18