Home NDC 15054-0080 IQIRVO
Product NDC 15054-0080
11-digit product format 150540080
Labeler code 15054
Product ID 15054-0080_c77d04f1-9e73-4cde-9ab3-bac12d595fc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name elafibranor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ipsen Biopharmaceuticals, Inc.
Application NDA218860
Marketing category NDA
Marketing start 2024-06-10
Substance ELAFIBRANOR
Active strength 80 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Peroxisome Proliferator-activated Receptor Agonist [EPC], Peroxisome Proliferator-activated Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 N218860-001 IQIRVO ELAFIBRANOR 80MG TABLET / ORAL RLD, RS 2024-06-10
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218860-001 11185519 2037-03-30 U-3955 2024-06-25 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 N218860-001 12233038 2037-03-30 U-1854 2025-03-12 N218860-001 12295927 2037-03-30 U-1854 2025-06-03 N218860-001 12295928 2037-03-30 U-1854 2025-06-03 N218860-001 12310935 2037-03-30 U-1854 2025-06-03 N218860-001 12589086 2037-03-30 U-4473 2026-04-09 N218860-001 12673035 2044-03-05 U-1854 Drug product 2026-08-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218860-001 NCE 2029-06-10 N218860-001 ODE-486 2031-06-10
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 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218860-001 IQIRVO 80MG TABLET / ORAL RLD, RS 2024-06-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 104 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 N218860-001 11185519 2037-03-30 U-3955 2024-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12233038 2037-03-30 U-1854 2025-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12295927 2037-03-30 U-1854 2025-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12295928 2037-03-30 U-1854 2025-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12310935 2037-03-30 U-1854 2025-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12589086 2037-03-30 U-4473 2026-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218860-001 12673035 2044-03-05 U-1854 Drug product 2026-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218860-001 11185519 2037-03-30 U-3955 2024-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12233038 2037-03-30 U-1854 2025-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12295927 2037-03-30 U-1854 2025-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12295928 2037-03-30 U-1854 2025-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12310935 2037-03-30 U-1854 2025-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12589086 2037-03-30 U-4473 2026-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218860-001 12673035 2044-03-05 U-1854 Drug product 2026-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218860-001 11185519 2037-03-30 U-3955 2024-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 12233038 2037-03-30 U-1854 2025-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 12295927 2037-03-30 U-1854 2025-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 12295928 2037-03-30 U-1854 2025-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218860-001 12310935 2037-03-30 U-1854 2025-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 11185519 2037-03-30 U-3955 2024-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 12233038 2037-03-30 U-1854 2025-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 12295927 2037-03-30 U-1854 2025-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 12295928 2037-03-30 U-1854 2025-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218860-001 12310935 2037-03-30 U-1854 2025-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218860-001 11185519 2037-03-30 U-3955 2024-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218860-001 11331292 2037-03-30 U-1854 2024-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218860-001 11850223 2037-03-30 U-1854 2024-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218860-001 11857523 2037-03-30 U-3955 2024-06-25 6a471c1ec25d…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IQIRVO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELAFIBRANOR 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2J3H5C81A5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2684946 Internal RxNorm lookup 2684952 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 15054-0080-1 IQIRVO 30 in 1 BOTTLE TABLET, FILM COATED 30 3 15054-0080-1 IQIRVO 1 in 1 CARTON TABLET, FILM COATED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15054-0080 IQIRVO (ELAFIBRANOR) TABLET, FILM COATED [IPSEN BIOPHARMACEUTICALS, INC.] 3 Current NDC, 2 package rows 20240613_d78aa14f-6ec1-4b1d-a4ae-e48658137a25.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 15054-0080-1 15054008001 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-06-10 No No Current