Home Applications 205123 Application 205123
Type NDA
Sponsor JANSSEN PRODS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OLYSIO SIMEPREVIR SODIUM CAPSULE;ORAL EQ 150MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N205123-001 OLYSIO SIMEPREVIR SODIUM EQ 150MG BASE CAPSULE / ORAL RLD 2013-11-22
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 N205123-001 8148399 2029-09-05 U-1467 Drug substance, Drug product
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N205123-001 OLYSIO EQ 150MG BASE CAPSULE / ORAL RLD 2013-11-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205123-001 OLYSIO EQ 150MG BASE CAPSULE / ORAL RLD 2013-11-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205123-001 OLYSIO EQ 150MG BASE CAPSULE / ORAL RLD 2013-11-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205123-001 OLYSIO EQ 150MG BASE CAPSULE / ORAL RLD 2013-11-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 391 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205123-001 8148399 2029-09-05 U-1467 Drug substance, Drug product c2088c7a36db…2026-09-14 22:38:34 2026-08 N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205123-001 8148399 2029-09-05 U-1467 Drug substance, Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205123-001 8148399 2029-09-05 U-1467 Drug substance, Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205123-001 8148399 2029-09-05 U-1467 Drug substance, Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 7671032 2025-05-19 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 8349869 2026-07-28 U-1467 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 8741926 2026-07-28 U-1467 Drug substance 2014-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 8754106 2026-07-28 U-1467 Drug substance 2014-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 9040562 2026-07-28 U-1467 Drug substance, Drug product 2015-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 9353103 2026-07-28 U-1467 2016-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 9623022 2026-07-28 U-1467 2017-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205123-001 9856265 2026-07-28 U-1467 Drug substance, Drug product 2018-02-01 31067a03dcf5…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.