Application 208780

Type: NDA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESBRIET	PIRFENIDONE	TABLET;ORAL	267MG	Yes	No
002	ESBRIET	PIRFENIDONE	TABLET;ORAL	534MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ESBRIET	PIRFENIDONE	TABLET;ORAL	801MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208780-001	ESBRIET	PIRFENIDONE	267MG	TABLET / ORAL	AB	RLD	2017-01-11
N208780-002	ESBRIET	PIRFENIDONE	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11
N208780-003	ESBRIET	PIRFENIDONE	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N208780-001	AB
N208780-003	AB

Orange Book patents#

Current patent rows page 1 of 2 · 129 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208780-001	7767700	2027-12-18	U-2080		2017-02-10
N208780-001	8420674	2027-12-18	U-2079		2017-02-10
N208780-001	8383150	2028-05-10	U-2361	Drug product	2017-02-10
N208780-001	7566729	2029-04-22	U-2077		2017-02-10
N208780-001	7566729	2029-04-22	U-2078		2017-02-10
N208780-001	7635707	2029-04-22	U-2072		2017-02-10
N208780-001	7635707	2029-04-22	U-2073		2017-02-10
N208780-001	7635707	2029-04-22	U-2074		2017-02-10
N208780-001	7635707	2029-04-22	U-2075		2017-02-10
N208780-001	7635707	2029-04-22	U-2076		2017-02-10
N208780-001	7635707	2029-04-22	U-2083		2017-02-10
N208780-001	8592462	2029-04-22	U-2055		2017-02-10
N208780-001	8592462	2029-04-22	U-2056		2017-02-10
N208780-001	8592462	2029-04-22	U-2057		2017-02-10
N208780-001	8592462	2029-04-22	U-2058		2017-02-10
N208780-001	8592462	2029-04-22	U-2059		2017-02-10
N208780-001	8592462	2029-04-22	U-2060		2017-02-10
N208780-001	8592462	2029-04-22	U-2061		2017-02-10
N208780-001	8592462	2029-04-22	U-2062		2017-02-10
N208780-001	8592462	2029-04-22	U-2063		2017-02-10
N208780-001	8609701	2029-04-22	U-2064		2017-02-10
N208780-001	8609701	2029-04-22	U-2065		2017-02-10
N208780-001	8609701	2029-04-22	U-2066		2017-02-10
N208780-001	8609701	2029-04-22	U-2067		2017-02-10
N208780-001	8609701	2029-04-22	U-2068		2017-02-10
N208780-001	8609701	2029-04-22	U-2069		2017-02-10
N208780-001	8609701	2029-04-22	U-2070		2017-02-10
N208780-001	7816383	2030-01-08	U-2042		2017-02-10
N208780-001	7816383	2030-01-08	U-2050		2017-02-10
N208780-001	7910610	2030-01-08	U-2048		2017-02-10
N208780-001	7910610	2030-01-08	U-2049		2017-02-10
N208780-001	8013002	2030-01-08	U-2047		2017-02-10
N208780-001	8013002	2030-01-08	U-2082		2017-02-10
N208780-001	8084475	2030-01-08	U-2052		2017-02-10
N208780-001	8084475	2030-01-08	U-2054		2017-02-10
N208780-001	8318780	2030-01-08	U-2046		2017-02-10
N208780-001	8318780	2030-01-08	U-2081		2017-02-10
N208780-001	8648098	2030-01-08	U-2051		2017-02-10
N208780-001	8648098	2030-01-08	U-2052		2017-02-10
N208780-001	8754109	2030-01-08	U-2053		2017-02-10
N208780-001	8778947	2033-08-30	U-2044		2017-02-10
N208780-001	8778947	2033-08-30	U-2045		2017-02-10
N208780-001	10188637	2037-03-28		Drug product	2019-02-25
N208780-002	7767700	2027-12-18	U-2080		2018-03-08
N208780-002	8420674	2027-12-18	U-2079		2018-03-08
N208780-002	8383150	2028-05-10	U-2361	Drug product	2018-03-08
N208780-002	7566729	2029-04-22	U-2269		2018-03-08
N208780-002	7566729	2029-04-22	U-2270		2018-03-08
N208780-002	7635707	2029-04-22	U-2072		2018-03-08
N208780-002	7635707	2029-04-22	U-2073		2018-03-08
N208780-002	7635707	2029-04-22	U-2074		2018-03-08
N208780-002	7635707	2029-04-22	U-2075		2018-03-08
N208780-002	7635707	2029-04-22	U-2076		2018-03-08
N208780-002	7635707	2029-04-22	U-2083		2018-03-08
N208780-002	8592462	2029-04-22	U-2055		2018-03-08
N208780-002	8592462	2029-04-22	U-2056		2018-03-08
N208780-002	8592462	2029-04-22	U-2057		2018-03-08
N208780-002	8592462	2029-04-22	U-2058		2018-03-08
N208780-002	8592462	2029-04-22	U-2059		2018-03-08
N208780-002	8592462	2029-04-22	U-2060		2018-03-08
N208780-002	8592462	2029-04-22	U-2061		2018-03-08
N208780-002	8592462	2029-04-22	U-2062		2018-03-08
N208780-002	8592462	2029-04-22	U-2063		2018-03-08
N208780-002	8609701	2029-04-22	U-2064		2018-03-08
N208780-002	8609701	2029-04-22	U-2065		2018-03-08
N208780-002	8609701	2029-04-22	U-2066		2018-03-08
N208780-002	8609701	2029-04-22	U-2067		2018-03-08
N208780-002	8609701	2029-04-22	U-2068		2018-03-08
N208780-002	8609701	2029-04-22	U-2069		2018-03-08
N208780-002	8609701	2029-04-22	U-2070		2018-03-08
N208780-002	7816383	2030-01-08	U-2042		2018-03-08
N208780-002	7816383	2030-01-08	U-2050		2018-03-08
N208780-002	7910610	2030-01-08	U-2048		2018-03-08
N208780-002	7910610	2030-01-08	U-2049		2018-03-08
N208780-002	8013002	2030-01-08	U-2047		2018-03-08
N208780-002	8013002	2030-01-08	U-2082		2018-03-08
N208780-002	8084475	2030-01-08	U-2054		2018-03-08
N208780-002	8084475	2030-01-08	U-2268		2018-03-08
N208780-002	8318780	2030-01-08	U-2046		2018-03-08
N208780-002	8318780	2030-01-08	U-2081		2018-03-08

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208780-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208780-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208780-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208780-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208780-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208780-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208780-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208780-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208780-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208780-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208780-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208780-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208780-003	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208780-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208780-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208780-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208780-003	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 134 · 5,343 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208780-001	7767700	2027-12-18	U-2080		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8420674	2027-12-18	U-2079		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8383150	2028-05-10	U-2361	Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7566729	2029-04-22	U-2078		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7566729	2029-04-22	U-2077		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2083		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2074		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2072		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2075		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2076		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2073		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2060		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2063		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2056		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2058		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2057		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2059		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2061		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2055		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2062		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2065		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2069		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2066		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2067		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2068		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2070		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2064		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7816383	2030-01-08	U-2042		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7816383	2030-01-08	U-2050		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7910610	2030-01-08	U-2049		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7910610	2030-01-08	U-2048		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8013002	2030-01-08	U-2047		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8013002	2030-01-08	U-2082		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8084475	2030-01-08	U-2052		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8084475	2030-01-08	U-2054		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8318780	2030-01-08	U-2046		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8318780	2030-01-08	U-2081		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8648098	2030-01-08	U-2051		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8648098	2030-01-08	U-2052		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8754109	2030-01-08	U-2053		2017-02-10	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208780-001	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-001	ODE-77	2021-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-002	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-002	ODE-77	2021-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-003	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-003	ODE-77	2021-10-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208780-001	ODE-77	2021-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208780-002	ODE-77	2021-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208780-003	ODE-77	2021-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-001	ODE-77	2021-10-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-002	ODE-77	2021-10-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-003	ODE-77	2021-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208780-001	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208780-002	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208780-003	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208780-001	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208780-002	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208780-003	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208780-001	ODE-77	2021-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208780-002	ODE-77	2021-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208780-003	ODE-77	2021-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208780-001	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-001	ODE-77	2021-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-002	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-002	ODE-77	2021-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-003	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-003	ODE-77	2021-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208780-001	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-001	ODE-77	2021-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-002	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-002	ODE-77	2021-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-003	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-003	ODE-77	2021-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208780-001	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-001	ODE-77	2021-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-002	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-002	ODE-77	2021-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-003	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-003	ODE-77	2021-10-15	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESBRIET	PIRFENIDONE	Genentech, Inc.	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208780 application number: NDA208780 ndc (product): 50242-123 ndc (product): 50242-122
ESBRIET	PIRFENIDONE	Legacy Pharma USA Inc.	81f17f7d-cb04-4052-8682-dd3e330210ab	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208780 application number: NDA208780

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-122	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current
50242-123	ESBRIET	PIRFENIDONE	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73646	SUPPL	2023-03-01
73610	SUPPL	2023-02-27
70164	SUPPL	2022-02-15
70154	SUPPL	2022-02-14
59561	SUPPL	2019-08-02
59538	SUPPL	2019-08-01
52676	ORIG	2018-02-21
46876	ORIG	2017-01-18
46800	ORIG	2017-01-11