Application 211911

Type: NDA
Sponsor: ALLERGAN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURYSTA	BIMATOPROST	IMPLANT;OPHTHALMIC	10MCG	Yes	Yes

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

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
N211911-001	DURYSTA	BIMATOPROST	10MCG	IMPLANT / OPHTHALMIC		RLD, RS	2020-03-04

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211911-001	10441543	2026-12-19		Drug product	2020-03-24
N211911-001	9149428	2026-12-19		Drug product	2020-03-24
N211911-001	8206737	2027-04-07	U-2759		2020-03-24
N211911-001	7799336	2029-04-24		Drug product	2020-03-24
N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24
N211911-001	9492316	2034-10-31		Drug product	2020-03-24
N211911-001	9980974	2034-10-31	U-2759		2020-03-24

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211911-001	DURYSTA	10MCG	IMPLANT / OPHTHALMIC	RLD, RS	2020-03-04	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 327 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	N211911-001	10441543	2026-12-19		Drug product	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	9149428	2026-12-19		Drug product	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	8206737	2027-04-07	U-2759		2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	7799336	2029-04-24		Drug product	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	9492316	2034-10-31		Drug product	2020-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211911-001	9980974	2034-10-31	U-2759		2020-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	8673341	2025-02-19	U-2759		2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	10441543	2026-12-19		Drug product	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	9149428	2026-12-19		Drug product	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	8206737	2027-04-07	U-2759		2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	7799336	2029-04-24		Drug product	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	9492316	2034-10-31		Drug product	2020-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211911-001	9980974	2034-10-31	U-2759		2020-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211911-001	8673341	2025-02-19	U-2759		2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	10441543	2026-12-19		Drug product	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	9149428	2026-12-19		Drug product	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	8206737	2027-04-07	U-2759		2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	7799336	2029-04-24		Drug product	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	9492316	2034-10-31		Drug product	2020-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211911-001	9980974	2034-10-31	U-2759		2020-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	8673341	2025-02-19	U-2759		2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	10441543	2026-12-19		Drug product	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	9149428	2026-12-19		Drug product	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	8206737	2027-04-07	U-2759		2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	7799336	2029-04-24		Drug product	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	9492316	2034-10-31		Drug product	2020-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211911-001	9980974	2034-10-31	U-2759		2020-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	8673341	2025-02-19	U-2759		2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	10441543	2026-12-19		Drug product	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	9149428	2026-12-19		Drug product	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	8206737	2027-04-07	U-2759		2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	7799336	2029-04-24		Drug product	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	8629185	2031-07-15		Drug substance, Drug product	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	9492316	2034-10-31		Drug product	2020-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211911-001	9980974	2034-10-31	U-2759		2020-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211911-001	10398707	2024-04-30	U-2759		2020-03-24	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211911-001	NP	2023-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211911-001	NP	2023-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211911-001	NP	2023-03-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211911-001	NP	2023-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211911-001	NP	2023-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211911-001	NP	2023-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211911-001	NP	2023-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211911-001	NP	2023-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211911-001	NP	2023-03-04	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N211911-001	NP	2023-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211911-001	NP	2023-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211911-001	NP	2023-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211911-001	NP	2023-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211911-001	NP	2023-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211911-001	NP	2023-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211911-001	NP	2023-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211911-001	NP	2023-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211911-001	NP	2023-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211911-001	NP	2023-03-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211911-001	NP	2023-03-04	`cb3db0bc1861…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DURYSTA	BIMATOPROST	Allergan, Inc.	3f59da84-0bcc-4c84-b3e2-e215681ef341	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211911 application number: NDA211911 ndc (product): 0023-9652

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current
0023-9652	DURYSTA	bimatoprost	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79868	SUPPL	2024-10-11
79860	SUPPL	2024-10-11
65152	SUPPL	2020-11-04
65148	SUPPL	2020-11-04
64438	ORIG	2020-08-27
62042	ORIG	2020-03-05
62038	ORIG	2020-03-05