Application 208254

Type: NDA
Sponsor: AERIE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RHOPRESSA	NETARSUDIL MESYLATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.02% BASE	Yes	Yes

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
N208254-001	RHOPRESSA	NETARSUDIL MESYLATE	EQ 0.02% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2017-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208254-001	10532993	2026-07-11	U-1524		2020-03-30
N208254-001	10882840	2026-07-11	U-1524		2021-01-22
N208254-001	11021456	2026-07-11	U-1524		2021-06-28
N208254-001	8450344	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21
N208254-001	9096569	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21
N208254-001	10174017	2030-01-27	U-1524	Drug substance, Drug product	2019-03-28
N208254-001	10654844	2030-01-27	U-1524	Drug substance, Drug product	2020-06-10
N208254-001	11028081	2030-01-27	U-1524		2021-06-28
N208254-001	11618748	2030-01-27	U-1524		2023-04-21
N208254-001	8394826	2030-11-10	U-1524	Drug substance, Drug product	2017-12-21
N208254-001	10588901	2034-03-14	U-1524	Drug substance, Drug product	2020-04-15
N208254-001	11020385	2034-03-14	U-1524		2024-07-12
N208254-001	11185538	2034-03-14		Drug product	2021-12-16
N208254-001	9415043	2034-03-14		Drug substance	2017-12-21
N208254-001	9931336	2034-03-14	U-1524	Drug substance, Drug product	2018-04-11

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	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208254-001	RHOPRESSA	EQ 0.02% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208254-001	RHOPRESSA	EQ 0.02% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208254-001	RHOPRESSA	EQ 0.02% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208254-001	RHOPRESSA	EQ 0.02% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-12-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 569 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	N208254-001	10532993	2026-07-11	U-1524		2020-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	10882840	2026-07-11	U-1524		2021-01-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	11021456	2026-07-11	U-1524		2021-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	8450344	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	9096569	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	10174017	2030-01-27	U-1524	Drug substance, Drug product	2019-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	10654844	2030-01-27	U-1524	Drug substance, Drug product	2020-06-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	11028081	2030-01-27	U-1524		2021-06-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	11618748	2030-01-27	U-1524		2023-04-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	8394826	2030-11-10	U-1524	Drug substance, Drug product	2017-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	10588901	2034-03-14	U-1524	Drug substance, Drug product	2020-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	11020385	2034-03-14	U-1524		2024-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	11185538	2034-03-14		Drug product	2021-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	9415043	2034-03-14		Drug substance	2017-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208254-001	9931336	2034-03-14	U-1524	Drug substance, Drug product	2018-04-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208254-001	10532993	2026-07-11	U-1524		2020-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	10882840	2026-07-11	U-1524		2021-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	11021456	2026-07-11	U-1524		2021-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	8450344	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	9096569	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	10174017	2030-01-27	U-1524	Drug substance, Drug product	2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	10654844	2030-01-27	U-1524	Drug substance, Drug product	2020-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	11028081	2030-01-27	U-1524		2021-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	11618748	2030-01-27	U-1524		2023-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	8394826	2030-11-10	U-1524	Drug substance, Drug product	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	10588901	2034-03-14	U-1524	Drug substance, Drug product	2020-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	11020385	2034-03-14	U-1524		2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	11185538	2034-03-14		Drug product	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	9415043	2034-03-14		Drug substance	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208254-001	9931336	2034-03-14	U-1524	Drug substance, Drug product	2018-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208254-001	10532993	2026-07-11	U-1524		2020-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	10882840	2026-07-11	U-1524		2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	11021456	2026-07-11	U-1524		2021-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	8450344	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	9096569	2026-07-11	U-1524	Drug substance, Drug product	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	10174017	2030-01-27	U-1524	Drug substance, Drug product	2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	10654844	2030-01-27	U-1524	Drug substance, Drug product	2020-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	11028081	2030-01-27	U-1524		2021-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	11618748	2030-01-27	U-1524		2023-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208254-001	8394826	2030-11-10	U-1524	Drug substance, Drug product	2017-12-21	`caaa826d4ba7…`

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	N208254-001	NCE	2022-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208254-001	NCE	2022-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208254-001	NCE	2022-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208254-001	NCE	2022-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208254-001	NCE	2022-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208254-001	NCE	2022-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208254-001	NCE	2022-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208254-001	NCE	2022-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208254-001	NCE	2022-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208254-001	NCE	2022-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208254-001	NCE	2022-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208254-001	NCE	2022-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208254-001	NCE	2022-12-18	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208254-001	NCE	2022-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208254-001	NCE	2022-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208254-001	NCE	2022-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208254-001	NCE	2022-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208254-001	NCE	2022-12-18	`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
Rhopressa	NETARSUDIL	Alcon Laboratories, Inc.	7d4f0e3a-5b86-4c43-982a-813b22ae7e22	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208254 application number: NDA208254 ndc (product): 70727-497

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
70727-497	Rhopressa	netarsudil	Aerie Pharmaceuticals, Inc.	NDA	Current
70727-497	Rhopressa	netarsudil	Aerie Pharmaceuticals, Inc.	NDA	Current
70727-497	Rhopressa	netarsudil	Aerie Pharmaceuticals Inc.	NDA	Current
70727-497	Rhopressa	netarsudil	Aerie Pharmaceuticals, Inc.	NDA	Current
70727-497	Rhopressa	netarsudil	Aerie Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79663	SUPPL	2024-09-20
79660	SUPPL	2024-09-19
58099	SUPPL	2019-03-27
52052	ORIG	2018-01-29
50758	ORIG	2017-12-18
50757	ORIG	2017-12-18