Application 213978

Type: NDA
Sponsor: OYSTER POINT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TYRVAYA	VARENICLINE TARTRATE	SOLUTION;NASAL	EQ 0.03MG BASE/SPRAY	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
N213978-001	TYRVAYA	VARENICLINE TARTRATE	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL		RLD, RS	2021-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04
N213978-001	11224598	2035-10-19	U-1900		2022-01-28
N213978-001	11903941	2035-10-19	U-1900		2024-03-08
N213978-001	11903942	2035-10-19		Drug product	2024-03-08
N213978-001	11903943	2035-10-19	U-1900		2024-03-08
N213978-001	11911380	2035-10-19	U-1900		2024-03-08
N213978-001	12576080	2035-10-19	U-1900		2026-04-10
N213978-001	12653824	2035-10-19		Drug product	2026-07-07
N213978-001	9504644	2035-10-19	U-1900		2021-11-04
N213978-001	9504645	2035-10-19		Drug product	2021-11-04
N213978-001	9532944	2035-10-19	U-1900		2021-11-04
N213978-001	9597284	2035-10-19	U-1900		2021-11-04

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
2026-10-15 13:18:30	2026-09	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SOLUTION / NASAL	RLD, RS	2021-10-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213978-001	TYRVAYA	EQ 0.03MG BASE/SPRAY	SPRAY / NASAL	RLD, RS	2021-10-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 295 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	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11903943	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	11911380	2035-10-19	U-1900		2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	12576080	2035-10-19	U-1900		2026-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	12653824	2035-10-19		Drug product	2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9504644	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9504645	2035-10-19		Drug product	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9532944	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213978-001	9597284	2035-10-19	U-1900		2021-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213978-001	10456396	2035-10-19	U-1900	Drug product	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213978-001	11224598	2035-10-19	U-1900		2022-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213978-001	11903941	2035-10-19	U-1900		2024-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213978-001	11903942	2035-10-19		Drug product	2024-03-08	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213978-001	NP	2024-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213978-001	NP	2024-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213978-001	NP	2024-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213978-001	NP	2024-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213978-001	NP	2024-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213978-001	NP	2024-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213978-001	NP	2024-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213978-001	NP	2024-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213978-001	NP	2024-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213978-001	NP	2024-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213978-001	NP	2024-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213978-001	NP	2024-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213978-001	NP	2024-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213978-001	NP	2024-10-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213978-001	NP	2024-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213978-001	NP	2024-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213978-001	NP	2024-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213978-001	NP	2024-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213978-001	NP	2024-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213978-001	NP	2024-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213978-001	NP	2024-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213978-001	NP	2024-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213978-001	NP	2024-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213978-001	NP	2024-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213978-001	NP	2024-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213978-001	NP	2024-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213978-001	NP	2024-10-15	`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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
varenicline	VARENICLINE TARTRATE	A-S Medication Solutions	2d5dfa6e-e69d-414a-8ff2-44714debbbe2	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
varenicline	VARENICLINE TARTRATE	Major Pharmaceuticals	1297c291-da28-4a73-9c28-d5adee36d7b7	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
Varenicline	VARENICLINE TARTRATE	Camber Pharmaceuticals, Inc.	7bd1abc8-2689-496b-b3f2-1cefe218ff5a	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	0fefd790-b526-4f2f-8c83-5f39f7306556	2020-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	f22e3aef-714b-4014-8d77-83ee03fd1f57	2020-01-01	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE
CHANTIX	VARENICLINE TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b4403cea-6300-4d89-8fde-5149a80b08b9	2017-12-18	Warnings, Adverse reactions	Name fallback generic name: VARENICLINE TARTRATE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73521-030	Tyrvaya	varenicline	Oyster Point Pharma	NDA	Current
73521-030	Tyrvaya	varenicline	Oyster Point Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77401	SUPPL	2024-02-06
77398	SUPPL	2024-02-05
71206	ORIG	2022-06-03
69035	ORIG	2021-10-20
69029	ORIG	2021-10-19