Application 218490

Type: NDA
Sponsor: ACTELION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPSYNVI	MACITENTAN; TADALAFIL	TABLET;ORAL	10MG;20MG	Yes	No
002	OPSYNVI	MACITENTAN; TADALAFIL	TABLET;ORAL	10MG;40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218490-001	OPSYNVI	MACITENTAN; TADALAFIL	10MG;20MG	TABLET / ORAL		RLD	2024-03-22
N218490-002	OPSYNVI	MACITENTAN; TADALAFIL	10MG;40MG	TABLET / ORAL		RLD, RS	2024-03-22

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
N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18
N218490-001	7094781*PED	2026-06-05		Pediatric extension
N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18
N218490-001	10946015*PED	2027-03-11		Pediatric extension
N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18
N218490-001	8268847*PED	2029-10-18		Pediatric extension
N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18
N218490-002	7094781*PED	2026-06-05		Pediatric extension
N218490-002	10946015	2026-09-11	U-3881	Drug product	2024-04-18
N218490-002	10946015*PED	2027-03-11		Pediatric extension
N218490-002	8268847	2029-04-18	U-3882	Drug product	2024-04-18
N218490-002	8268847*PED	2029-10-18		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218490-001	NP	2027-03-22
N218490-001	PED	2027-09-22
N218490-001	ODE-475	2031-03-22
N218490-001	PED	2031-09-22
N218490-002	NP	2027-03-22
N218490-002	PED	2027-09-22
N218490-002	ODE-475	2031-03-22
N218490-002	PED	2031-09-22

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
2026-08-18 06:07:40	2026-07	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL	RLD	2024-03-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL	RLD, RS	2024-03-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	7094781*PED	2026-06-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	10946015*PED	2027-03-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	8268847*PED	2029-10-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	7094781*PED	2026-06-05		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	10946015*PED	2027-03-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	8268847*PED	2029-10-18		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	7094781*PED	2026-06-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	10946015*PED	2027-03-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	8268847*PED	2029-10-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	7094781*PED	2026-06-05		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	10946015*PED	2027-03-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	8268847*PED	2029-10-18		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	7094781*PED	2026-06-05		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	10946015*PED	2027-03-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	8268847*PED	2029-10-18		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	7094781*PED	2026-06-05		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	10946015*PED	2027-03-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	8268847*PED	2029-10-18		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N218490-001	NP	2027-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	PED	2027-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	ODE-475	2031-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-001	PED	2031-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	NP	2027-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	PED	2027-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	ODE-475	2031-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218490-002	PED	2031-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218490-001	NP	2027-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	PED	2027-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	ODE-475	2031-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-001	PED	2031-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	NP	2027-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	PED	2027-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	ODE-475	2031-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218490-002	PED	2031-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	NP	2027-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	PED	2027-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	ODE-475	2031-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-001	PED	2031-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	NP	2027-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	PED	2027-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	ODE-475	2031-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218490-002	PED	2031-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218490-001	NP	2027-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-001	ODE-475	2031-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-002	NP	2027-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218490-002	ODE-475	2031-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-001	NP	2027-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-001	ODE-475	2031-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-002	NP	2027-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218490-002	ODE-475	2031-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-001	NP	2027-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-001	ODE-475	2031-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-002	NP	2027-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218490-002	ODE-475	2031-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-001	NP	2027-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-001	ODE-475	2031-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-002	NP	2027-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218490-002	ODE-475	2031-03-22	`03ed91905a0d…`

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
OPSYNVI	MACITENTAN AND TADALAFIL	Actelion Pharmaceuticals US, Inc.	6945b183-18d3-40de-afd1-c88e33cc1a63	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218490 application number: NDA218490

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81891	SUPPL	2025-04-08
81822	SUPPL	2025-04-03
80567	SUPPL	2024-12-13
79983	ORIG	2024-10-25
77958	ORIG	2024-03-25
77957	ORIG	2024-03-25
77953	ORIG	2024-03-25