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 1.

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N218490-001	OPSYNVI	10MG;20MG	TABLET / ORAL		RLD	2024-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	OPSYNVI	10MG;40MG	TABLET / ORAL		RLD, RS	2024-03-22	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N218490-001	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	7094781*PED	2026-06-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	10946015*PED	2027-03-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	8268847*PED	2029-10-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	7094781	2025-12-05		Drug substance, Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	7094781*PED	2026-06-05		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	10946015	2026-09-11	U-3881	Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	10946015*PED	2027-03-11		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	8268847	2029-04-18	U-3882	Drug product	2024-04-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	8268847*PED	2029-10-18		Pediatric extension		`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N218490-001	NP	2027-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	PED	2027-09-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	ODE-475	2031-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-001	PED	2031-09-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	NP	2027-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	PED	2027-09-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	ODE-475	2031-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N218490-002	PED	2031-09-22	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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