Application 210858

Type: NDA
Sponsor: IBSA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYBRIQUE	SILDENAFIL CITRATE	FILM;ORAL	EQ 25MG BASE	Yes	No
002	VYBRIQUE	SILDENAFIL CITRATE	FILM;ORAL	EQ 50MG BASE	Yes	No
003	VYBRIQUE	SILDENAFIL CITRATE	FILM;ORAL	EQ 75MG BASE	Yes	No
004	VYBRIQUE	SILDENAFIL CITRATE	FILM;ORAL	EQ 100MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210858-001	VYBRIQUE	SILDENAFIL CITRATE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-002	VYBRIQUE	SILDENAFIL CITRATE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-003	VYBRIQUE	SILDENAFIL CITRATE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-004	VYBRIQUE	SILDENAFIL CITRATE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210858-001	11123287	2033-12-16	Drug product	2026-01-09
N210858-002	11123287	2033-12-16	Drug product	2026-01-09
N210858-003	11123287	2033-12-16	Drug product	2026-01-09
N210858-004	11123287	2033-12-16	Drug product	2026-01-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210858-001	NP	2028-12-16
N210858-002	NP	2028-12-16
N210858-003	NP	2028-12-16
N210858-004	NP	2028-12-16

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	N210858-001	VYBRIQUE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	VYBRIQUE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	VYBRIQUE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	VYBRIQUE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	VYBRIQUE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	VYBRIQUE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	VYBRIQUE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	VYBRIQUE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210858-001	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210858-001	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	NP	2028-12-16	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	NP	2028-12-16	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL CITRATE	Yaral Pharma Inc.	a17a970e-25a2-4807-9644-74e6d2bd2383	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210858 application number: NDA210858
Vybrique	SILDENAFIL CITRATE	IBSA Pharma Inc.	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210858 application number: NDA210858

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84726	ORIG	2026-01-09
84433	ORIG	2025-12-17