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Orange Book product · Brand (NDA)

VYBRIQUE

SILDENAFIL CITRATE

Brand (NDA)NDA 210858RX IBSA
View SILDENAFIL CITRATE familyOpen on FDA Orange Book

At a glance

Dec 16, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 16, 2025

    6 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Dec 16, 2028

    in 2 yr 6 mo

  4. Patent 11123287 expires

    Listed drug product patent expiration.

    Dec 16, 2033

    in 7 yr 7 mo

Pharmaceutical detail

Active ingredient

SILDENAFIL CITRATE

Strength

EQ 100MG BASE

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 210858

Product number

004

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Dec 16, 2028

    in 2 yr 6 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11123287Dec 16, 2033in 7 yr 7 mo
Product
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