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Orange Book product · Brand (NDA)

VYKOURA

LEUCOVORIN CALCIUM

Brand (NDA)NDA 220406RX AVYXA HOLDINGS
View LEUCOVORIN CALCIUM familyOpen on FDA Orange Book

At a glance

Feb 03, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 03, 2026

    5 mo ago

  2. Today

  3. Patent 12564592 expires

    Listed drug product patent expiration.

    Dec 23, 2044

    in 18 yr 9 mo

Pharmaceutical detail

Active ingredient

LEUCOVORIN CALCIUM

Strength

EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS

TE code

Not listed

Application

NDA 220406

Product number

001

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.

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12564592Dec 23, 2044in 18 yr 9 mo
Product
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