Assyro AI

Orange Book product · Brand (NDA)

JYLAMVO

METHOTREXATE

Brand (NDA)NDA 212479RX SHORLA

At a glance

Nov 29, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 29, 2022

    3 yr 7 mo ago

  2. Today

  3. Patent 11771701 expires

    Listed drug product patent expiration.

    Oct 29, 2034

    in 8 yr 6 mo

  4. Patent 11771701 expires

    Listed drug product patent expiration.

    Oct 29, 2034

    in 8 yr 6 mo

  5. Patent 11771701 expires

    Listed drug product patent expiration.

    Oct 29, 2034

    in 8 yr 6 mo

  6. Patent 11771701 expires

    Listed drug product patent expiration.

    Oct 29, 2034

    in 8 yr 6 mo

  7. Patent 11771701 expires

    Listed drug product patent expiration.

    Oct 29, 2034

    in 8 yr 6 mo

  8. Patent 12605385 expires

    Listed drug product patent expiration.

    Oct 25, 2035

    in 9 yr 6 mo

  9. Patent 11129833 expires

    Listed drug product patent expiration.

    Oct 28, 2035

    in 9 yr 6 mo

Pharmaceutical detail

Active ingredient

METHOTREXATE

Strength

2MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 212479

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 (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11771701Oct 29, 2034in 8 yr 6 mo
ProductU-3700
11771701Oct 29, 2034in 8 yr 6 mo
ProductU-3701
11771701Oct 29, 2034in 8 yr 6 mo
ProductU-3702
11771701Oct 29, 2034in 8 yr 6 mo
ProductU-3703
11771701Oct 29, 2034in 8 yr 6 mo
ProductU-3704
12605385Oct 25, 2035in 9 yr 6 mo
Product
11129833Oct 28, 2035in 9 yr 6 mo
Product
Agent CTA Background

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