Assyro AI

Orange Book product · Brand (NDA)

FERRIPROX

DEFERIPRONE

Brand (NDA)NDA 208030DISCN CHIESI

At a glance

Apr 20, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 20, 2018

    8 yr 3 mo ago

  2. Today

  3. Exclusivity ends · ODE-417

    Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

  4. Exclusivity ends · ODE-418

    Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

  5. Exclusivity ends · ODE-419

    Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

  6. Patent 8703156 expires

    Listed drug product patent expiration.

    Oct 26, 2029

    in 3 yr 5 mo

Pharmaceutical detail

Active ingredient

DEFERIPRONE

Strength

80MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 208030

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (3)

  • ODE-417Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

  • ODE-418Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

  • ODE-419Orphan-drug exclusivity (7 years)

    Apr 30, 2028

    in 1 yr 11 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8703156Oct 26, 2029in 3 yr 5 mo
ProductU-3083
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.