Assyro AI

Orange Book product · Brand (NDA)

MODEYSO

DORDAVIPRONE HYDROCHLORIDE

Brand (NDA)NDA 219876RX CHIMERIX

At a glance

Aug 06, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 06, 2025

    11 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Aug 06, 2030

    in 4 yr 2 mo

  4. Patent 9629842 expires

    Listed method-of-use patent (U-4254) expiration.

    Apr 30, 2032

    in 5 yr 11 mo

  5. Patent RE46290 expires

    Listed method-of-use patent (U-4254) expiration.

    Apr 30, 2032

    in 5 yr 11 mo

  6. Exclusivity ends · ODE-547

    Orphan-drug exclusivity (7 years)

    Aug 06, 2032

    in 6 yr 3 mo

  7. Patent 9265765 expires

    Listed drug product patent expiration.

    Jul 26, 2034

    in 8 yr 3 mo

  8. Patent 11976068 expires

    Listed drug product patent expiration.

    Mar 01, 2036

    in 9 yr 10 mo

  9. Patent 10172862 expires

    Listed method-of-use patent (U-4254) expiration.

    Jan 30, 2037

    in 10 yr 9 mo

  10. Patent 10369154 expires

    Listed method-of-use patent (U-4254) expiration.

    Jan 30, 2037

    in 10 yr 9 mo

  11. Patent 12102639 expires

    Listed method-of-use patent (U-4254) expiration.

    Jan 30, 2037

    in 10 yr 9 mo

Pharmaceutical detail

Active ingredient

DORDAVIPRONE HYDROCHLORIDE

Strength

EQ 125MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 219876

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.

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Aug 06, 2030

    in 4 yr 2 mo

  • ODE-547Orphan-drug exclusivity (7 years)

    Aug 06, 2032

    in 6 yr 3 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9629842Apr 30, 2032in 5 yr 11 mo
U-4254
RE46290Apr 30, 2032in 5 yr 11 mo
U-4254
9265765Jul 26, 2034in 8 yr 3 mo
Product
11976068Mar 01, 2036in 9 yr 10 mo
Product
10172862Jan 30, 2037in 10 yr 9 mo
U-4254
10369154Jan 30, 2037in 10 yr 9 mo
U-4254
12102639Jan 30, 2037in 10 yr 9 mo
U-4254
Agent CTA Background

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