Assyro AI

Orange Book product · Brand (NDA)

JASCAYD

NERANDOMILAST

Brand (NDA)NDA 218764RX BOEHRINGER INGELHEIM

At a glance

Oct 07, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 07, 2025

    9 mo ago

  2. Today

  3. Exclusivity ends · I-979

    New indication exclusivity (3 years)

    Dec 19, 2028

    in 2 yr 6 mo

  4. Patent 8754073 expires

    Listed drug substance patent expiration.

    Nov 26, 2029

    in 3 yr 6 mo

  5. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Oct 07, 2030

    in 4 yr 4 mo

  6. Patent 8609670 expires

    Listed drug substance patent expiration.

    Aug 23, 2032

    in 6 yr 3 mo

  7. Exclusivity ends · ODE-546

    Orphan-drug exclusivity (7 years)

    Oct 07, 2032

    in 6 yr 5 mo

  8. Patent 9802954 expires

    Listed method-of-use patent (U-4298) expiration.

    Feb 19, 2034

    in 7 yr 9 mo

  9. Patent 11406638 expires

    Listed method-of-use patent (U-4373) expiration.

    Oct 22, 2038

    in 12 yr 6 mo

  10. Patent 11406638 expires

    Listed method-of-use patent (U-4297) expiration.

    Oct 22, 2038

    in 12 yr 6 mo

  11. Patent 11813266 expires

    Listed method-of-use patent (U-4372) expiration.

    Oct 22, 2038

    in 12 yr 6 mo

  12. Patent 11813266 expires

    Listed method-of-use patent (U-4292) expiration.

    Oct 22, 2038

    in 12 yr 6 mo

Pharmaceutical detail

Active ingredient

NERANDOMILAST

Strength

9MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 218764

Product number

001

Marketing status

RX

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)

  • I-979New indication exclusivity (3 years)

    Dec 19, 2028

    in 2 yr 6 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 07, 2030

    in 4 yr 4 mo

  • ODE-546Orphan-drug exclusivity (7 years)

    Oct 07, 2032

    in 6 yr 5 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8754073Nov 26, 2029in 3 yr 6 mo
SubstanceProductU-4298
8609670Aug 23, 2032in 6 yr 3 mo
Substance
9802954Feb 19, 2034in 7 yr 9 mo
U-4298
11406638Oct 22, 2038in 12 yr 6 mo
U-4373
11406638Oct 22, 2038in 12 yr 6 mo
U-4297
11813266Oct 22, 2038in 12 yr 6 mo
U-4372
11813266Oct 22, 2038in 12 yr 6 mo
U-4292
Agent CTA Background

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