Assyro AI

Orange Book product · Brand (NDA)

FARYDAK

PANOBINOSTAT LACTATE

Brand (NDA)NDA 205353DISCN SECURA

At a glance

Feb 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 23, 2015

    11 yr 6 mo ago

  2. Today

  3. Patent 7989494 expires

    Listed drug substance patent expiration.

    Jan 17, 2028

    in 1 yr 7 mo

  4. Patent 8883842 expires

    Listed method-of-use patent (U-1669) expiration.

    Jun 13, 2028

    in 2 yr

Pharmaceutical detail

Active ingredient

PANOBINOSTAT LACTATE

Strength

EQ 15MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205353

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.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7989494Jan 17, 2028in 1 yr 7 mo
SubstanceProduct
8883842Jun 13, 2028in 2 yr
U-1669
Agent CTA Background

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