Assyro AI

Orange Book product · Brand (NDA)

ZYDELIG

IDELALISIB

Brand (NDA)NDA 205858TE ABRX GILEAD SCIENCES INC

At a glance

Jul 23, 2014

Approved

Brand (NDA)

Application

AB

TE code

4

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 23, 2014

    12 yr 1 mo ago

  2. Today

  3. Patent 9492449 expires

    Listed method-of-use patent (U-1914) expiration.

    Mar 11, 2030

    in 3 yr 9 mo

  4. Patent 10730879 expires

    Listed drug substance patent expiration.

    Mar 05, 2033

    in 6 yr 10 mo

  5. Patent 8865730 expires

    Listed drug substance patent expiration.

    Mar 05, 2033

    in 6 yr 10 mo

  6. Patent 9469643 expires

    Listed drug substance patent expiration.

    Sep 02, 2033

    in 7 yr 4 mo

Pharmaceutical detail

Active ingredient

IDELALISIB

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 205858

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.

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9492449Mar 11, 2030in 3 yr 9 mo
U-1914
10730879Mar 05, 2033in 6 yr 10 mo
SubstanceProduct
8865730Mar 05, 2033in 6 yr 10 mo
SubstanceProductU-1615
9469643Sep 02, 2033in 7 yr 4 mo
Substance
Agent CTA Background

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