Assyro AI

Orange Book product · Brand (NDA)

TYBOST

COBICISTAT

Brand (NDA)NDA 203094DISCN GILEAD SCIENCES INC

At a glance

Jun 20, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

4

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 20, 2025

    1 yr ago

  2. Today

  3. Patent 8148374 expires

    Listed drug substance patent expiration.

    Sep 03, 2029

    in 3 yr 3 mo

  4. Patent 8148374*PED expires

    Listed listed patent expiration.

    Mar 03, 2030

    in 3 yr 9 mo

  5. Patent 10039718 expires

    Listed drug product patent expiration.

    Oct 06, 2032

    in 6 yr 5 mo

  6. Patent 10039718*PED expires

    Listed listed patent expiration.

    Apr 06, 2033

    in 6 yr 11 mo

Pharmaceutical detail

Active ingredient

COBICISTAT

Strength

90MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 203094

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 (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8148374Sep 03, 2029in 3 yr 3 mo
SubstanceProductU-1279
8148374*PEDMar 03, 2030in 3 yr 9 mo
10039718Oct 06, 2032in 6 yr 5 mo
Product
10039718*PEDApr 06, 2033in 6 yr 11 mo
Agent CTA Background

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