Assyro AI

Orange Book product · Brand (NDA)

STRIBILD

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Brand (NDA)NDA 203100RX GILEAD SCIENCES INC

At a glance

Aug 27, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

14

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 27, 2012

    14 yr ago

  2. Today

  3. Patent 7176220 expires

    Listed drug substance patent expiration.

    Aug 27, 2026

    in 2 mo

  4. Patent 7635704 expires

    Listed drug substance patent expiration.

    Oct 26, 2026

    in 4 mo

  5. Patent 8981103 expires

    Listed drug substance patent expiration.

    Oct 26, 2026

    in 4 mo

  6. Patent 7176220*PED expires

    Listed listed patent expiration.

    Feb 27, 2027

    in 8 mo

  7. Patent 7635704*PED expires

    Listed listed patent expiration.

    Apr 26, 2027

    in 10 mo

  8. Patent 8981103*PED expires

    Listed listed patent expiration.

    Apr 26, 2027

    in 10 mo

  9. Patent 8148374 expires

    Listed drug substance patent expiration.

    Sep 03, 2029

    in 3 yr 3 mo

  10. Patent 9891239 expires

    Listed drug product patent expiration.

    Sep 03, 2029

    in 3 yr 3 mo

  11. Patent 8148374*PED expires

    Listed listed patent expiration.

    Mar 03, 2030

    in 3 yr 9 mo

  12. Patent 9891239*PED expires

    Listed listed patent expiration.

    Mar 03, 2030

    in 3 yr 9 mo

  13. Patent 8633219 expires

    Listed drug product patent expiration.

    Apr 30, 2030

    in 3 yr 11 mo

  14. Patent 8633219*PED expires

    Listed listed patent expiration.

    Oct 30, 2030

    in 4 yr 5 mo

  15. Patent 10039718 expires

    Listed drug product patent expiration.

    Oct 06, 2032

    in 6 yr 5 mo

  16. Patent 10039718*PED expires

    Listed listed patent expiration.

    Apr 06, 2033

    in 6 yr 11 mo

Pharmaceutical detail

Active ingredient

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Strength

150MG;150MG;200MG;300MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 203100

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.

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7176220Aug 27, 2026in 2 mo
SubstanceProductU-257
7635704Oct 26, 2026in 4 mo
SubstanceProductU-257
8981103Oct 26, 2026in 4 mo
SubstanceProduct
7176220*PEDFeb 27, 2027in 8 mo
7635704*PEDApr 26, 2027in 10 mo
8981103*PEDApr 26, 2027in 10 mo
8148374Sep 03, 2029in 3 yr 3 mo
SubstanceProductU-1279
9891239Sep 03, 2029in 3 yr 3 mo
ProductU-257
8148374*PEDMar 03, 2030in 3 yr 9 mo
9891239*PEDMar 03, 2030in 3 yr 9 mo
8633219Apr 30, 2030in 3 yr 11 mo
ProductU-257
8633219*PEDOct 30, 2030in 4 yr 5 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.