Assyro AI

Orange Book product · Brand (NDA)

TALICIA

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Brand (NDA)NDA 213004RX TALICIA HOLDINGS

At a glance

Nov 01, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 01, 2019

    6 yr 9 mo ago

  2. Exclusivity ends · NP

    New product exclusivity (3 years)

    Nov 01, 2022

    3 yr 8 mo ago

  3. Today

  4. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Nov 01, 2027

    in 1 yr 5 mo

  5. Patent 10238606 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  6. Patent 11135172 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  7. Patent 11931463 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  8. Patent 9050263 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  9. Patent 9498445 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  10. Patent 9603806 expires

    Listed drug product patent expiration.

    Feb 12, 2034

    in 7 yr 9 mo

  11. Patent 11878011 expires

    Listed method-of-use patent (U-3816) expiration.

    May 27, 2042

    in 16 yr 2 mo

Pharmaceutical detail

Active ingredient

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Strength

250MG;EQ 10MG BASE;12.5MG

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 213004

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.

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Nov 01, 2022

    3 yr 8 mo ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Nov 01, 2027

    in 1 yr 5 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10238606Feb 12, 2034in 7 yr 9 mo
Product
11135172Feb 12, 2034in 7 yr 9 mo
ProductU-2660
11931463Feb 12, 2034in 7 yr 9 mo
ProductU-3866
9050263Feb 12, 2034in 7 yr 9 mo
ProductU-2660
9498445Feb 12, 2034in 7 yr 9 mo
ProductU-2660
9603806Feb 12, 2034in 7 yr 9 mo
ProductU-2660
11878011May 27, 2042in 16 yr 2 mo
U-3816
Agent CTA Background

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