Assyro AI

Orange Book product · Brand (NDA)

AVYCAZ

AVIBACTAM SODIUM; CEFTAZIDIME

Brand (NDA)NDA 206494RX ABBVIE

At a glance

Feb 25, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 25, 2015

    11 yr 6 mo ago

  2. Patent 7112592 expires

    Listed drug substance patent expiration.

    Jan 07, 2026

    5 mo ago

  3. Patent 7112592 expires

    Listed drug substance patent expiration.

    Jan 07, 2026

    5 mo ago

  4. Patent 7112592 expires

    Listed drug substance patent expiration.

    Jan 07, 2026

    5 mo ago

  5. Patent 7112592 expires

    Listed drug substance patent expiration.

    Jan 07, 2026

    5 mo ago

  6. Today

  7. Patent 7612087 expires

    Listed drug product patent expiration.

    Nov 12, 2026

    in 5 mo

  8. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Jan 26, 2027

    in 7 mo

  9. Patent 8835455 expires

    Listed drug product patent expiration.

    Oct 08, 2030

    in 4 yr 4 mo

  10. Patent 8471025 expires

    Listed drug substance patent expiration.

    Aug 12, 2031

    in 5 yr 3 mo

  11. Patent 8969566 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

  12. Patent 9284314 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

  13. Patent 9695122 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

Pharmaceutical detail

Active ingredient

AVIBACTAM SODIUM; CEFTAZIDIME

Strength

EQ 0.5GM BASE;2GM/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 206494

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 (1)

  • NPPNew patient population exclusivity (3 years)

    Jan 26, 2027

    in 7 mo

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7112592Jan 07, 20265 mo ago
SubstanceProductU-2508
7112592Jan 07, 20265 mo ago
SubstanceProductU-2244
7112592Jan 07, 20265 mo ago
SubstanceProductU-282
7112592Jan 07, 20265 mo ago
SubstanceProductU-3818
7612087Nov 12, 2026in 5 mo
Product
8835455Oct 08, 2030in 4 yr 4 mo
Product
8471025Aug 12, 2031in 5 yr 3 mo
Substance
8969566Jun 15, 2032in 6 yr 1 mo
Substance
9284314Jun 15, 2032in 6 yr 1 mo
Substance
9695122Jun 15, 2032in 6 yr 1 mo
Substance
Agent CTA Background

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