Assyro AI

Orange Book product · Brand (NDA)

EMBLAVEO

AVIBACTAM SODIUM; AZTREONAM

Brand (NDA)NDA 217906RX ABBVIE

At a glance

Feb 07, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 07, 2025

    1 yr 5 mo ago

  2. Patent 7112592 expires

    Listed drug substance patent expiration.

    Jan 07, 2026

    5 mo ago

  3. Today

  4. Patent 7612087 expires

    Listed drug product patent expiration.

    Nov 12, 2026

    in 5 mo

  5. Exclusivity ends · NP

    New product exclusivity (3 years)

    Feb 07, 2028

    in 1 yr 8 mo

  6. Patent 8835455 expires

    Listed drug product patent expiration.

    Oct 08, 2030

    in 4 yr 4 mo

  7. Patent 8471025 expires

    Listed drug substance patent expiration.

    Aug 12, 2031

    in 5 yr 3 mo

  8. Patent 8969566 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

  9. Patent 9284314 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

  10. Patent 9695122 expires

    Listed drug substance patent expiration.

    Jun 15, 2032

    in 6 yr 1 mo

  11. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Feb 07, 2033

    in 6 yr 9 mo

Pharmaceutical detail

Active ingredient

AVIBACTAM SODIUM; AZTREONAM

Strength

EQ 0.5GM BASE/VIAL;1.5GM/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 217906

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)

    Feb 07, 2028

    in 1 yr 8 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Feb 07, 2033

    in 6 yr 9 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7112592Jan 07, 20265 mo ago
SubstanceProductU-4147
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
SubstanceProduct
Agent CTA Background

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