Assyro AI

Orange Book product · Brand (NDA)

CABTREO

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Brand (NDA)NDA 216632RX BAUSCH

At a glance

Oct 20, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 20, 2023

    2 yr 8 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Oct 20, 2026

    in 4 mo

  4. Patent 10220049 expires

    Listed drug product patent expiration.

    Jun 03, 2029

    in 3 yr

  5. Patent 10624918 expires

    Listed method-of-use patent (U-3713) expiration.

    Jun 03, 2029

    in 3 yr

  6. Patent 9561208 expires

    Listed drug product patent expiration.

    Jun 03, 2029

    in 3 yr

  7. Patent 8288434 expires

    Listed drug product patent expiration.

    Aug 05, 2029

    in 3 yr 2 mo

  8. Patent 12128059 expires

    Listed drug product patent expiration.

    Jul 31, 2040

    in 14 yr 4 mo

  9. Patent 12133859 expires

    Listed drug product patent expiration.

    Jul 31, 2040

    in 14 yr 4 mo

  10. Patent 12138278 expires

    Listed drug product patent expiration.

    Jul 31, 2040

    in 14 yr 4 mo

  11. Patent 12616710 expires

    Listed drug product patent expiration.

    Jul 31, 2040

    in 14 yr 4 mo

  12. Patent 11389467 expires

    Listed drug product patent expiration.

    Dec 28, 2040

    in 14 yr 9 mo

Pharmaceutical detail

Active ingredient

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Strength

0.15%;3.1%;1.2%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

NDA 216632

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)

  • NPNew product exclusivity (3 years)

    Oct 20, 2026

    in 4 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10220049Jun 03, 2029in 3 yr
ProductU-3713
10624918Jun 03, 2029in 3 yr
U-3713
9561208Jun 03, 2029in 3 yr
ProductU-3713
8288434Aug 05, 2029in 3 yr 2 mo
ProductU-3713
12128059Jul 31, 2040in 14 yr 4 mo
ProductU-3713
12133859Jul 31, 2040in 14 yr 4 mo
Product
12138278Jul 31, 2040in 14 yr 4 mo
Product
12616710Jul 31, 2040in 14 yr 4 mo
Product
11389467Dec 28, 2040in 14 yr 9 mo
ProductU-3713
Agent CTA Background

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