Assyro AI

Orange Book product · Brand (NDA)

TWYNEO

BENZOYL PEROXIDE; TRETINOIN

Brand (NDA)NDA 214902RX MAYNE PHARMA

At a glance

Jul 26, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

13

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 2021

    5 yr ago

  2. Today

  3. Patent 12156946 expires

    Listed drug product patent expiration.

    Feb 03, 2028

    in 1 yr 8 mo

  4. Patent 8617580 expires

    Listed drug product patent expiration.

    Feb 03, 2028

    in 1 yr 8 mo

  5. Patent 9868103 expires

    Listed drug product patent expiration.

    Aug 08, 2028

    in 2 yr 2 mo

  6. Patent 10653899 expires

    Listed drug product patent expiration.

    Dec 30, 2030

    in 4 yr 7 mo

  7. Patent 11071878 expires

    Listed drug product patent expiration.

    Dec 30, 2030

    in 4 yr 7 mo

  8. Patent 12070629 expires

    Listed drug product patent expiration.

    Dec 30, 2030

    in 4 yr 7 mo

  9. Patent 12053546 expires

    Listed drug product patent expiration.

    Jun 29, 2032

    in 6 yr 1 mo

  10. Patent 10420743 expires

    Listed method-of-use patent (U-3194) expiration.

    Jul 12, 2038

    in 12 yr 3 mo

  11. Patent 12357602 expires

    Listed drug product patent expiration.

    Jul 12, 2038

    in 12 yr 3 mo

  12. Patent 12295935 expires

    Listed method-of-use patent (U-3987) expiration.

    Dec 27, 2040

    in 14 yr 9 mo

  13. Patent 12133919 expires

    Listed drug product patent expiration.

    May 23, 2041

    in 15 yr 2 mo

  14. Patent 12257348 expires

    Listed drug product patent expiration.

    May 23, 2041

    in 15 yr 2 mo

  15. Patent 12491163 expires

    Listed drug product patent expiration.

    May 23, 2041

    in 15 yr 2 mo

Pharmaceutical detail

Active ingredient

BENZOYL PEROXIDE; TRETINOIN

Strength

3%;0.1%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 214902

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 (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12156946Feb 03, 2028in 1 yr 8 mo
Product
8617580Feb 03, 2028in 1 yr 8 mo
Product
9868103Aug 08, 2028in 2 yr 2 mo
ProductU-3194
10653899Dec 30, 2030in 4 yr 7 mo
ProductU-3194
11071878Dec 30, 2030in 4 yr 7 mo
Product
12070629Dec 30, 2030in 4 yr 7 mo
ProductU-3987
12053546Jun 29, 2032in 6 yr 1 mo
Product
10420743Jul 12, 2038in 12 yr 3 mo
U-3194
12357602Jul 12, 2038in 12 yr 3 mo
ProductU-3987
12295935Dec 27, 2040in 14 yr 9 mo
U-3987
12133919May 23, 2041in 15 yr 2 mo
ProductU-3987
12257348May 23, 2041in 15 yr 2 mo
ProductU-3987
12491163May 23, 2041in 15 yr 2 mo
ProductU-3987
Agent CTA Background

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