Assyro AI

Orange Book product · Brand (NDA)

YCANTH

CANTHARIDIN

Brand (NDA)NDA 212905RX VERRICA PHARMS

At a glance

Jul 21, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 21, 2023

    2 yr 11 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Jul 21, 2028

    in 2 yr 1 mo

  4. Patent 11052064 expires

    Listed drug product patent expiration.

    May 28, 2035

    in 9 yr 1 mo

  5. Patent 11052064 expires

    Listed drug product patent expiration.

    May 28, 2035

    in 9 yr 1 mo

  6. Patent 11147790 expires

    Listed drug product patent expiration.

    Aug 22, 2038

    in 12 yr 4 mo

  7. Patent 11147790 expires

    Listed drug product patent expiration.

    Aug 22, 2038

    in 12 yr 4 mo

  8. Patent 12233042 expires

    Listed drug product patent expiration.

    Aug 22, 2038

    in 12 yr 4 mo

  9. Patent 12290651 expires

    Listed drug product patent expiration.

    Feb 19, 2041

    in 14 yr 11 mo

Pharmaceutical detail

Active ingredient

CANTHARIDIN

Strength

0.7%

Dosage form

SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 212905

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)

  • NCENew chemical entity exclusivity (5 years)

    Jul 21, 2028

    in 2 yr 1 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11052064May 28, 2035in 9 yr 1 mo
ProductU-3665
11052064May 28, 2035in 9 yr 1 mo
ProductU-3663
11147790Aug 22, 2038in 12 yr 4 mo
ProductU-3663
11147790Aug 22, 2038in 12 yr 4 mo
ProductU-3664
12233042Aug 22, 2038in 12 yr 4 mo
ProductU-3663
12290651Feb 19, 2041in 14 yr 11 mo
Product
Agent CTA Background

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