Assyro AI

Orange Book product · Brand (NDA)

QUTENZA

CAPSAICIN

Brand (NDA)NDA 022395RX AVERITAS

At a glance

Nov 16, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 16, 2009

    16 yr 10 mo ago

  2. Today

  3. Patent 9226903 expires

    Listed drug product patent expiration.

    Dec 15, 2028

    in 2 yr 6 mo

  4. Patent 8821920 expires

    Listed drug product patent expiration.

    Mar 26, 2030

    in 3 yr 10 mo

Pharmaceutical detail

Active ingredient

CAPSAICIN

Strength

8%

Dosage form

PATCH

Route

TOPICAL

TE code

Not listed

Application

NDA 022395

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9226903Dec 15, 2028in 2 yr 6 mo
Product
8821920Mar 26, 2030in 3 yr 10 mo
Product
Agent CTA Background

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