Assyro AI

Orange Book product · Brand (NDA)

SECUADO

ASENAPINE

Brand (NDA)NDA 212268RX HISAMITSU

At a glance

Oct 11, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

6

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 11, 2019

    6 yr 9 mo ago

  2. Today

  3. Patent 10022445 expires

    Listed drug product patent expiration.

    Jul 25, 2033

    in 7 yr 2 mo

  4. Patent 10583121 expires

    Listed drug product patent expiration.

    Jul 25, 2033

    in 7 yr 2 mo

  5. Patent 10814002 expires

    Listed drug product patent expiration.

    Jul 25, 2033

    in 7 yr 2 mo

  6. Patent 11123305 expires

    Listed drug product patent expiration.

    Jul 25, 2033

    in 7 yr 2 mo

  7. Patent 9687474 expires

    Listed drug product patent expiration.

    Jul 25, 2033

    in 7 yr 2 mo

  8. Patent 11813364 expires

    Listed drug product patent expiration.

    Sep 22, 2033

    in 7 yr 4 mo

Pharmaceutical detail

Active ingredient

ASENAPINE

Strength

3.8MG/24HR

Dosage form

SYSTEM

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 212268

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 (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10022445Jul 25, 2033in 7 yr 2 mo
Product
10583121Jul 25, 2033in 7 yr 2 mo
ProductU-2763
10814002Jul 25, 2033in 7 yr 2 mo
ProductU-2763
11123305Jul 25, 2033in 7 yr 2 mo
Product
9687474Jul 25, 2033in 7 yr 2 mo
Product
11813364Sep 22, 2033in 7 yr 4 mo
Product
Agent CTA Background

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