Assyro AI

Orange Book product · Brand (NDA)

XELSTRYM

DEXTROAMPHETAMINE

Brand (NDA)NDA 215401RX NOVEN PHARMS INC

At a glance

Mar 22, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 22, 2022

    4 yr 4 mo ago

  2. Today

  3. Patent 9456993 expires

    Listed drug product patent expiration.

    Oct 24, 2033

    in 7 yr 5 mo

  4. Patent 9474722 expires

    Listed drug product patent expiration.

    Oct 24, 2033

    in 7 yr 5 mo

  5. Patent 11559501 expires

    Listed drug product patent expiration.

    Jan 06, 2042

    in 15 yr 9 mo

Pharmaceutical detail

Active ingredient

DEXTROAMPHETAMINE

Strength

4.5MG/9HR

Dosage form

SYSTEM

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 215401

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9456993Oct 24, 2033in 7 yr 5 mo
ProductU-3340
9474722Oct 24, 2033in 7 yr 5 mo
Product
11559501Jan 06, 2042in 15 yr 9 mo
Product
Agent CTA Background

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