Assyro AI

Orange Book product · Brand (NDA)

FORFIVO XL

BUPROPION HYDROCHLORIDE

Brand (NDA)NDA 022497RX TWI PHARMS

At a glance

Nov 10, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 10, 2011

    14 yr 10 mo ago

  2. Today

  3. Patent 7674479 expires

    Listed drug product patent expiration.

    Aug 23, 2028

    in 2 yr 3 mo

Pharmaceutical detail

Active ingredient

BUPROPION HYDROCHLORIDE

Strength

450MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022497

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 (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7674479Aug 23, 2028in 2 yr 3 mo
Product
Agent CTA Background

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