Assyro AI

Orange Book product · Brand (NDA)

APLENZIN

BUPROPION HYDROBROMIDE

Brand (NDA)NDA 022108RX BAUSCH

At a glance

Apr 23, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

8

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 23, 2008

    18 yr 5 mo ago

  2. Today

  3. Patent 7241805 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  4. Patent 7569610 expires

    Listed method-of-use patent (U-997) expiration.

    Jun 27, 2026

    in 8 d

  5. Patent 7572935 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  6. Patent 7585897 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  7. Patent 7645802 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  8. Patent 7649019 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  9. Patent 7662407 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

  10. Patent 7671094 expires

    Listed drug product patent expiration.

    Jun 27, 2026

    in 8 d

Pharmaceutical detail

Active ingredient

BUPROPION HYDROBROMIDE

Strength

174MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022108

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 (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7241805Jun 27, 2026in 8 d
Product
7569610Jun 27, 2026in 8 d
U-997
7572935Jun 27, 2026in 8 d
Product
7585897Jun 27, 2026in 8 d
Product
7645802Jun 27, 2026in 8 d
Product
7649019Jun 27, 2026in 8 d
Product
7662407Jun 27, 2026in 8 d
Product
7671094Jun 27, 2026in 8 d
Product
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