FDA Orange Book · active-ingredient family
Bupropion hydrobromide
Bupropion hydrobromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:APLENZIN · NDA 022108
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APLENZINRLD×3 | BAUSCH | NDA 022108 | — | Apr 23, 2008 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7569610 | Jun 27, 2026 | in 8 d | U-997 |
| 7241805 | Jun 27, 2026 | in 8 d | Product |
| 7645802 | Jun 27, 2026 | in 8 d | Product |
| 7585897 | Jun 27, 2026 | in 8 d | Product |
| 7662407 | Jun 27, 2026 | in 8 d | Product |
| 7572935 | Jun 27, 2026 | in 8 d | Product |
| 7649019 | Jun 27, 2026 | in 8 d | Product |
| 7671094 | Jun 27, 2026 | in 8 d | Product |
Bupropion hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

