FDA Orange Book
Is there a generic for Aplenzin?
Aplenzin contains bupropion. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aplenzin (bupropion). The Orange Book shows its last listed patent expires June 27, 2026.
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Aplenzin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 174MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 348MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 522MG | Marketed (Rx) | None | 0 | None |
NDA 022108, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aplenzin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7569610 | June 27, 2026 | Method of use | U-997 | 022108 |
| 7241805 | June 27, 2026 | Drug product | None | 022108 |
| 7645802 | June 27, 2026 | Drug product | None | 022108 |
| 7585897 | June 27, 2026 | Drug product | None | 022108 |
| 7662407 | June 27, 2026 | Drug product | None | 022108 |
| 7572935 | June 27, 2026 | Drug product | None | 022108 |
| 7649019 | June 27, 2026 | Drug product | None | 022108 |
| 7671094 | June 27, 2026 | Drug product | None | 022108 |
Aplenzin NDC codes
Questions
Is there a generic for Aplenzin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aplenzin (bupropion). The Orange Book shows its last listed patent expires June 27, 2026.
What is the generic name for Aplenzin?
The active ingredient in Aplenzin is bupropion, per the FDA Orange Book.
When does the Aplenzin patent expire?
The last patent listed for Aplenzin in the Orange Book expires June 27, 2026. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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- NDC 0187-5810Aplenzin NDC record
- NDC 0187-5811Aplenzin NDC record
- NDC 0187-5812Aplenzin NDC record