FDA Orange Book
Is there a generic for Belbuca?
Belbuca contains buprenorphine. 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 Belbuca (buprenorphine). The Orange Book shows its last listed patent expires December 21, 2032.
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Belbuca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, buccal | EQ 0.075MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.15MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.3MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.45MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.6MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
| film, buccal | EQ 0.9MG BASE | Marketed (Rx) | None | 0 | None |
NDA 207932, held by BIODELIVERY SCIENCES INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Belbuca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9655843 | July 23, 2027 | Drug product | U-1556 | 207932 |
| 8147866 | July 23, 2027 | Drug product | U-1769 | 207932 |
| 9901539 | December 21, 2032 | Method of use | U-1556 | 207932 |
Belbuca NDC codes
Questions
Is there a generic for Belbuca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Belbuca (buprenorphine). The Orange Book shows its last listed patent expires December 21, 2032.
What is the generic name for Belbuca?
The active ingredient in Belbuca is buprenorphine, per the FDA Orange Book.
When does the Belbuca patent expire?
The last patent listed for Belbuca in the Orange Book expires December 21, 2032. 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.
More on Belbuca and Buprenorphine
- What is Belbuca used for?FDA label uses
- Is Belbuca a controlled substance?Schedule III
- What is Buprenorphine used for?FDA label uses
- Is Buprenorphine a controlled substance?Schedule III
- Generic for ButransFDA Orange Book
- Generic for BuprenexFDA Orange Book
- Generic for BrixadiFDA Orange Book
- Generic for SublocadeFDA Orange Book
- Generic for SubutexFDA Orange Book
- Partial Opioid Agonists listFDA drug class
- NDC 59385-021Belbuca NDC record
- NDC 59385-022Belbuca NDC record
- NDC 59385-023Belbuca NDC record
- Schedule III drugs listDEA schedule