FDA Orange Book
Is there a generic for Zubsolv?
Zubsolv contains buprenorphine and naloxone. 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 Zubsolv (buprenorphine and naloxone). The Orange Book shows its last listed patent expires September 18, 2032.
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Zubsolv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, sublingual | EQ 0.7MG BASE;EQ 0.18MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, sublingual | EQ 1.4MG BASE;EQ 0.36MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, sublingual | EQ 11.4MG BASE;EQ 2.9MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, sublingual | EQ 2.9MG BASE;EQ 0.71MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, sublingual | EQ 5.7MG BASE;EQ 1.4MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, sublingual | EQ 8.6MG BASE;EQ 2.1MG BASE | Marketed (Rx) | None | 0 | None |
NDA 204242, held by EDENBRIDGE PHARMACEUTICALS LLC DBA DEXCEL PHARMA USA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zubsolv patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8658198 | December 3, 2027 | Drug product | U-1494 | 204242 |
| 8470361 | May 22, 2030 | Drug product | U-1425 | 204242 |
| 11020388 | September 18, 2032 | Drug product | U-3131 | 204242 |
| 10946010 | September 18, 2032 | Drug product | None | 204242 |
| 9259421 | September 18, 2032 | Drug product | None | 204242 |
| 8940330 | September 18, 2032 | Drug product | None | 204242 |
| 11433066 | September 18, 2032 | Method of use | U-3131 | 204242 |
| 9439900 | September 18, 2032 | Drug product | None | 204242 |
| 11020387 | September 18, 2032 | Drug product | U-3131 | 204242 |
| 10874661 | September 18, 2032 | Drug product | None | 204242 |
Zubsolv NDC codes
Questions
Is there a generic for Zubsolv?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zubsolv (buprenorphine and naloxone). The Orange Book shows its last listed patent expires September 18, 2032.
What is the generic name for Zubsolv?
The active ingredient in Zubsolv is buprenorphine and naloxone, per the FDA Orange Book.
When does the Zubsolv patent expire?
The last patent listed for Zubsolv in the Orange Book expires September 18, 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 Zubsolv and Buprenorphine and Naloxone
- What is Zubsolv used for?FDA label uses
- Is Zubsolv a controlled substance?Schedule III
- What is Buprenorphine and Naloxone used for?FDA label uses
- Is Buprenorphine and Naloxone a controlled substance?Schedule III
- Generic for SuboxoneFDA Orange Book
- Opioid Antagonists listFDA drug class
- Partial Opioid Agonists listFDA drug class
- Zubsolv Medicare Part D coverageBy plan and state
- NDC 54123-114Zubsolv NDC record
- NDC 54123-907Zubsolv NDC record
- NDC 54123-914Zubsolv NDC record
- Schedule III drugs listDEA schedule