FDA Orange Book
Generic for Suboxone
Suboxone 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
Yes. The generic name for Suboxone is buprenorphine and naloxone. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Suboxone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, buccal, sublingual | EQ 12MG BASE;EQ 3MG BASE | Marketed (Rx) | AB | 5 | AB |
| film, buccal, sublingual | EQ 2MG BASE;EQ 0.5MG BASE | Marketed (Rx) | AB | 5 | AB |
| film, buccal, sublingual | EQ 4MG BASE;EQ 1MG BASE | Marketed (Rx) | AB | 5 | AB |
| film, buccal, sublingual | EQ 8MG BASE;EQ 2MG BASE | Marketed (Rx) | AB | 5 | AB |
| tablet, sublingual | EQ 2MG BASE;EQ 0.5MG BASE | Discontinued | None | 11 | AB |
| tablet, sublingual | EQ 8MG BASE;EQ 2MG BASE | Discontinued | None | 11 | AB |
NDA 022410, 020733, held by INDIVIOR INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic buprenorphine and naloxone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 091422 | AB (A-rated, therapeutically equivalent) | February 22, 2013 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 203136 | AB (A-rated, therapeutically equivalent) | February 22, 2013 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 203326 | AB (A-rated, therapeutically equivalent) | June 27, 2014 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| ETHYPHARM INC | 204431 | AB (A-rated, therapeutically equivalent) | October 16, 2015 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 201633 | AB (A-rated, therapeutically equivalent) | August 5, 2016 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| LANNETT CO INC | 205022 | AB (A-rated, therapeutically equivalent) | September 19, 2016 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| SPECGX LLC | 207000 | AB (A-rated, therapeutically equivalent) | December 13, 2017 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| DR REDDYS LABORATORIES SA | 205806 | AB (A-rated, therapeutically equivalent) | June 14, 2018 | EQ 12MG BASE;EQ 3MG BASE, EQ 4MG BASE;EQ 1MG BASE |
| MYLAN TECHNOLOGIES INC | 207607 | AB (A-rated, therapeutically equivalent) | June 14, 2018 | EQ 12MG BASE;EQ 3MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| DR REDDYS LABORATORIES SA | 205299 | AB (A-rated, therapeutically equivalent) | June 14, 2018 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| ALVOGEN INC | 205954 | AB (A-rated, therapeutically equivalent) | January 24, 2019 | EQ 12MG BASE;EQ 3MG BASE, EQ 2MG BASE;EQ 0.5MG BASE, EQ 4MG BASE;EQ 1MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| RHODES PHARMACEUTICALS LP | 205601 | AB (A-rated, therapeutically equivalent) | March 30, 2020 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| MYLAN TECHNOLOGIES INC | 211785 | AB (A-rated, therapeutically equivalent) | April 17, 2020 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 4MG BASE;EQ 1MG BASE |
| WES PHARMA INC | 209069 | AB (A-rated, therapeutically equivalent) | July 17, 2020 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| ALKEM LABORATORIES LTD | 214930 | AB (A-rated, therapeutically equivalent) | June 15, 2021 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| DIFGEN PHARMACEUTICALS LLC | 212756 | AB (A-rated, therapeutically equivalent) | June 2, 2022 | EQ 12MG BASE;EQ 3MG BASE, EQ 2MG BASE;EQ 0.5MG BASE, EQ 4MG BASE;EQ 1MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| ASCENT PHARMACEUTICALS INC | 219727 | AB (A-rated, therapeutically equivalent) | December 15, 2025 | EQ 2MG BASE;EQ 0.5MG BASE, EQ 8MG BASE;EQ 2MG BASE |
| ASCENT PHARMACEUTICALS INC | 219850 | AB (A-rated, therapeutically equivalent) | January 21, 2026 | EQ 12MG BASE;EQ 3MG BASE, EQ 2MG BASE;EQ 0.5MG BASE, EQ 4MG BASE;EQ 1MG BASE, EQ 8MG BASE;EQ 2MG BASE |
Suboxone patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9687454 | August 7, 2029 | Drug product | U-1464 | 022410 |
| 11135216 | August 7, 2029 | Drug product | U-3111 | 022410 |
| 8475832 | March 26, 2030 | Drug product | U-1411 | 022410 |
Suboxone NDC codes
Questions
Is there a generic for Suboxone?
Yes. The generic name for Suboxone is buprenorphine and naloxone. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Suboxone?
The active ingredient in Suboxone is buprenorphine and naloxone, per the FDA Orange Book.
When does the Suboxone patent expire?
The last patent listed for Suboxone in the Orange Book expires March 26, 2030. 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 Suboxone and Buprenorphine and Naloxone
- What is Suboxone used for?FDA label uses
- Is Suboxone a controlled substance?Schedule III
- What is Buprenorphine and Naloxone used for?FDA label uses
- Is Buprenorphine and Naloxone a controlled substance?Schedule III
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- Schedule III drugs listDEA schedule