FDA Orange Book
Generic for Aczone
Aczone contains dapsone. 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 Aczone is dapsone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Aczone products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 5% | Marketed (Rx) | AB | 7 | AB |
| gel, topical | 7.5% | Marketed (Rx) | AB | 6 | AB |
NDA 021794, 207154, held by ALMIRALL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dapsone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 209506 | AB (A-rated, therapeutically equivalent) | October 16, 2017 | 5% |
| SUN PHARMA CANADA INC | 210191 | AB (A-rated, therapeutically equivalent) | June 26, 2019 | 7.5% |
| MYLAN PHARMACEUTICALS INC | 213847 | AB (A-rated, therapeutically equivalent) | February 4, 2022 | 7.5% |
| TORRENT PHARMACEUTICALS LTD | 214722 | AB (A-rated, therapeutically equivalent) | February 10, 2022 | 7.5% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 210178 | AB (A-rated, therapeutically equivalent) | March 31, 2022 | 5% |
| TP ANDA HOLDINGS LLC | 213907 | AB (A-rated, therapeutically equivalent) | June 6, 2023 | 5% |
| ENCUBE ETHICALS PRIVATE LTD | 212383 | AB (A-rated, therapeutically equivalent) | October 13, 2023 | 5% |
| AMNEAL PHARMACEUTICALS LLC | 209890 | AB (A-rated, therapeutically equivalent) | October 19, 2023 | 5% |
| ALEMBIC PHARMACEUTICALS LTD | 215718 | AB (A-rated, therapeutically equivalent) | October 27, 2023 | 7.5% |
| ZYDUS LIFESCIENCES GLOBAL FZE | 214019 | AB (A-rated, therapeutically equivalent) | May 8, 2024 | 7.5% |
| TP ANDA HOLDINGS LLC | 213636 | AB (A-rated, therapeutically equivalent) | August 26, 2024 | 7.5% |
| AUROBINDO PHARMA LTD | 218457 | AB (A-rated, therapeutically equivalent) | April 4, 2025 | 5% |
| ALEMBIC PHARMACEUTICALS LTD | 213414 | AB (A-rated, therapeutically equivalent) | June 25, 2026 | 5% |
Aczone patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11273132 | November 18, 2033 | Drug product | None | 207154 |
Aczone NDC codes
Questions
Is there a generic for Aczone?
Yes. The generic name for Aczone is dapsone. 10 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 Aczone?
The active ingredient in Aczone is dapsone, per the FDA Orange Book.
When does the Aczone patent expire?
The last patent listed for Aczone in the Orange Book expires November 18, 2033. 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.