FDA Orange Book
Generic for Differin
Differin contains adapalene. 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 Differin is adapalene. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Differin products the Orange Book lists.
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Differin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.1% | Marketed (Rx) | AB | 1 | AB |
| gel, topical | 0.3% | Marketed (Rx) | AB | 4 | AB |
| lotion, topical | 0.1% | Discontinued | None | 0 | None |
| solution, topical | 0.1% | Discontinued | None | 2 | AB |
NDA 020748, 021753, 022502, 020338, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic adapalene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 090824 | AB (A-rated, therapeutically equivalent) | June 30, 2010 | 0.1% |
| ENCUBE ETHICALS PVT LTD | 200298 | AB (A-rated, therapeutically equivalent) | June 14, 2012 | 0.3% |
| ACTAVIS MID ATLANTIC LLC | 201000 | AB (A-rated, therapeutically equivalent) | October 27, 2014 | 0.3% |
| WAYLIS THERAPEUTICS LLC | 204593 | AB (A-rated, therapeutically equivalent) | January 5, 2016 | 0.1% |
| SUN PHARMA CANADA INC | 208322 | AB (A-rated, therapeutically equivalent) | June 23, 2016 | 0.3% |
| WAYLIS THERAPEUTICS LLC | 203981 | AB (A-rated, therapeutically equivalent) | September 23, 2016 | 0.1% |
| ALEMBIC PHARMACEUTICALS LTD | 213508 | AB (A-rated, therapeutically equivalent) | June 18, 2020 | 0.3% |
Differin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8435502 | September 15, 2026 | Drug product | U-1078 | 022502 |
| 8709392 | September 15, 2026 | Drug product | U-1078 | 022502 |
| 7998467 | May 31, 2028 | Drug product | U-1078 | 022502 |
Differin NDC codes
Questions
Is there a generic for Differin?
Yes. The generic name for Differin is adapalene. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Differin products the Orange Book lists.
What is the generic name for Differin?
The active ingredient in Differin is adapalene, per the FDA Orange Book.
When does the Differin patent expire?
The last patent listed for Differin in the Orange Book expires May 31, 2028. 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.