FDA Orange Book
Generic for Olux E
Olux E contains clobetasol propionate. 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 Olux E is clobetasol propionate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Olux E products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 0.05% | Discontinued | None | 7 | AB1, AB2 |
NDA 022013, held by QUAGEN PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clobetasol propionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 077763 | AB1 (A-rated, therapeutically equivalent) | March 10, 2008 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 201402 | AB2 (A-rated, therapeutically equivalent) | August 14, 2012 | 0.05% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 208779 | AB1 (A-rated, therapeutically equivalent) | October 4, 2018 | 0.05% |
| GLENMARK PHARMACEUTICALS LTD | 210809 | AB1 (A-rated, therapeutically equivalent) | February 15, 2019 | 0.05% |
| GLENMARK PHARMACEUTICALS LTD | 211450 | AB2 (A-rated, therapeutically equivalent) | September 9, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 215838 | AB1 (A-rated, therapeutically equivalent) | April 21, 2022 | 0.05% |
| XIROMED PHARMA ESPANA SL | 210638 | AB1 (A-rated, therapeutically equivalent) | November 20, 2025 | 0.05% |
Olux E patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8460641 | November 5, 2028 | Drug product | U-1410 | 022013 |
Questions
Is there a generic for Olux E?
Yes. The generic name for Olux E is clobetasol propionate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Olux E?
The active ingredient in Olux E is clobetasol propionate, per the FDA Orange Book.
When does the Olux E patent expire?
The last patent listed for Olux E in the Orange Book expires November 5, 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.