FDA Orange Book
Generic for Topicort
Topicort contains desoximetasone. 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 Topicort is desoximetasone. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Topicort products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.25% | Discontinued | None | 7 | AB |
| gel, topical | 0.05% | Discontinued | None | 3 | AB |
| ointment, topical | 0.05% | Marketed (Rx) | AB | 2 | AB |
| ointment, topical | 0.25% | Discontinued | None | 8 | AB |
| spray, topical | 0.25% | Marketed (Rx) | AT | 2 | AT |
NDA 017856, 018586, 018594, 018763, 204141, held by TARO PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desoximetasone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 073193 | AB (A-rated, therapeutically equivalent) | November 30, 1990 | 0.25% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 074904 | AB (A-rated, therapeutically equivalent) | July 14, 1998 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076510 | AB (A-rated, therapeutically equivalent) | July 1, 2003 | 0.25% |
| FOUGERA PHARMACEUTICALS INC | 078369 | AB (A-rated, therapeutically equivalent) | June 29, 2010 | 0.25% |
| EPIC PHARMA LLC | 090727 | AB (A-rated, therapeutically equivalent) | March 10, 2011 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 078657 | AB (A-rated, therapeutically equivalent) | September 28, 2012 | 0.25% |
| EPIC PHARMA LLC | 201005 | AB (A-rated, therapeutically equivalent) | April 24, 2014 | 0.25% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 077770 | AB (A-rated, therapeutically equivalent) | April 20, 2015 | 0.25% |
| SCIEGEN PHARMACEUTICALS INC | 203234 | AB (A-rated, therapeutically equivalent) | June 12, 2015 | 0.25% |
| NOVEL LABORATORIES INC | 206792 | AB (A-rated, therapeutically equivalent) | May 10, 2016 | 0.25% |
| RISING PHARMA HOLDINGS INC | 204675 | AB (A-rated, therapeutically equivalent) | August 12, 2016 | 0.05% |
| ACTAVIS MID ATLANTIC LLC | 204965 | AB (A-rated, therapeutically equivalent) | November 7, 2016 | 0.25% |
| RISING PHARMA HOLDINGS INC | 204272 | AB (A-rated, therapeutically equivalent) | November 30, 2016 | 0.25% |
| LUPIN INC | 208104 | AB (A-rated, therapeutically equivalent) | December 1, 2016 | 0.25% |
| LUPIN INC | 208044 | AB (A-rated, therapeutically equivalent) | December 12, 2016 | 0.05% |
| LUPIN INC | 208164 | AB (A-rated, therapeutically equivalent) | January 9, 2017 | 0.25% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 206441 | AT (A-rated, therapeutically equivalent) | January 20, 2017 | 0.25% |
| ZYDUS LIFESCIENCES LTD | 205206 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 0.25% |
| LUPIN INC | 208124 | AT (A-rated, therapeutically equivalent) | March 16, 2018 | 0.25% |
| RISING PHARMA HOLDINGS INC | 205594 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | 0.25% |
| ZYDUS LIFESCIENCES LTD | 205620 | AB (A-rated, therapeutically equivalent) | September 28, 2018 | 0.25% |
| THE J MOLNER CO OU | 209973 | AB (A-rated, therapeutically equivalent) | October 23, 2018 | 0.05% |
Topicort patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8715624 | May 26, 2026 | Drug product | U-1408 | 204141 |
| 8277780 | September 1, 2028 | Drug product | U-1408 | 204141 |
Topicort NDC codes
Questions
Is there a generic for Topicort?
Yes. The generic name for Topicort is desoximetasone. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Topicort?
The active ingredient in Topicort is desoximetasone, per the FDA Orange Book.
When does the Topicort patent expire?
The last patent listed for Topicort in the Orange Book expires September 1, 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.