Generic competition · all medicines · read 12 November 2026
Is there a generic of Clotrimazole, and who makes it?
Clotrimazole appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 2.6 and 21.1 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Clotrimazole appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 2.6 and 21.1 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Solution, Topical
Four or more generic makers listed
Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 28 February 1995.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 28 February 1995 | 1 |
| Sun Pharma Canada Inc | 29 July 1996 | 1 |
| Novitium Pharma Llc | 14 February 2019 | 1 |
| Tp Anda Holdings Llc | 25 July 2019 | 1 |
| Sciegen Pharmaceuticals Inc | 16 October 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Cream, Vaginal
One to three generic makers listed
Brand listed as marketed: Trivagizole 3. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 16 July 1993.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Encube Ethicals Private Ltd | 16 July 1993 | 1 |
| Sun Pharma Canada Inc | 4 December 1995 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Cream, Topical
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 31 August 1993.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sun Pharma Canada Inc | 31 August 1993 | 1 |
| Fougera Pharmaceuticals Inc | 2 September 2008 | 1 |
| Glenmark Pharmaceuticals Inc Usa | 3 August 2010 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Vaginal
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed (1 generic product listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Troche/Lozenge, Oral
One to three generic makers listed
Every brand product here is listed as discontinued. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 29 July 2004.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 29 July 2004 | 1 |
| Padagis Us Llc | 28 October 2005 | 1 |
| Rising Pharma Holdings Inc | 29 February 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Cream, Tablet, Topical, Vaginal
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Lotion, Topical
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution/Drops, Otic
Brand listed, no generic listed as marketed
Brand listed as marketed: Clotic. No generic is listed as marketed.
Patents and exclusivities still listed
- 26 September 2028Exclusivity NP Clotic
- 26 September 2032Exclusivity ODE-549 Clotic
- 26 September 2033Exclusivity GAIN Clotic
- 26 September 2037Exclusivity GAIN Clotic
- 26 May 2042Patent 12246006 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.