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OmniRx › Tools › Generic competition check › Halobetasol Propionate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Halobetasol Propionate, and who makes it?

Halobetasol Propionate appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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 4.6 and 14 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.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Halobetasol Propionate4 dosage-form groups in the Orange Book
5generic makers listed
  1. Halobetasol Propionate appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 generic makers listed as marketed across them.
  2. 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.
  3. Where both are dated, the first generic approval came between 4.6 and 14 years after the first brand approval.
  4. 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.

Ointment, Topical

Four or more generic makers listed

Every brand product here is listed as discontinued. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 16 December 2004.

19901995200020052010201520202025203004brand 1990Padagis Israel Pharmaceuticals Ltd, first approval 16 December 2004Cosette Pharmaceuticals Nc Laboratories Llc, first approval 14 June 2005Encube Ethicals Private Ltd, first approval 20 March 2018Quagen Pharmaceuticals Llc, first approval 6 October 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Padagis Israel Pharmaceuticals Ltd16 December 20041
Cosette Pharmaceuticals Nc Laboratories Llc14 June 20051
Encube Ethicals Private Ltd20 March 20181
Quagen Pharmaceuticals Llc6 October 20201

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 16 December 2004.

19901995200020052010201520202025203003brand 1990Fougera Pharmaceuticals Inc, first approval 16 December 2004Padagis Israel Pharmaceuticals Ltd, first approval 16 December 2004Cosette Pharmaceuticals Nc Laboratories Llc, first approval 24 April 2007data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fougera Pharmaceuticals Inc16 December 20041
Padagis Israel Pharmaceuticals Ltd16 December 20041
Cosette Pharmaceuticals Nc Laboratories Llc24 April 20071

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Lotion, Topical

Brand listed, no generic listed as marketed

Brand listed as marketed: Bryhali and Ultravate. No generic is listed as marketed (1 generic product listed as discontinued).

2015202020252030203501brand 2015data datePatent 10478502 listed to expire 2 November 2031Patent 11986527 listed to expire 2 November 2031Patent 11839656 listed to expire 2 November 2031Patent 11957753 listed to expire 2 November 2031Patent 12076403 listed to expire 2 November 2031Patent 8809307 listed to expire 2 November 2031Patent 8962028 listed to expire 19 June 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 2 November 2031Patent 10478502 drug product
  • 2 November 2031Patent 11986527
  • 2 November 2031Patent 11839656
  • 2 November 2031Patent 11957753 drug product
  • 2 November 2031Patent 12076403 drug product
  • 2 November 2031Patent 8809307 drug product
  • 19 June 2033Patent 8962028 drug product

Aerosol, Foam, Topical

One to three generic makers listed

Every brand product here is listed as discontinued. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 11 August 2023.

201520202025203001brand 2018Padagis Israel Pharmaceuticals Ltd, first approval 11 August 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Padagis Israel Pharmaceuticals Ltd11 August 20231

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

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.