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OmniRx › Tools › Generic competition check › Clozapine

Generic competition · all medicines · read 12 November 2026

Is there a generic of Clozapine, and who makes it?

Clozapine appears in 3 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 6.9 and 11.6 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.
Clozapine3 dosage-form groups in the Orange Book
5generic makers listed
  1. Clozapine appears in 3 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 6.9 and 11.6 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.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Clozaril. 4 generic makers with 17 generic products listed as marketed; the first generic approval is dated 30 August 1996.

198519901995200020052010201520202025203004brand 1989Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa, first approval 26 November 1997Mylan Pharmaceuticals Inc, first approval 27 May 1999Accord Healthcare Inc, first approval 25 November 2015Aurobindo Pharma Ltd, first approval 29 November 2016data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa26 November 19977
Mylan Pharmaceuticals Inc27 May 19994
Accord Healthcare Inc25 November 20152
Aurobindo Pharma Ltd29 November 20164

Patents and exclusivities still listed

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

Tablet, Orally Disintegrating, Oral

One to three generic makers listed

Every brand product here is listed as discontinued. 3 generic makers with 14 generic products listed as marketed; the first generic approval is dated 15 September 2015.

200020052010201520202025203003brand 2004Mylan Pharmaceuticals Inc, first approval 15 September 2015Barr Laboratories Inc, first approval 25 November 2015Aurobindo Pharma Ltd, first approval 12 December 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Pharmaceuticals Inc15 September 20154
Barr Laboratories Inc25 November 20155
Aurobindo Pharma Ltd12 December 20245

Patents and exclusivities still listed

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

Suspension, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Versacloz. No generic is listed as marketed.

2010201520202025203001brand 2013data datePatent 8057811 listed to expire 1 May 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 May 2028Patent 8057811 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.