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Generic competition · all medicines · read 12 November 2026

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

Nizatidine appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 5.5 and 14.2 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.
Nizatidine3 dosage-form groups in the Orange Book
3generic makers listed
  1. Nizatidine appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 5.5 and 14.2 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.

Capsule, Oral

One to three generic makers listed

Every brand product here is listed as discontinued. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 5 July 2002.

198519901995200020052010201520202025203003brand 1988Epic Pharma Llc, first approval 5 July 2002Watson Laboratories Inc, first approval 9 July 2002Dr Reddys Laboratories Ltd, first approval 15 September 2005data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Epic Pharma Llc5 July 20022
Watson Laboratories Inc9 July 20022
Dr Reddys Laboratories Ltd15 September 20052

Patents and exclusivities still listed

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

Solution, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed (1 generic product listed as discontinued).

200020052010201520202025203001brand 2004data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

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

Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Axid Ar. No generic is listed as marketed.

1995200020052010201520202025203001brand 1996data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

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.