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OmniRx › Tools › Generic competition check › Argatroban

Generic competition · all medicines · read 12 November 2026

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

Argatroban appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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 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.
Argatroban3 dosage-form groups in the Orange Book
6generic makers listed
  1. Argatroban appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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 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.

Injectable, Injection

Four or more generic makers listed

Brand listed as marketed: Argatroban. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 30 June 2014.

200020052010201520202025203006brand 2000Mylan Institutional Llc, first approval 30 June 2014Ph Health Ltd, first approval 30 June 2014Hospira Inc, first approval 21 September 2016Amneal Pharmaceuticals Co Gmbh, first approval 26 January 2018Caplin Steriles Ltd, first approval 21 January 2021Gland Pharma Ltd, first approval 31 July 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Institutional Llc30 June 20141
Ph Health Ltd30 June 20141
Hospira Inc21 September 20161
Amneal Pharmaceuticals Co Gmbh26 January 20181
Caplin Steriles Ltd21 January 20211
Gland Pharma Ltd31 July 20231

Patents and exclusivities still listed

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

Injectable, Intravenous

One to three generic makers listed

Brand listed as marketed: Argatroban In Sodium Chloride. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 22 May 2017.

2010201520202025203001brand 2011Gland Pharma Ltd, first approval 22 May 2017data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Gland Pharma Ltd22 May 20171

Patents and exclusivities still listed

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

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Argatroban In Sodium Chloride. No generic is listed as marketed.

2010201520202025203001brand 2011data 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.