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OmniRx › Tools › Generic competition check › Bivalirudin

Generic competition · all medicines · read 12 November 2026

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

Bivalirudin appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 14.6 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.
Bivalirudin2 dosage-form groups in the Orange Book
7generic makers listed
  1. Bivalirudin appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 7 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 14.6 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.

Injectable, Intravenous

Four or more generic makers listed

Brand listed as marketed: Angiomax. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 14 July 2015.

200020052010201520202025203007brand 2000Fresenius Kabi Usa Llc, first approval 28 October 2016Dr Reddys Laboratories Ltd, first approval 26 May 2017Accord Healthcare Inc, first approval 22 November 2017Mylan Institutional Llc, first approval 1 June 2018Meitheal Pharmaceuticals Inc, first approval 16 July 2018Hainan Shuangcheng Pharmaceuticals Co Ltd, first approval 23 October 2019Hainan Poly Pharm Co Ltd, first approval 28 May 2021data datePatent 7582727 listed to expire 27 July 2028Patent 7598343 listed to expire 27 July 2028Patent 7582727*PED listed to expire 27 January 2029Patent 7598343*PED listed to expire 27 January 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc28 October 20161
Dr Reddys Laboratories Ltd26 May 20171
Accord Healthcare Inc22 November 20171
Mylan Institutional Llc1 June 20181
Meitheal Pharmaceuticals Inc16 July 20181
Hainan Shuangcheng Pharmaceuticals Co Ltd23 October 20191
Hainan Poly Pharm Co Ltd28 May 20211

Patents and exclusivities still listed

  • 27 July 2028Patent 7582727 drug product
  • 27 July 2028Patent 7598343 drug product
  • 27 January 2029Patent 7582727*PED
  • 27 January 2029Patent 7598343*PED

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Angiomax Rtu. No generic is listed as marketed.

20152020202520302035204001brand 2017data datePatent 11903993 listed to expire 20 May 2039Patent 12472224 listed to expire 20 May 2039Patent 11918622 listed to expire 20 May 2039Patent 11992514 listed to expire 20 May 2039
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 May 2039Patent 11903993
  • 20 May 2039Patent 12472224 drug product
  • 20 May 2039Patent 11918622
  • 20 May 2039Patent 11992514 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.