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OmniRx › Tools › Generic competition check › Bendamustine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Bendamustine Hydrochloride, and who makes it?

Bendamustine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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 14.7 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.
Bendamustine Hydrochloride2 dosage-form groups in the Orange Book
4generic makers listed
  1. Bendamustine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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 14.7 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.

Powder, Intravenous

Four or more generic makers listed

Brand listed as marketed: Treanda. 4 generic makers with 8 generic products listed as marketed; the first generic approval is dated 7 December 2022.

200520102015202020252030203504brand 2008Accord Healthcare Inc, first approval 7 December 2022Dr Reddys Laboratories Ltd, first approval 7 December 2022Eugia Pharma Specialities Ltd, first approval 5 June 2023Meitheal Pharmaceuticals Inc, first approval 5 June 2023data datePatent 8445524 listed to expire 26 March 2029Patent 9533955 listed to expire 26 March 2029Patent 8669279 listed to expire 26 March 2029Patent 8883836 listed to expire 26 March 2029Patent 8445524*PED listed to expire 26 September 2029Patent 8883836*PED listed to expire 26 September 2029Patent 8669279*PED listed to expire 26 September 2029Patent 9533955*PED listed to expire 26 September 2029Patent 8436190 listed to expire 26 October 2030Patent 8436190*PED listed to expire 26 April 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Accord Healthcare Inc7 December 20222
Dr Reddys Laboratories Ltd7 December 20222
Eugia Pharma Specialities Ltd5 June 20232
Meitheal Pharmaceuticals Inc5 June 20232

Patents and exclusivities still listed

  • 26 March 2029Patent 8445524 drug substance
  • 26 March 2029Patent 9533955 drug product
  • 26 March 2029Patent 8669279 drug product
  • 26 March 2029Patent 8883836 drug product
  • 26 September 2029Patent 8445524*PED
  • 26 September 2029Patent 8883836*PED
  • 26 September 2029Patent 8669279*PED
  • 26 September 2029Patent 9533955*PED

2 more patents are listed.

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Belrapzo, Bendamustine Hydrochloride, Bendeka and Gobarden. No generic is listed as marketed.

2010201520202025203020352040204501brand 2013data datePatent 9572796 listed to expire 28 January 2031Patent 9572797 listed to expire 28 January 2031Patent 11103483 listed to expire 28 January 2031Patent 12350257 listed to expire 28 January 2031Patent 11844783 listed to expire 28 January 2031Patent 10010533 listed to expire 28 January 2031Patent 11872214 listed to expire 28 January 2031Patent 12138248 listed to expire 28 January 2031Patent 9265831 listed to expire 28 January 2031Patent 8609707 listed to expire 11 August 2031Patent 9144568 listed to expire 15 March 2033Patent 10052385 listed to expire 15 March 2033Patent 9597399 listed to expire 15 March 2033Patent 9034908 listed to expire 15 March 2033Patent 9597397 listed to expire 15 March 2033Patent 9572887 listed to expire 15 March 2033Patent 9579384 listed to expire 15 March 2033Patent 9000021 listed to expire 15 March 2033Patent 9597398 listed to expire 15 March 2033Patent 12419867 listed to expire 29 July 2042Patent 12208086 listed to expire 29 July 2042Patent 11844784 listed to expire 29 July 2042Patent 11707450 listed to expire 29 July 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 28 January 2031Patent 9572796 drug product
  • 28 January 2031Patent 9572797
  • 28 January 2031Patent 11103483 drug product
  • 28 January 2031Patent 12350257 drug product
  • 28 January 2031Patent 11844783
  • 28 January 2031Patent 10010533 drug product
  • 28 January 2031Patent 11872214 drug product
  • 28 January 2031Patent 12138248 drug product

15 more patents are listed.

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.