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OmniRx › Tools › Generic competition check › Melphalan Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Melphalan Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 generic makers listed as marketed across them. 3 groups have 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 4 and 16.6 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.
Melphalan Hydrochloride4 dosage-form groups in the Orange Book
12generic makers listed
  1. Melphalan Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 generic makers listed as marketed across them.
  2. 3 groups have 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 4 and 16.6 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, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 12 generic makers with 12 generic products listed as marketed; the first generic approval is dated 9 June 2009.

199019952000200520102015202020252030012brand 1992Mylan Institutional Llc, first approval 9 June 2009Hikma Pharmaceuticals Usa Inc, first approval 28 October 2010Actavis Llc, first approval 19 December 2016Sagent Pharmaceuticals Inc, first approval 28 February 2017Dr Reddys Laboratories Ltd, first approval 8 December 2017Fresenius Kabi Usa Llc, first approval 22 December 2017Gland Pharma Ltd, first approval 28 May 2019Quagen Pharmaceuticals Llc, first approval 13 September 2019Bpi Labs Llc, first approval 8 May 2020Meitheal Pharmaceuticals Inc, first approval 28 May 2021Hetero Labs Ltd, first approval 23 May 2024Avet Lifesciences Private Ltd, first approval 29 October 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Institutional Llc9 June 20091
Hikma Pharmaceuticals Usa Inc28 October 20101
Actavis Llc19 December 20161
Sagent Pharmaceuticals Inc28 February 20171
Dr Reddys Laboratories Ltd8 December 20171
Fresenius Kabi Usa Llc22 December 20171
Gland Pharma Ltd28 May 20191
Quagen Pharmaceuticals Llc13 September 20191
Bpi Labs Llc8 May 20201
Meitheal Pharmaceuticals Inc28 May 20211
Hetero Labs Ltd23 May 20241
Avet Lifesciences Private Ltd29 October 20241

Patents and exclusivities still listed

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

Powder, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Evomela. No generic is listed as marketed (1 generic product listed as discontinued).

2015202020252030203501brand 2016data datePatent 9200088 listed to expire 13 March 2029Patent 8410077 listed to expire 13 March 2029Patent 11020363 listed to expire 28 May 2030Patent 10864183 listed to expire 28 May 2030Patent 10940128 listed to expire 14 June 2030Patent 9493582 listed to expire 27 February 2033Patent 10040872 listed to expire 30 January 2034
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 13 March 2029Patent 9200088 drug product
  • 13 March 2029Patent 8410077 drug product
  • 28 May 2030Patent 11020363 drug product
  • 28 May 2030Patent 10864183 drug product
  • 14 June 2030Patent 10940128 drug product
  • 27 February 2033Patent 9493582 drug product
  • 30 January 2034Patent 10040872 drug product

Powder, Intra-Arterial

Brand listed, no generic listed as marketed

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

202020252030203501brand 2023data datePatent 11633528 listed to expire 7 November 2032Patent 10569004 listed to expire 7 November 2032Patent 10369264 listed to expire 7 November 2032Patent 10098997 listed to expire 7 November 2032Patent 11241522 listed to expire 7 November 2032Patent 11833286 listed to expire 30 December 2032Patent 11083831 listed to expire 30 December 2032Patent 10195334 listed to expire 16 January 2033Patent 9314561 listed to expire 7 February 2034Patent 9707331 listed to expire 17 September 2034Exclusivity ODE-438 to 14 August 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 14 August 2030Exclusivity ODE-438 Hepzato
  • 7 November 2032Patent 11633528
  • 7 November 2032Patent 10569004
  • 7 November 2032Patent 10369264 drug product
  • 7 November 2032Patent 10098997 drug product
  • 7 November 2032Patent 11241522 drug product
  • 30 December 2032Patent 11833286 drug product
  • 30 December 2032Patent 11083831 drug product
  • 16 January 2033Patent 10195334 drug product

2 more patents are listed.

Solution, Intravenous

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2023data datePatent 10537520 listed to expire 29 June 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 29 June 2036Patent 10537520 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.