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Generic competition · all medicines · read 12 November 2026

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

Vancomycin Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 21 generic makers listed as marketed across them. 2 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 26 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.
Vancomycin Hydrochloride6 dosage-form groups in the Orange Book
21generic makers listed
  1. Vancomycin Hydrochloride appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 21 generic makers listed as marketed across them.
  2. 2 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 26 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

Generics listed, no brand listed

No brand application is listed. 13 generic makers with 49 generic products listed as marketed; the first generic approval is dated 15 March 1984.

1985199019952000200520102015202020252030013Fresenius Kabi Usa Llc, first approval 17 March 1987Hospira Inc, first approval 4 August 1988Eurofarma Inc, first approval 30 June 2008Mylan Laboratories Ltd, first approval 30 December 2008Sagent Pharmaceuticals Inc, first approval 10 August 2012Hikma Pharmaceuticals Usa Inc, first approval 28 December 2015Xellia Pharmaceuticals Aps, first approval 28 December 2015Gland Pharma Ltd, first approval 21 January 2016Eugia Pharma Specialities Ltd, first approval 29 March 2016Hikma Farmaceutica Portugal Sa, first approval 15 October 2018Hainan Poly Pharm Co Ltd, first approval 12 June 2019Aspiro Pharma Ltd, first approval 6 July 2022Meitheal Pharmaceuticals Inc, first approval 27 July 2022data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc17 March 19875
Hospira Inc4 August 19889
Eurofarma Inc30 June 20082
Mylan Laboratories Ltd30 December 20084
Sagent Pharmaceuticals Inc10 August 20122
Hikma Pharmaceuticals Usa Inc28 December 20153
Xellia Pharmaceuticals Aps28 December 20152
Gland Pharma Ltd21 January 20164
Eugia Pharma Specialities Ltd29 March 20164
Hikma Farmaceutica Portugal Sa15 October 20183
Hainan Poly Pharm Co Ltd12 June 20194
Aspiro Pharma Ltd6 July 20222

1 more makers are listed in the data.

Patents and exclusivities still listed

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

Powder, Intravenous

Four or more generic makers listed

Brand listed as marketed: Vancomycin Hydrochloride. 5 generic makers with 11 generic products listed as marketed; the first generic approval is dated 6 January 2016.

201520202025203005brand 2018Samson Medical Technologies Llc, first approval 6 January 2016Hikma Pharmaceuticals Usa Inc, first approval 29 June 2023Eugia Pharma Specialities Ltd, first approval 4 August 2023Gland Pharma Ltd, first approval 21 March 2025Steriscience Pte Ltd, first approval 2 October 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Samson Medical Technologies Llc6 January 20161
Hikma Pharmaceuticals Usa Inc29 June 20232
Eugia Pharma Specialities Ltd4 August 20232
Gland Pharma Ltd21 March 20253
Steriscience Pte Ltd2 October 20253

Patents and exclusivities still listed

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

Capsule, Oral

One to three generic makers listed

Brand listed as marketed: Vancocin Hydrochloride. 3 generic makers with 6 generic products listed as marketed; the first generic approval is dated 9 April 2012.

198519901995200020052010201520202025203003brand 1986Pai Holdings Llc Dba Pharmaceutical Associates Inc And Dba Pai Pharma, first approval 9 April 2012Strides Pharma Global Pte Ltd, first approval 9 April 2012Orient Pharma Co Ltd, first approval 29 April 2019data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Pai Holdings Llc Dba Pharmaceutical Associates Inc And Dba Pai Pharma9 April 20122
Strides Pharma Global Pte Ltd9 April 20122
Orient Pharma Co Ltd29 April 20192

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: Tyzavan and Vancomycin Hydrochloride In Plastic Container. No generic is listed as marketed.

199019952000200520102015202020252030203501brand 1993data datePatent 11517609 listed to expire 6 November 2035Patent 10039804 listed to expire 6 November 2035Patent 10188697 listed to expire 6 November 2035Patent 10849956 listed to expire 6 November 2035Patent 12161690 listed to expire 6 November 2035Patent 11628200 listed to expire 6 November 2035
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 6 November 2035Patent 11517609
  • 6 November 2035Patent 10039804 drug product
  • 6 November 2035Patent 10188697 drug product
  • 6 November 2035Patent 10849956 drug product
  • 6 November 2035Patent 12161690 drug product
  • 6 November 2035Patent 11628200 drug product

For Solution, Oral

One to three generic makers listed

Brand listed as marketed: Firvanq Kit. 3 generic makers with 5 generic products listed as marketed; the first generic approval is dated 13 July 1983.

19801985199019952000200520102015202020252030203503brand 2018Ani Pharmaceuticals Inc, first approval 13 July 1983Alkem Laboratories Ltd, first approval 14 November 2022Aurobindo Pharma Ltd, first approval 7 August 2026data datePatent 10959947 listed to expire 13 March 2035Patent 10959948 listed to expire 13 March 2035Patent 10959949 listed to expire 13 March 2035Patent 10688046 listed to expire 13 March 2035Patent 10959946 listed to expire 13 March 2035Patent 10493028 listed to expire 13 March 2035Patent 11638692 listed to expire 13 March 2035
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ani Pharmaceuticals Inc13 July 19831
Alkem Laboratories Ltd14 November 20222
Aurobindo Pharma Ltd7 August 20262

Patents and exclusivities still listed

  • 13 March 2035Patent 10959947 drug product
  • 13 March 2035Patent 10959948 drug product
  • 13 March 2035Patent 10959949 drug product
  • 13 March 2035Patent 10688046 drug product
  • 13 March 2035Patent 10959946 drug product
  • 13 March 2035Patent 10493028 drug product
  • 13 March 2035Patent 11638692 drug product

Powder, Intravenous, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Vancomycin Hydrochloride. No generic is listed as marketed.

20202025203001brand 2023data 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.