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OmniRx › Tools › Generic competition check › Tizanidine Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Tizanidine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 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 5.6 and 9.4 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.
Tizanidine Hydrochloride3 dosage-form groups in the Orange Book
17generic makers listed
  1. Tizanidine Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 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 5.6 and 9.4 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.

Capsule, Oral

Four or more generic makers listed

Brand listed as marketed: Zanaflex. 10 generic makers with 30 generic products listed as marketed; the first generic approval is dated 3 February 2012.

2000200520102015202020252030010brand 2002Apotex Inc, first approval 3 February 2012Zydus Pharmaceuticals Usa Inc, first approval 3 March 2017Jubilant Generics Ltd, first approval 4 August 2017Ingenus Pharmaceuticals Llc, first approval 12 March 2019Cadila Pharmaceuticals Ltd, first approval 26 March 2019Alkem Laboratories Ltd, first approval 27 March 2019Alembic Pharmaceuticals Ltd, first approval 13 January 2020Aurobindo Pharma Ltd, first approval 24 March 2020Rubicon Research Ltd, first approval 27 May 2020Pharmazone, first approval 13 May 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Apotex Inc3 February 20123
Zydus Pharmaceuticals Usa Inc3 March 20173
Jubilant Generics Ltd4 August 20173
Ingenus Pharmaceuticals Llc12 March 20193
Cadila Pharmaceuticals Ltd26 March 20193
Alkem Laboratories Ltd27 March 20193
Alembic Pharmaceuticals Ltd13 January 20203
Aurobindo Pharma Ltd24 March 20203
Rubicon Research Ltd27 May 20204
Pharmazone13 May 20242

Patents and exclusivities still listed

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

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Zanaflex. 10 generic makers with 22 generic products listed as marketed; the first generic approval is dated 27 June 2002.

19952000200520102015202020252030010brand 1996Dr Reddys Laboratories Inc, first approval 3 July 2002Epic Pharma Llc, first approval 11 October 2002Rising Pharma Holding Inc, first approval 28 March 2003Sun Pharmaceutical Industries Inc, first approval 29 September 2003Tp Anda Holdings Llc, first approval 20 October 2003Aurobindo Pharma Usa Inc, first approval 16 December 2003Apotex Inc, first approval 16 January 2004Unichem Laboratories Ltd, first approval 28 November 2012Cadila Healthcare Ltd, first approval 9 March 2018Alkem Laboratories Ltd, first approval 25 January 2019data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Dr Reddys Laboratories Inc3 July 20022
Epic Pharma Llc11 October 20022
Rising Pharma Holding Inc28 March 20034
Sun Pharmaceutical Industries Inc29 September 20032
Tp Anda Holdings Llc20 October 20032
Aurobindo Pharma Usa Inc16 December 20032
Apotex Inc16 January 20042
Unichem Laboratories Ltd28 November 20122
Cadila Healthcare Ltd9 March 20182
Alkem Laboratories Ltd25 January 20192

Patents and exclusivities still listed

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

Solution, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2024data datePatent 12263158 listed to expire 7 May 2042Patent 12042484 listed to expire 7 May 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 7 May 2042Patent 12263158 drug product
  • 7 May 2042Patent 12042484 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.