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OmniRx › Tools › Generic competition check › Tramadol Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Tramadol Hydrochloride appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 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 4.2 and 7.3 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.
Tramadol Hydrochloride5 dosage-form groups in the Orange Book
13generic makers listed
  1. Tramadol Hydrochloride appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 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 4.2 and 7.3 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.

Tablet, Extended Release, Oral

One to three generic makers listed

Every brand product here is listed as discontinued. 2 generic makers with 6 generic products listed as marketed; the first generic approval is dated 13 November 2009.

20052010201520202025203002brand 2005Lupin Ltd, first approval 29 August 2011Macleods Pharmaceuticals Ltd, first approval 31 January 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Lupin Ltd29 August 20113
Macleods Pharmaceuticals Ltd31 January 20253

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

Every brand product here is listed as discontinued. 10 generic makers with 16 generic products listed as marketed; the first generic approval is dated 19 June 2002.

19952000200520102015202020252030010brand 1995Sun Pharmaceutical Industries Inc, first approval 19 June 2002Teva Pharmaceuticals Usa Inc, first approval 19 June 2002Amneal Pharmaceuticals Of New York Llc, first approval 20 June 2002Graviti Pharmaceuticals Private Ltd, first approval 25 June 2002Pharmazone, first approval 31 January 2011Strides Pharma Global Pte Ltd, first approval 28 November 2011Cspc Ouyi Pharmaceutical Co Ltd, first approval 29 March 2013Aurobindo Pharma Ltd, first approval 31 March 2014Rubicon Research Ltd, first approval 28 June 2019Unichem Laboratories Ltd, first approval 9 August 2019data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sun Pharmaceutical Industries Inc19 June 20021
Teva Pharmaceuticals Usa Inc19 June 20021
Amneal Pharmaceuticals Of New York Llc20 June 20021
Graviti Pharmaceuticals Private Ltd25 June 20023
Pharmazone31 January 20111
Strides Pharma Global Pte Ltd28 November 20112
Cspc Ouyi Pharmaceutical Co Ltd29 March 20131
Aurobindo Pharma Ltd31 March 20141
Rubicon Research Ltd28 June 20194
Unichem Laboratories Ltd9 August 20191

Patents and exclusivities still listed

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

Capsule, Extended Release, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2010data 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.

Solution, Oral

One to three generic makers listed

Every brand product here is listed as discontinued. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 26 June 2026.

20202025203001brand 2020Novitium Pharma Llc, first approval 26 June 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Novitium Pharma Llc26 June 20261

Patents and exclusivities still listed

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

Tablet, Orally Disintegrating, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

20052010201520202025203001brand 2005data 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.