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OmniRx › Tools › Generic competition check › Tapentadol Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Tapentadol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 13.3 and 17.2 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.
Tapentadol Hydrochloride3 dosage-form groups in the Orange Book
3generic makers listed
  1. Tapentadol Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 3 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 13.3 and 17.2 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, Oral

One to three generic makers listed

Brand listed as marketed: Nucynta. 2 generic makers with 6 generic products listed as marketed; the first generic approval is dated 27 January 2026.

20052010201520202025203002brand 2008Epic Pharma Llc, first approval 27 January 2026Msn Laboratories Private Ltd, first approval 3 September 2026data dateExclusivity PED to 3 January 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Epic Pharma Llc27 January 20263
Msn Laboratories Private Ltd3 September 20263

Patents and exclusivities still listed

  • 3 January 2027Exclusivity PED Nucynta

Tablet, Extended Release, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Nucynta Er. No generic is listed as marketed.

2010201520202025203001brand 2011data datePatent 11344512 listed to expire 21 April 2028Patent 8536130 listed to expire 22 September 2028Patent 11344512*PED listed to expire 21 October 2028Patent 8536130*PED listed to expire 22 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 April 2028Patent 11344512
  • 22 September 2028Patent 8536130
  • 21 October 2028Patent 11344512*PED
  • 22 March 2029Patent 8536130*PED

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 January 2026.

2010201520202025203001brand 2012Novitium Pharma Llc, first approval 26 January 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Novitium Pharma Llc26 January 20261

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.