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OmniRx › Tools › Generic competition check › Linagliptin; Metformin Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Linagliptin; Metformin Hydrochloride, and who makes it?

Linagliptin; Metformin Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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 9.6 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.
Linagliptin; Metformin Hydrochloride2 dosage-form groups in the Orange Book
4generic makers listed
  1. Linagliptin; Metformin Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 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 9.6 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.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Jentadueto. 4 generic makers with 12 generic products listed as marketed; the first generic approval is dated 30 August 2021.

201020152020202520302035204004brand 2012Sunshine Lake Pharma Co Ltd, first approval 30 August 2021Zydus Pharmaceuticals Usa Inc, first approval 30 March 2023Dr Reddys Laboratories Ltd, first approval 3 November 2025Msn Laboratories Private Ltd, first approval 3 November 2025data datePatent 8673927*PED listed to expire 4 November 2027Patent 10022379 listed to expire 2 April 2029Patent 10973827 listed to expire 2 April 2029Patent 9415016 listed to expire 2 April 2029Patent 12678442 listed to expire 2 April 2029Patent 10022379*PED listed to expire 2 October 2029Patent 9415016*PED listed to expire 2 October 2029Patent 10973827*PED listed to expire 2 October 2029Patent 11911388 listed to expire 10 April 2030Patent 9155705 listed to expire 21 May 2030Patent 8846695 listed to expire 4 June 2030Patent 9155705*PED listed to expire 21 November 2030Patent 8846695*PED listed to expire 4 December 2030Patent 12364700 listed to expire 8 June 2037Patent 12364700*PED listed to expire 8 December 2037Exclusivity PED to 20 December 2026
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sunshine Lake Pharma Co Ltd30 August 20213
Zydus Pharmaceuticals Usa Inc30 March 20233
Dr Reddys Laboratories Ltd3 November 20253
Msn Laboratories Private Ltd3 November 20253

Patents and exclusivities still listed

  • 20 December 2026Exclusivity PED Jentadueto
  • 4 November 2027Patent 8673927*PED
  • 2 April 2029Patent 10022379
  • 2 April 2029Patent 10973827 drug product
  • 2 April 2029Patent 9415016 drug product
  • 2 April 2029Patent 12678442 drug product
  • 2 October 2029Patent 10022379*PED
  • 2 October 2029Patent 9415016*PED
  • 2 October 2029Patent 10973827*PED

7 more patents are listed.

Tablet, Extended Release, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Jentadueto Xr. No generic is listed as marketed.

20152020202520302035204001brand 2016data datePatent 9173859*PED listed to expire 4 November 2027Patent 8673927*PED listed to expire 4 November 2027Patent 10022379 listed to expire 2 April 2029Patent 9415016 listed to expire 2 April 2029Patent 12678442 listed to expire 2 April 2029Patent 10022379*PED listed to expire 2 October 2029Patent 9415016*PED listed to expire 2 October 2029Patent 11911388 listed to expire 10 April 2030Patent 9155705 listed to expire 21 May 2030Patent 9155705*PED listed to expire 21 November 2030Patent 9555001 listed to expire 6 March 2033Patent 9555001*PED listed to expire 6 September 2033Patent 12364700 listed to expire 8 June 2037Patent 12364700*PED listed to expire 8 December 2037Exclusivity PED to 20 December 2026
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 December 2026Exclusivity PED Jentadueto Xr
  • 4 November 2027Patent 9173859*PED
  • 4 November 2027Patent 8673927*PED
  • 2 April 2029Patent 10022379
  • 2 April 2029Patent 9415016 drug product
  • 2 April 2029Patent 12678442 drug product
  • 2 October 2029Patent 10022379*PED
  • 2 October 2029Patent 9415016*PED
  • 10 April 2030Patent 11911388

6 more patents are listed.

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.