Generic competition · all medicines · read 12 November 2026
Is there a generic of Empagliflozin; Metformin Hydrochloride, and who makes it?
Empagliflozin; Metformin Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 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 6.9 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.
- Empagliflozin; Metformin Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
- 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 6.9 years after the first brand approval.
- 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
Brand listed, no generic listed as marketed
Brand listed as marketed: Synjardy. No generic is listed as marketed (4 generic products listed as discontinued).
Patents and exclusivities still listed
- 20 December 2026Exclusivity PED Synjardy
- 15 April 2027Patent 7713938 drug substance
- 15 October 2027Patent 7713938*PED
- 1 August 2028Patent 7579449 drug substance
- 1 February 2029Patent 7579449*PED
- 11 February 2030Patent 12115179
- 11 August 2030Patent 12115179*PED
- 30 September 2030Patent 10610489 drug product
- 30 March 2031Patent 10610489*PED
17 more patents are listed.
Tablet, Extended Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Synjardy Xr. No generic is listed as marketed.
Patents and exclusivities still listed
- 20 December 2026Exclusivity PED Synjardy Xr
- 15 April 2027Patent 7713938 drug substance
- 15 October 2027Patent 7713938*PED
- 1 August 2028Patent 7579449 drug substance
- 1 February 2029Patent 7579449*PED
- 11 February 2030Patent 12115179
- 11 August 2030Patent 12115179*PED
- 7 March 2032Patent 10596120 drug product
- 7 September 2032Patent 10596120*PED
17 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.