cliffwatch

empagliflozin; linagliptin; metformin hydrochloride · Boehringer Ingelheim · NDA 212614

Trijardy Xr

Earliest generic entry, as listed · earliest of 4 marketed strengths
8 Dec 2037

Blocked by patent: US 12364700.

Listed patents · 28 unexpired

PatentClaimsExpires
US 12364700—8 Dec 2037
US 12364700use U-42248 Jun 2037
US 9949998—11 Dec 2034
US 10258637—3 Oct 2034
US 11090323—3 Oct 2034
US 11833166—3 Oct 2034
US 9949998use U-273111 Jun 2034
US 10258637use U-27313 Apr 2034
US 11090323use U-31923 Apr 2034
US 11833166use U-37763 Apr 2034
US 11833166use U-37773 Apr 2034
US 10596120product, use U-27767 Mar 2032
US 10596120product, use U-27907 Mar 2032
US 11564886product, use U-35317 Mar 2032
US 12115179—11 Aug 2030
US 10406172product, use U-273315 Jun 2030
US 9155705product21 May 2030
US 8551957—14 Apr 2030
US 12115179use U-402311 Feb 2030
US 8551957product, use U-273014 Oct 2029
US 12678442—2 Oct 2029
US 10022379product, use U-27322 Apr 2029
US 12678442product2 Apr 2029
US 9415016product2 Apr 2029
US 7579449—1 Feb 2029
US 7579449substance1 Aug 2028
US 7713938—15 Oct 2027
US 7713938substance, product15 Apr 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic tentatively approved · 212614-001

Products covered · 4

NDA · productFormStrengthListed expiry
212614 · 001 · RLDtablet, extended release, oral5MG;2.5MG;1GM8 Dec 2037
212614 · 002 · RLDtablet, extended release, oral10MG;5MG;1GM8 Dec 2037
212614 · 003 · RLDtablet, extended release, oral12.5MG;2.5MG;1GM8 Dec 2037
212614 · 004 · RLDtablet, extended release, oral25MG;5MG;1GM8 Dec 2037
Expired or delisted (2)
  • US 8883805 · — · 26 May 2026
  • US 8883805 · product · 26 Nov 2025