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 (pediatric extension).

Listed patents · 16 unexpired

28 Orange Book listing rows for 16 patents, including 10 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12364700use U-42248 Dec 2037
US 12364700 listing rowuse U-42248 Jun 2037
US 12364700 listing rowpediatric extension · sets the listed date8 Dec 2037
US 9949998use U-273111 Dec 2034
US 9949998 listing rowuse U-273111 Jun 2034
US 9949998 listing rowpediatric extension11 Dec 2034
US 10258637use U-27313 Oct 2034
US 10258637 listing rowuse U-27313 Apr 2034
US 10258637 listing rowpediatric extension3 Oct 2034
US 11090323use U-31923 Oct 2034
US 11090323 listing rowuse U-31923 Apr 2034
US 11090323 listing rowpediatric extension3 Oct 2034
US 11833166use U-3776, U-37773 Oct 2034
US 11833166 listing rowuse U-37763 Apr 2034
US 11833166 listing rowuse U-37773 Apr 2034
US 11833166 listing rowpediatric extension3 Oct 2034
US 10596120drug product, use U-2776, U-27907 Mar 2032
US 10596120 listing rowdrug product, use U-27767 Mar 2032
US 10596120 listing rowdrug product, use U-27907 Mar 2032
US 11564886drug product, use U-35317 Mar 2032
US 12115179use U-402311 Aug 2030
US 12115179 listing rowuse U-402311 Feb 2030
US 12115179 listing rowpediatric extension11 Aug 2030
US 10406172drug product, use U-273315 Jun 2030
US 9155705drug product21 May 2030
US 8551957drug product, use U-273014 Apr 2030
US 8551957 listing rowdrug product, use U-273014 Oct 2029
US 8551957 listing rowpediatric extension14 Apr 2030
US 12678442drug product2 Oct 2029
US 12678442 listing rowdrug product2 Apr 2029
US 12678442 listing rowpediatric extension2 Oct 2029
US 10022379drug product, use U-27322 Apr 2029
US 9415016drug product2 Apr 2029
US 7579449drug substance1 Feb 2029
US 7579449 listing rowdrug substance1 Aug 2028
US 7579449 listing rowpediatric extension1 Feb 2029
US 7713938drug substance, drug product15 Oct 2027
US 7713938 listing rowdrug substance, drug product15 Apr 2027
US 7713938 listing rowpediatric extension15 Oct 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

  • Generic tentatively approved · ANDA 217049, Zydus Pharms Usa Inc · 212614-001Tentative approval 25 Nov 2025Detected 25 Oct 2026Historical import

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