cliffwatch

empagliflozin · Boehringer Ingelheim · NDA 204629

Jardiance

Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Dec 2034

Blocked by patent: US 9949998 (pediatric extension).

FDA has approved 1 generic application (ANDA) for Jardiance, though its earliest generic-entry date is 11 Dec 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 15 unexpired

35 Orange Book listing rows for 15 patents, including 12 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 9949998use U-229011 Dec 2034
US 9949998 listing rowuse U-229011 Jun 2034
US 9949998 listing rowpediatric extension · sets the listed date11 Dec 2034
US 9949997use U-2292, U-3199, U-332517 Nov 2034
US 9949997 listing rowuse U-229217 May 2034
US 9949997 listing rowuse U-319917 May 2034
US 9949997 listing rowuse U-332517 May 2034
US 9949997 listing rowpediatric extension17 Nov 2034
US 10258637use U-22903 Oct 2034
US 10258637 listing rowuse U-22903 Apr 2034
US 10258637 listing rowpediatric extension3 Oct 2034
US 11090323use U-31913 Oct 2034
US 11090323 listing rowuse U-31913 Apr 2034
US 11090323 listing rowpediatric extension3 Oct 2034
US 11813275use U-3759, U-37603 Oct 2034
US 11813275 listing rowuse U-37593 Apr 2034
US 11813275 listing rowuse U-37603 Apr 2034
US 11813275 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 12433906use U-4293, U-4294, U-4295, U-4296, U-43043 Oct 2034
US 12433906 listing rowuse U-42933 Apr 2034
US 12433906 listing rowuse U-42943 Apr 2034
US 12433906 listing rowuse U-42953 Apr 2034
US 12433906 listing rowuse U-42963 Apr 2034
US 12433906 listing rowuse U-43043 Apr 2034
US 12433906 listing rowpediatric extension3 Oct 2034
US 11666590use U-36913 Apr 2034
US 12263153use U-41713 Apr 2034
US 12427162use U-42873 Apr 2034
US 12527810use U-440322 Oct 2033
US 12527810 listing rowuse U-440322 Apr 2033
US 12527810 listing rowpediatric extension22 Oct 2033
US 12115179use U-402311 Aug 2030
US 12115179 listing rowuse U-402311 Feb 2030
US 12115179 listing rowpediatric extension11 Aug 2030
US 8551957use U-165114 Apr 2030
US 8551957 listing rowuse U-165114 Oct 2029
US 8551957 listing rowpediatric extension14 Apr 2030
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 · 1 unexpired

PEDpediatric (6 months added)20 Dec 2026

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 · 204629-001
  • 25 Oct 2026Generic approved · 204629-001
  • 24 Oct 2026Exclusivity expires within 90 days PED · 204629-002
  • 24 Oct 2026Exclusivity expires within 90 days PED · 204629-001

Products covered · 2

NDA · productFormStrengthListed expiry
204629 · 001 · RLDtablet, oral10MG11 Dec 2034
204629 · 002 · RLDtablet, oral25MG11 Dec 2034
Expired or delisted (2)
  • I-922 · 21 Sep 2026
  • NPP · 20 Jun 2026