cliffwatch

dapagliflozin · Astrazeneca Ab · NDA 202293

Farxiga

Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Nov 2030

Other strengths are listed to 1 Oct 2041.

Blocked by patent: US 8685934 (pediatric extension).

FDA has approved 15 generic applications (ANDAs) for Farxiga, though its earliest generic-entry date is 26 Nov 2030 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 · 16 unexpired

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

PatentClaimsExpires
US 12213988use U-41401 Oct 2041
US 12213988 listing rowuse U-41401 Apr 2041
US 12213988 listing rowpediatric extension1 Oct 2041
US 12409186use U-41401 Oct 2041
US 12409186 listing rowuse U-41401 Apr 2041
US 12409186 listing rowpediatric extension1 Oct 2041
US 10973836use U-31279 Sep 2040
US 10973836 listing rowuse U-31279 Mar 2040
US 10973836 listing rowpediatric extension9 Sep 2040
US 11903955use U-38259 Sep 2040
US 11903955 listing rowuse U-38259 Mar 2040
US 11903955 listing rowpediatric extension9 Sep 2040
US 11826376use U-376618 Jan 2040
US 11826376 listing rowuse U-376618 Jul 2039
US 11826376 listing rowpediatric extension18 Jan 2040
US 12472194use U-434618 Jan 2040
US 12472194 listing rowuse U-434618 Jul 2039
US 12472194 listing rowpediatric extension18 Jan 2040
US 8685934use U-152226 Nov 2030
US 8685934 listing rowuse U-152226 May 2030
US 8685934 listing rowpediatric extension · sets the listed date26 Nov 2030
US 8721615pediatric extension18 Jul 2030
US 7919598drug substance16 Jun 2030
US 7919598 listing rowdrug substance16 Dec 2029
US 7919598 listing rowpediatric extension16 Jun 2030
US 7851502drug product19 Feb 2029
US 7851502 listing rowdrug product19 Aug 2028
US 7851502 listing rowpediatric extension19 Feb 2029
US 8221786drug product21 Sep 2028
US 8221786 listing rowdrug product21 Mar 2028
US 8221786 listing rowpediatric extension21 Sep 2028
US 8361972use U-2139, U-49321 Sep 2028
US 8361972 listing rowuse U-213921 Mar 2028
US 8361972 listing rowuse U-49321 Mar 2028
US 8361972 listing rowpediatric extension21 Sep 2028
US 8716251drug product21 Sep 2028
US 8716251 listing rowdrug product21 Mar 2028
US 8716251 listing rowpediatric extension21 Sep 2028
US 8501698drug product, use U-49320 Dec 2027
US 8501698 listing rowdrug product, use U-49320 Jun 2027
US 8501698 listing rowpediatric extension20 Dec 2027
US 8329648pediatric extension18 Feb 2027
US 8906851pediatric extension18 Feb 2027

Exclusivities · 2 unexpired

PEDpediatric (6 months added)12 Dec 2027
NPPnew patient population12 Jun 2027
PEDpediatric (6 months added)8 Nov 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

  • Generic tentatively approved · ANDA 219408, Sciegen Pharmaceuticals Inc · 202293-001Tentative approval 1 Oct 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211312, Sandoz · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211312, Sandoz · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211468, Aurobindo Pharma · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211468, Aurobindo Pharma · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211467, Micro Labs · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211467, Micro Labs · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211470, Biocon Pharma · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211470, Biocon Pharma · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic tentatively approved · ANDA 220679, Centaur Pharmaceuticals Private Limited · 202293-001Tentative approval 6 May 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211582, Zydus Pharms · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211582, Zydus Pharms · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211560, Alembic · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211560, Alembic · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211545, Alkem Labs Ltd · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211545, Alkem Labs Ltd · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211541, Teva Pharms Usa · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211541, Teva Pharms Usa · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211535, Cipla · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211535, Cipla · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211531, Lupin · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211531, Lupin · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211523, Aizant · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211523, Aizant · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211156, Inventia · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211156, Inventia · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211506, Macleods Pharms · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211506, Macleods Pharms · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic tentatively approved · ANDA 216119, Jiangsu Hansoh Pharm · 202293-001Tentative approval 2 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211478, Msn · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211478, Msn · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 211482, Ajanta Pharma Ltd · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 211482, Ajanta Pharma Ltd · 202293-001Approved 6 Apr 2026Detected 25 Oct 2026Historical import
  • Exclusivity expires within 90 days PED · 202293-002Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
  • Exclusivity expires within 90 days PED · 202293-001Exclusivity expires 8 Nov 2026Detected 24 Oct 2026

Products covered · 2

NDA · productFormStrengthListed expiry
202293 · 001 · RLDtablet, oral5MG26 Nov 2030
202293 · 002 · RLDtablet, oral10MG1 Oct 2041
Expired or delisted (9)
  • US 8721615 · product · 18 Jan 2030 · delisted
  • US 8329648 · use U-2213 · 18 Aug 2026
  • US 8329648 · use U-2212 · 18 Aug 2026
  • US 8329648 · use U-2139 · 18 Aug 2026
  • US 8906851 · use U-2139 · 18 Aug 2026
  • US 6515117 · — · 4 Apr 2026
  • US 6515117 · substance, product, use U-493 · 4 Oct 2025
  • US 6515117 · substance, product, use U-2139 · 4 Oct 2025
  • M-298 · 8 May 2026