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.

Listed patents · 30 unexpired

PatentClaimsExpires
US 12213988—1 Oct 2041
US 12409186—1 Oct 2041
US 12213988use U-41401 Apr 2041
US 12409186use U-41401 Apr 2041
US 10973836—9 Sep 2040
US 11903955—9 Sep 2040
US 10973836use U-31279 Mar 2040
US 11903955use U-38259 Mar 2040
US 11826376—18 Jan 2040
US 12472194—18 Jan 2040
US 11826376use U-376618 Jul 2039
US 12472194use U-434618 Jul 2039
US 8685934—26 Nov 2030
US 8721615—18 Jul 2030
US 7919598—16 Jun 2030
US 8685934use U-152226 May 2030
US 7919598substance16 Dec 2029
US 7851502—19 Feb 2029
US 8221786—21 Sep 2028
US 8361972—21 Sep 2028
US 8716251—21 Sep 2028
US 7851502product19 Aug 2028
US 8221786product21 Mar 2028
US 8361972use U-49321 Mar 2028
US 8361972use U-213921 Mar 2028
US 8716251product21 Mar 2028
US 8501698—20 Dec 2027
US 8501698product, use U-49320 Jun 2027
US 8329648—18 Feb 2027
US 8906851—18 Feb 2027

Exclusivities · 3 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

  • 25 Oct 2026Generic tentatively approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026Generic tentatively approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026Generic tentatively approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 25 Oct 2026First generic approved · 202293-001
  • 25 Oct 2026Generic approved · 202293-001
  • 24 Oct 2026Exclusivity expires within 90 days PED · 202293-002
  • 24 Oct 2026Exclusivity expires within 90 days PED · 202293-001

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