cliffwatch

difelikefalin acetate · Vifor Intl · NDA 214916

Korsuva

Earliest generic entry, as listed
12 Nov 2032

Blocked by patent: US 7402564.

FDA has approved 1 generic application (ANDA) for Korsuva, though its earliest generic-entry date is 12 Nov 2032 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 · 12 unexpired

PatentClaimsExpires
US 7402564drug substance, drug product, use U-3204 · sets the listed date12 Nov 2032
US 10017536drug substance, use U-320412 Nov 2027
US 10138270use U-320412 Nov 2027
US 10793596drug substance, drug product, use U-320412 Nov 2027
US 7713937drug substance, drug product, use U-320412 Nov 2027
US 7727963drug substance, drug product, use U-320412 Nov 2027
US 8217007use U-320412 Nov 2027
US 8236766use U-320412 Nov 2027
US 8486894use U-320412 Nov 2027
US 8536131drug substance, drug product, use U-320412 Nov 2027
US 9334305use U-320412 Nov 2027
US 9359399use U-320412 Nov 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

  • First generic approved · ANDA 220919, Qilu Pharm Hainan · 214916-001Approved 31 Aug 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 220919, Qilu Pharm Hainan · 214916-001Approved 31 Aug 2026Detected 25 Oct 2026Historical import

Products covered · 1

NDA · productFormStrengthListed expiry
214916 · 001 · RLDsolution, intravenousEQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)12 Nov 2032
Expired or delisted (1)
  • NCE · 23 Aug 2026