cliffwatch

sodium zirconium cyclosilicate · Astrazeneca · NDA 207078

Lokelma

Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Oct 2035

Blocked by patent: US 10300087, US 11738044, US 9592253.

FDA has approved 1 generic application (ANDA) for Lokelma, though its earliest generic-entry date is 14 Oct 2035 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 · 14 unexpired

PatentClaimsExpires
US 10300087drug substance, use U-2312 · sets the listed date14 Oct 2035
US 11738044use U-2312 · sets the listed date14 Oct 2035
US 9592253drug substance, use U-2312 · sets the listed date14 Oct 2035
US 10695365drug substance22 Oct 2033
US 8877255drug substance22 Oct 2033
US 9913860drug substance, use U-231222 Oct 2033
US 8802152drug substance19 Apr 2032
US 10335432use U-231210 Feb 2032
US 10398730use U-231210 Feb 2032
US 10413569drug substance10 Feb 2032
US 11406662drug substance10 Feb 2032
US 8808750use U-231210 Feb 2032
US 9844567use U-231210 Feb 2032
US 9861658use U-231210 Feb 2032

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 217549, Lupin · 207078-001Approved 7 Aug 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 217549, Lupin · 207078-001Approved 7 Aug 2026Detected 25 Oct 2026Historical import

Products covered · 2

NDA · productFormStrengthListed expiry
207078 · 001 · RLDfor suspension, oral5GM/PACKET14 Oct 2035
207078 · 002 · RLDfor suspension, oral10GM/PACKET14 Oct 2035