cliffwatch

prucalopride succinate · Takeda Pharms Usa · NDA 210166

Motegrity

Earliest generic entry, as listed · earliest of 2 marketed strengths
10 Jul 2028

Blocked by exclusivity: M-14.

FDA has approved 4 generic applications (ANDAs) for Motegrity, though its earliest generic-entry date is 10 Jul 2028 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 · 0 unexpired

No unexpired patents listed.

Exclusivities · 1 unexpired

M-14miscellaneous (3 years)10 Jul 2028

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 approved · 210166-001
  • 25 Oct 2026Generic approved · 210166-001
  • 25 Oct 2026Generic approved · 210166-001
  • 25 Oct 2026Generic approved · 210166-001

Products covered · 2

NDA · productFormStrengthListed expiry
210166 · 001 · RLDtablet, oralEQ 1MG BASE10 Jul 2028
210166 · 002 · RLDtablet, oralEQ 2MG BASE10 Jul 2028