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-14 | miscellaneous (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
- Generic approved · ANDA 219234, Alembic · 210166-001Approved 27 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219220, Ajanta Pharma Ltd · 210166-001Approved 16 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219180, Micro Labs · 210166-001Approved 29 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219071, Teva Pharms Inc · 210166-001Approved 5 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210166 · 001 · RLD | tablet, oral | EQ 1MG BASE | 10 Jul 2028 |
| 210166 · 002 · RLD | tablet, oral | EQ 2MG BASE | 10 Jul 2028 |