metoclopramide hydrochloride · Ani Pharms · NDA 017854, 017862, 018821
Reglan
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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
- 25 Oct 2026Generic approved · 017862-00111 Sep 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 017854 · 001 · RLD | tablet, oral | EQ 10MG BASE | open |
| 017854 · 002 · RLD | tablet, oral | EQ 5MG BASE | open |
| 017862 · 001 · RLD · discontinued | injectable, injection | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017862 · 004 · discontinued | injectable, injection | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018821 · 001 · RLD · discontinued | solution, oral | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |