loperamide hydrochloride · J And J Consumer Inc · NDA 017690, 017694, 019037
Imodium
Earliest generic entry, as listed
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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 · 017694-00130 Sep 2026
- 25 Oct 2026Generic approved · 017694-00129 Dec 2025
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 017690 · 001 · discontinued | capsule, oral | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017694 · 001 · RLD · discontinued | capsule, oral | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019037 · 001 · discontinued | solution, oral | 1MG/5ML | open |