clonazepam · Roche · NDA 020813
Klonopin Rapidly Disintegrating
Earliest generic entry, as listed · earliest of 5 marketed strengths
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 · 020813-00121 May 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020813 · 001 · RLD · discontinued | tablet, orally disintegrating, oral | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020813 · 002 · RLD · discontinued | tablet, orally disintegrating, oral | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020813 · 003 · RLD · discontinued | tablet, orally disintegrating, oral | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020813 · 004 · RLD · discontinued | tablet, orally disintegrating, oral | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020813 · 005 · RLD · discontinued | tablet, orally disintegrating, oral | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |