ropivacaine hydrochloride · Fresenius Kabi Usa · NDA 020533
Naropin
Earliest generic entry, as listed · earliest of 11 marketed strengths
28 Nov 2026
9 of 11 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 7857802.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7857802 | product | 28 Nov 2026 |
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
- 24 Oct 2026Enters 12-month window basis: patent · 020533-00728 Nov 2026
- 24 Oct 2026Enters 12-month window basis: patent · 020533-00628 Nov 2026
Products covered · 13
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020533 · 001 · RLD | solution, injection | 20MG/10ML (2MG/ML) | open |
| 020533 · 002 · RLD | solution, injection | 40MG/20ML (2MG/ML) | open |
| 020533 · 003 · RLD | solution, injection | 100MG/20ML (5MG/ML) | open |
| 020533 · 004 · RLD | solution, injection | 150MG/20ML (7.5MG/ML) | open |
| 020533 · 005 · RLD | solution, injection | 100MG/10ML (10MG/ML) | open |
| 020533 · 006 · RLD | solution, injection | 200MG/100ML (2MG/ML) | 28 Nov 2026 |
| 020533 · 007 · RLD | solution, injection | 400MG/200ML (2MG/ML) | 28 Nov 2026 |
| 020533 · 008 · RLD | solution, injection | 150MG/30ML (5MG/ML) | open |
| 020533 · 009 · RLD | solution, injection | 500MG/100ML (5MG/ML) | open |
| 020533 · 010 · RLD | solution, injection | 1GM/200ML (5MG/ML) | open |
| 020533 · 011 · RLD | solution, injection | 200MG/20ML (10MG/ML) | open |
| 020533 · 012 · RLD · discontinued | solution, injection | 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020533 · 013 · RLD · discontinued | solution, injection | 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |