amiodarone hydrochloride · Baxter Hlthcare · NDA 022325
Nexterone
Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Feb 2033
Blocked by patent: US 9493582.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9493582 | product | 27 Feb 2033 |
| US 10117951 | product | 13 Mar 2029 |
| US 7635773 | product | 13 Mar 2029 |
| US 8410077 | product | 13 Mar 2029 |
| US 9200088 | product | 13 Mar 2029 |
| US 9750822 | product | 13 Mar 2029 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022325 · 001 · RLD · discontinued | injectable, injection | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 13 Mar 2029 |
| 022325 · 002 · RLD | injectable, injection | 150MG/100ML (1.5MG/ML) | 27 Feb 2033 |
| 022325 · 003 · RLD | injectable, injection | 360MG/200ML (1.8MG/ML) | 27 Feb 2033 |