etelcalcetide · Kai Pharms Inc · NDA 208325
Parsabiv
Earliest generic entry, as listed · earliest of 3 marketed strengths
27 Jun 2034
Blocked by patent: US 10344765, US 11162500, US 11959486, US 9820938.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10344765 | drug product · sets the listed date | 27 Jun 2034 |
| US 11162500 | drug product · sets the listed date | 27 Jun 2034 |
| US 11959486 | drug product, use U-2014 · sets the listed date | 27 Jun 2034 |
| US 9820938 | drug product · sets the listed date | 27 Jun 2034 |
| US 8999932 | drug substance, drug product, use U-2014 | 7 Feb 2031 |
| US 8377880 | drug substance, drug product | 29 Jul 2030 |
| US 9278995 | drug substance | 29 Jul 2030 |
| US 9701712 | drug substance, drug product, use U-2014 | 29 Jul 2030 |
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 |
|---|---|---|---|
| 208325 · 001 · RLD | solution, intravenous | 2.5MG/0.5ML (2.5MG/0.5ML) | 27 Jun 2034 |
| 208325 · 002 · RLD | solution, intravenous | 5MG/ML (5MG/ML) | 27 Jun 2034 |
| 208325 · 003 · RLD | solution, intravenous | 10MG/2ML (5MG/ML) | 27 Jun 2034 |