Orange Book product · Brand (NDA)
PARSABIV
ETELCALCETIDE
At a glance
Feb 07, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 07, 2017
9 yr 6 mo ago
Today
Patent 8377880 expires
Listed drug substance patent expiration.
Jul 29, 2030
in 4 yr 2 mo
Patent 9278995 expires
Listed drug substance patent expiration.
Jul 29, 2030
in 4 yr 2 mo
Patent 9701712 expires
Listed drug substance patent expiration.
Jul 29, 2030
in 4 yr 2 mo
Patent 8999932 expires
Listed drug substance patent expiration.
Feb 07, 2031
in 4 yr 8 mo
Patent 10344765 expires
Listed drug product patent expiration.
Jun 27, 2034
in 8 yr 2 mo
Patent 11162500 expires
Listed drug product patent expiration.
Jun 27, 2034
in 8 yr 2 mo
Patent 11959486 expires
Listed drug product patent expiration.
Jun 27, 2034
in 8 yr 2 mo
Patent 9820938 expires
Listed drug product patent expiration.
Jun 27, 2034
in 8 yr 2 mo
Pharmaceutical detail
Active ingredient
ETELCALCETIDE
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208325
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8377880 | Jul 29, 2030 | in 4 yr 2 mo | SubstanceProduct |
| 9278995 | Jul 29, 2030 | in 4 yr 2 mo | Substance |
| 9701712 | Jul 29, 2030 | in 4 yr 2 mo | SubstanceProductU-2014 |
| 8999932 | Feb 07, 2031 | in 4 yr 8 mo | SubstanceProductU-2014 |
| 10344765 | Jun 27, 2034 | in 8 yr 2 mo | Product |
| 11162500 | Jun 27, 2034 | in 8 yr 2 mo | Product |
| 11959486 | Jun 27, 2034 | in 8 yr 2 mo | ProductU-2014 |
| 9820938 | Jun 27, 2034 | in 8 yr 2 mo | Product |
