FDA Orange Book · active-ingredient family
Etelcalcetide
Etelcalcetide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PARSABIV · NDA 208325
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PARSABIVRLD×3 | KAI PHARMS INC | NDA 208325 | — | Feb 07, 2017 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9701712 | Jul 29, 2030 | in 4 yr 2 mo | SubstanceProductU-2014 |
| 9278995 | Jul 29, 2030 | in 4 yr 2 mo | Substance |
| 8377880 | Jul 29, 2030 | in 4 yr 2 mo | SubstanceProduct |
| 8999932 | Feb 07, 2031 | in 4 yr 8 mo | SubstanceProductU-2014 |
| 11959486 | Jun 27, 2034 | in 8 yr 2 mo | ProductU-2014 |
| 10344765 | Jun 27, 2034 | in 8 yr 2 mo | Product |
| 11162500 | Jun 27, 2034 | in 8 yr 2 mo | Product |
| 9820938 | Jun 27, 2034 | in 8 yr 2 mo | Product |
Etelcalcetide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
