Prescription medicine
Etelcalcetide Brand names: Parsabiv
Etelcalcetide (Parsabiv) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the etelcalcetide FDA label on DailyMed (effective March 8, 2026, Amgen, Inc); the NDA 208325 record on Drugs@FDA; every etelcalcetide label on DailyMed.
Highlights of the record
FDA label of March 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Forms and strengths
- 2.5 mg/.5ml
- 5 mg/ml
- 10 mg/2ml
Injection (solution).
On the market
- Earliest approval on file
- February 7, 2017 Parsabiv, Kai Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 27, 2034 Parsabiv injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,871 through July 30, 2026
What is etelcalcetide used for?
From the label: indications and usagePARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. […]
FDA pharmacologic class: Calcium-sensing Receptor Agonist.
Source: FDA drug label (PARSABIV), NDA208325 (Kai Pharms Inc), as published by Amgen, Inc, effective March 8, 2026 (SPL set cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c), via openFDA; the full label on DailyMed
Is there a generic for etelcalcetide (Parsabiv)?
No generic etelcalcetide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Parsabiv injection: the compound patent runs to February 7, 2031, and the last listed entry to June 27, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the etelcalcetide label say about other medicines?
The etelcalcetide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cinacalcet | warnings and precautions | Patients switching from cinacalcet to PARSABIV should discontinue cinacalcet for at least 7 days prior to initiating PARSABIV [see Dosage and Administration (2.4) ]. |
Source: FDA drug label (PARSABIV), NDA208325 (Kai Pharms Inc), as published by Amgen, Inc, effective March 8, 2026 (SPL set cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c), via openFDA; the full label on DailyMed
What do FAERS reports show for etelcalcetide?
The FDA Adverse Event Reporting System holds 2,871 reports that list etelcalcetide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 333 are coded as a death and 812 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other calcium-sensing receptor agonists
- the pharmacologic class, with prices and generics
- Etelcalcetide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other