ETELCALCETIDE - Generic Drug Details

What are the generic drug sources for etelcalcetide and what is the scope of patent protection?

Etelcalcetide is the generic ingredient in one branded drug marketed by Kai Pharms Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etelcalcetide has one hundred and five patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for ETELCALCETIDE

International Patents:	105
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	19
Drug Prices:	Drug price trends for ETELCALCETIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ETELCALCETIDE
What excipients (inactive ingredients) are in ETELCALCETIDE?	ETELCALCETIDE excipients list
DailyMed Link:	ETELCALCETIDE at DailyMed

See drug prices for ETELCALCETIDE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ETELCALCETIDE

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ETELCALCETIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Thomas Nickolas, MD MS	Phase 2

See all ETELCALCETIDE clinical trials

Pharmacology for ETELCALCETIDE

Drug Class	Calcium-sensing Receptor Agonist
Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

Anatomical Therapeutic Chemical (ATC) Classes for ETELCALCETIDE

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for ETELCALCETIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PARSABIV	Injection	etelcalcetide	2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL	208325	2	2021-02-08

US Patents and Regulatory Information for ETELCALCETIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes				Y

EU/EMA Drug Approvals for ETELCALCETIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Parsabiv	etelcalcetide	EMEA/H/C/003995Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.	Authorised	no	no	no	2016-11-11

International Patents for ETELCALCETIDE

Country	Patent Number	Title	Estimated Expiration
Slovenia	2459208
Israel	217749	גורמים טיפוליים להורדת רמות הורמון יותרת התריס (Therapeutic agents for reducing parathyroid hormone levels)
Singapore	11201510647T
Spain	2633989
Jordan	3817	تركيبة سائلة مستقرة ل " AMG 416 " (فيلكالسيتيد) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE))

Supplementary Protection Certificates for ETELCALCETIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	654	Finland
2459208	1790012-7	Sweden		PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	PA2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	17C1009	France		PRODUCT NAME: ETELCALCETIDE, OU UN SEL DE CELUI-CI, NOTAMMENT LE CHLORHYDRATE D'ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208	2017021	Norway		PRODUCT NAME: ETELKALSETID, ELLER ET SALT DERAV, INKLUDERT ETELKALSETIDHYDROKLORID; NAT. REG. NO/DATE: EU/1/16/1142 20161122; FIRST REG. NO/DATE: EU/1/16/1142/001-012 20161115

Market Dynamics and Financial Trajectory for Eltelcalcetide

Last updated: February 20, 2026

What is the current market landscape for etelcalcetide?

Eltelcalcetide is a calcimimetic agent marketed primarily for secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients undergoing hemodialysis. Its primary competitor is cinacalcet (Sensipar). The drug gained FDA approval in December 2016 and was subsequently approved by the European Medicines Agency (EMA) in 2017.

Market size estimates for this segment are driven by the global prevalence of CKD, which affects approximately 700 million people worldwide. Of these, about 40% progress to end-stage kidney disease (ESKD) requiring dialysis, the primary market for etelcalcetide.

How does etelcalcetide perform clinically relative to competitors?

Clinical trials demonstrate that etelcalcetide effectively reduces parathyroid hormone (PTH) levels in dialysis patients. Its administration is via intravenous injection three times weekly, aligning with dialysis sessions, which improves adherence compared to oral agents like cinacalcet. Patients indicated higher tolerability, especially with fewer gastrointestinal side effects.

What are the key regulatory and commercial milestones?

Regulatory approvals:

• FDA: Approved December 2016
• EMA: Approved October 2017
• Japan: Approved in 2018

Commercialization:

• Market entry by Amgen Inc., which owns rights to etelcalcetide.
• Commercial sales commenced in the U.S. and Europe immediately post-approval.

How does the market share look?

Amgen dominates the etelcalcetide market, leveraging its global distribution network. The drug's market share is estimated at over 60% within its therapeutic segment. Cinacalcet remains a competitor due to its longer market presence and oral administration route, which remains favorable in some regions.

Sales data (2018-2022):

Year	Global Sales (USD millions)	Growth Rate
2018	120	N/A
2019	180	50%
2020	230	28%
2021	290	26%
2022	330	14%

Market penetration was slower initially but accelerated after formulary acceptance in major dialysis providers.

What factors influence future financial trajectory?

Market expansion:

• Increasing CKD prevalence, especially in Asia-Pacific.
• Growing dialysis patient population worldwide.

Pricing:

• Average wholesale price (AWP) around USD 300 per dose.
• Reimbursement policies vary by country, influencing net revenue.

Competition:

• Generic development of calcimimetics could pressure prices.
• Potential entry of new drugs or biosimilars.

R&D pipeline:

• Amgen and other players are developing next-generation calcimimetics.
• Companion diagnostics for personalized treatment could shift spending.

Regulatory landscape:

• Expanding indications can provide revenue lift.
• Price negotiations and formulary placements influence realized sales.

What are the risk factors impacting revenue forecasts?

• Slower adoption rates in emerging markets.
• Competitive pricing pressures.
• Healthcare policy shifts reducing dialysis coverage.
• Delays in approval or data readouts for new indications.

How does the financial outlook compare with other calcimimetics?

Drug	Approval Year	Market Share (2022)	Annual Sales (USD millions)	Route of Administration
Etelcalcetide	2016	60%+	330	Intravenous (3x/week)
Cinacalcet (Sensipar)	2004	40%	720	Oral

Despite lower absolute sales, etelcalcetide's growth rate exceeds that of cinacalcet, driven by its compliance benefits.

Key Takeaways

• The global CKD treatment market for calcimimetics is growing, driven by rising dialysis populations.
• Amgen’s etelcalcetide holds a significant market share, with growth fueled by clinical benefits and dialysis-compatible dosing.
• Financial success hinges on market expansion, pricing strategies, and the competitive landscape.
• Ongoing R&D and expanding indications could drive future revenue increases.
• Pricing and reimbursement policies significantly influence earnings potential.

FAQs

1. What is the primary advantage of etelcalcetide over cinacalcet?
Intravenous administration timed with dialysis sessions offers improved adherence and fewer gastrointestinal side effects.

2. How does CKD prevalence affect etelcalcetide sales?
Higher CKD and dialysis rates expand the potential patient base, increasing sales prospects.

3. What regions are key to etelcalcetide’s growth?
North America and Europe are current markets; Asia-Pacific represents a major future growth opportunity due to rising CKD prevalence.

4. What pricing strategies impact revenue?
Pricing varies with healthcare systems; price consistency and reimbursement rates critically affect net sales.

5. What risks threaten future revenue growth?
Competitive pressures from biosimilars, regulatory delays, and policy shifts could limit growth.

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References

[1] National Kidney Foundation. (2022). CKD prevalence and epidemiology.
[2] Amgen Inc. Annual Reports (2016-2022).
[3] European Medicines Agency. (2017). Approval summaries for etelcalcetide.
[4] U.S. Food and Drug Administration. (2016). Approval decision documentation.
[5] Market data reports from IQVIA. (2022).