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

Constraining patent/regulatory exclusivity:

10,344,765

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	9,701,712		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	9,278,995			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	9,701,712		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	11,959,486		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	10,344,765		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	10,344,765		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	9,820,938		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
Portugal	3192520
Malaysia	180276
Japan	2013500990
European Patent Office	3539555	AGENTS THÉRAPEUTIQUES DE RÉDUCTION DES NIVEAUX D'HORMONE PARATHYROÏDE (THERAPEUTIC AGENTS FOR REDUCING PARATHYROID HORMONE LEVELS)
European Patent Office	3246017
Poland	3013318
European Patent Office	3878433

Supplementary Protection Certificates for ETELCALCETIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	2017/011	Ireland		PRODUCT NAME: ETELCALCETIDE, OR A SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161111
2459208	C02459208/01	Switzerland		PRODUCT NAME: ETELCALCETID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66338 27.09.2017
2459208	122017000021	Germany		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	C20170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208	PA2017007,C2459208	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	387 50003-2017	Slovakia		PRODUCT NAME: ETELKALCETID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1142/001 - EU/1/16/1142/012 20161115
2459208	132017000041085	Italy		PRODUCT NAME: ETELCALCETIDE, O UN SUO SALE, COMPRESO ETELCALCETIDE IDROCLORURO(PARSABIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1142/001-012, 20161115

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Etelcalcetide

Last updated: July 28, 2025

Introduction

Etelcalcetide, marketed under the brand name Parsabiv®, is a novel calcimimetic agent approved by the U.S. Food and Drug Administration (FDA) in 2017 for managing secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. Its unique mechanism and targeted application position it as a significant player within the nephrology therapeutic landscape. This article provides a comprehensive analysis of etelcalcetide’s market dynamics, including competitive landscape, regulatory factors, pricing strategies, and financial trajectory, with insights into future growth prospects.

Pharmacological Profile and Clinical Positioning

Etelcalcetide functions by activating calcium-sensing receptors (CaSR) on the parathyroid gland, suppressing parathyroid hormone (PTH) secretion more effectively than traditional vitamin D analogs. Its subcutaneous administration aligns with dialysis sessions, enhancing patient compliance compared to oral calcimimetics like cinacalcet. The drug’s efficacy in reducing PTH levels and minimizing hypercalcemia has been a critical clinical advantage, fostering adoption among nephrologists for managing SHPT.

Market Drivers

1. Rising CKD and Dialysis Prevalence

The global burden of CKD, particularly in developed countries, fuels demand for SHPT therapeutics. The U.S. Renal Data System (USRDS) reports over 786,000 patients on dialysis, with SHPT affecting a significant majority. The increasing prevalence correlates with aging populations, rising diabetes and hypertension rates, and improved dialysis access, all underpinning sustained demand for etelcalcetide.

2. Therapeutic Advantages and Improved Adherence

Compared to oral calcimimetics, etelcalcetide’s intravenous route administered during dialysis sessions improves adherence and consistency of PTH management. This convenience factor incentivizes nephrologists to prefer etelcalcetide, especially in patients exhibiting poor compliance with oral medications.

3. Regulatory and Reimbursement Environment

Regulatory approval in major markets, combined with favorable reimbursement policies, has facilitated market entry. In the U.S., Medicare and private insurers cover dialysis treatments extensively, including SHPT medications, creating a stable revenue environment.

Competitive Landscape

Key Players

• Amgen Inc.: The sole manufacturer of etelcalcetide (Parsabiv®), holding a dominant market share. Its established position is due to first-mover advantage, extensive clinical data, and integrated dialysis program reach.
• Cinacalcet (Sensipar®, marketed by Amgen): The oral calcimimetic competitor with wider global sales, though less adherence-friendly.
• Emerging Agents: Several pipeline drugs and biosimilars aim to challenge or complement existing therapies, though none currently surpass etelcalcetide’s clinical positioning.

Market Penetration

Amgen’s strategic focus on expanding dialysis centers’ adoption, including collaborations with healthcare providers and nephrology networks, has driven steady penetration. However, competition from generics and biosimilars could impact market share long-term.

Pricing Strategy and Reimbursement

Etelcalcetide’s pricing reflects its targeted niche, with costs aligned to dialysis treatment sessions. The drug’s per-dose cost is approximately $110–$130, comparable to the costs associated with competing therapies. Reimbursement rates through Medicare and private insurers support consistent revenue streams for providers and manufacturers.

Regulatory and Market Challenges

Regulatory Approvals

Beyond the U.S., etelcalcetide’s approval in Europe and other territories remains pending or limited, constraining global market growth. Variability in regulatory requirements and clinical trial data interpretations influence approval timelines.

Safety and Efficacy Perceptions

While proven effective, concerns regarding hypocalcemia and other adverse effects necessitate vigilant monitoring. These safety considerations sometimes restrict utilization to specialized centers, impacting broad adoption.

Market Saturation and Patent Expiry Risks

Amgen’s patent protections extend into the late 2020s; however, biosimilar development threatens future pricing and market share, especially in the European Union and emerging markets.

Financial Trajectory and Revenue Outlook

Current Revenue Generation

Since its launch, etelcalcetide has demonstrated steady revenue growth. In 2022, Amgen reported approximately $380 million in global sales, with the U.S. accounting for the bulk. Strong uptake is driven by clinical efficacy data and dialysis integration.

Forecasts and Future Growth

Analysts project a compounded annual growth rate (CAGR) of 6–8% over the next five years, driven by:

• Expanding Dialysis Patient Base: Projections indicate a continued increase in dialysis prevalence, especially in Asia-Pacific and Latin America.
• Market Penetration Expansion: As awareness grows and more dialysis centers adopt etelcalcetide, sales are expected to rise.
• Pipeline and Line Extensions: Potential new indications or formulations could extend product lifecycle.

However, reimbursement pressures, biosimilar entry, and safety profile considerations may temper growth projections.

Market Challenges and Opportunities

Challenges

• Global Regulatory Delays: Limited approvals outside the U.S. hamper revenue diversification.
• Competitive Biosimilars: The potential emergence of biosimilars post-patent expiry could erode market share.
• Market Saturation: Mature markets approach saturation, demanding strategies for penetration into emerging markets.

Opportunities

• Expansion into Peritoneal Dialysis and Non-Dialysis CKD Settings: Exploring additional indications may diversify revenue streams.
• Combination Therapies: Developing combined formulations with other CKD medications could enhance clinical outcomes.
• Emerging Markets: Demographic shifts and increasing dialysis infrastructure in Asia present growth avenues.

Conclusion

Etelcalcetide’s market dynamics are shaped by its clinical advantages, a growing dialysis population, and strategic positioning within nephrology. While its current financial trajectory demonstrates robust growth driven by high efficacy and adherence benefits, competition, regulatory hurdles, and patent expiries pose future challenges. Ongoing market expansion, pipeline development, and potential regulatory approvals outside the U.S. will be critical to sustaining and enhancing its financial performance.

Key Takeaways

• Etelcalcetide has established a strong foothold in the SHPT treatment market, primarily within the U.S. dialysis setting.
• The drug benefits from its intravenous delivery, improving adherence over oral alternatives, which drives clinical and financial adoption.
• Market growth is contingent on expanding geographic approvals, overcoming biosimilar competition, and penetrating emerging markets.
• Revenues are projected to grow modestly but steadily, with potential for acceleration through pipeline extensions and strategic partnerships.
• Monitoring regulatory landscapes and biosimilar developments remains essential for anticipating market shifts and long-term profitability.

FAQs

1. What factors influence the pricing of etelcalcetide?
Pricing is influenced by the drug’s targeted use during dialysis sessions, manufacturer’s strategy, reimbursement frameworks, and comparative costs with existing therapies such as cinacalcet.

2. How does etelcalcetide compare to other calcimimetics?
Compared to oral calcimimetics like cinacalcet, etelcalcetide offers improved adherence due to its intravenous route, with comparable or superior efficacy in controlling PTH levels.

3. What are the main regulatory hurdles for etelcalcetide’s global expansion?
Regulatory challenges include differing clinical data requirements, safety profile assessments, and varying standards for biosimilar approvals across regions like Europe, Asia, and others.

4. How significant are biosimilar risks to etelcalcetide’s future revenues?
Post-patent expiration, biosimilar development poses a significant risk, potentially leading to reduced prices and market share, especially in cost-sensitive markets.

5. What growth strategies can Amgen pursue for etelcalcetide?
Strategies include seeking approval in additional markets, exploring new indications, investing in pipeline innovations, and forming collaborations to improve access in emerging regions.

---

Sources

[1] U.S. Food and Drug Administration (FDA). Parsabiv (etelcalcetide) prescribing information. 2017.
[2] USRDS Annual Data Report. 2022.
[3] Amgen Inc. Financial Reports and Investor Presentations. 2022.
[4] MarketResearch.com, "Global Calcimimetics Market Analysis," 2022.
[5] European Medicines Agency (EMA). Regulatory status of etelcalcetide in Europe. 2023.