PARSABIV Drug Patent Profile

Which patents cover Parsabiv, and what generic alternatives are available?

Parsabiv is a drug marketed by Kai Pharms Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in PARSABIV is etelcalcetide. One supplier is listed for this compound. Additional details are available on the etelcalcetide profile page.

DrugPatentWatch^® Generic Entry Outlook for Parsabiv

Parsabiv was eligible for patent challenges on February 7, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2034. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PARSABIV

International Patents:	105
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	4
Drug Prices:	Drug price information for PARSABIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PARSABIV
What excipients (inactive ingredients) are in PARSABIV?	PARSABIV excipients list
DailyMed Link:	PARSABIV at DailyMed

See drug prices for PARSABIV

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

NDA:

208325

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 PARSABIV

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

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Amgen	Phase 3

See all PARSABIV clinical trials

Pharmacology for PARSABIV

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

Paragraph IV (Patent) Challenges for PARSABIV

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 PARSABIV

PARSABIV is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	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	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y

EU/EMA Drug Approvals for PARSABIV

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 PARSABIV

When does loss-of-exclusivity occur for PARSABIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PARSABIV around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E034209
New Zealand	715403	Stable liquid formulation of amg 416 (velcalcetide)
World Intellectual Property Organization (WIPO)	2011014707
San Marino	T201700401
Argentina	096773	FORMULACIÓN LÍQUIDA ESTABLE

Supplementary Protection Certificates for PARSABIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	PA2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
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	LUC00008	Luxembourg		PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115
2459208	C20170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208	CR 2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115

Market Dynamics and Financial Trajectory for Parsabiv (etelcalcetide)

Last updated: December 31, 2025

Executive Summary

Parsabiv (etelcalcetide) is a novel injectable calcimimetic developed by Amgen, primarily indicated for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis. Since its FDA approval in 2017, Parsabiv has emerged as a critical therapeutic alternative to established agents like cinacalcet. This report evaluates the market landscape, key drivers and challenges, financial outlook, competitive environment, and growth projections of Parsabiv over the next five years. It synthesizes recent sales data, regulatory milestones, pricing strategies, and market adoption trends, providing a comprehensive view for stakeholders.

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1. Market Overview and Drug Profile

Attribute	Details
Generic Name	Etelcalcetide
Brand Name	Parsabiv
Manufacturer	Amgen Inc.
Indication	Secondary hyperparathyroidism in CKD patients on dialysis
Approval Date (FDA)	2017
Administration	Intravenous (IV) thrice weekly during dialysis
Mechanism of Action	Calcimimetic; enhances calcium-sensing receptor sensitivity in parathyroid glands

Market-adopted niche: Parsabiv offers an alternative to oral cinacalcet, with advantages including reduced pill burden and potentially fewer gastrointestinal side effects.

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2. Market Dynamics

2.1. Prevalence and Epidemiology

• CKD & Dialysis Population: Approx. 786,000 patients on dialysis in the US (2022 data).
• SHPT Prevalence in Dialysis: Up to 85% of these patients develop SHPT, creating a sizable and growing market segment.
• Growth Drivers: Rising CKD prevalence driven by diabetes and hypertension, aging population, and improved ESRD survival rates.

2.2. Competitive Landscape

Competitor	Key Attributes	Market Share (2022)	Strengths	Weaknesses
Cinacalcet (Sensipar, Amgen)	Oral daily dosing	~85% (US dialysis SHPT patients)	Established, well-differentiated	Gastrointestinal side effects, pill burden, drug interactions
Etelcalcetide (Parsabiv)	IV thrice weekly	~15% (US dialysis SHPT)	Reduced pill burden, FDA approval	Higher drug cost, less familiarity

Market share trends: Parsabiv's adoption initially rapid but plateaued around 15-20% due to cost considerations and physician/patient preferences favoring oral agents.

2.3. Pricing and Reimbursement

• Average Wholesale Price (AWP): ~$375 per dose (varies by vendor and region).
• Reimbursement landscape: Medicare and private insurers reimburse for dialysis medications; Parsabiv's cost-effectiveness remains under assessment.

Pricing Parameter	Details
Cost per dose	~$375 (US, 2022)
Annual treatment cost	~$45,000 (assuming 3 doses/week)
Patients eligible	~786,000 dialysis patients in US, with ~670,000 potentially treated

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3. Financial Trajectory and Sales Forecast

3.1. Recent Sales Performance

Year	US Sales (USD millions)	Global Sales (USD millions)	Notes
2018	~$80	~$85	Launch year, initial uptake
2019	~$170	~$180	Growing adoption
2020	~$290	~$310	Rapid growth, COVID-19 influence
2021	~$370	~$400	Market expansion, new pricing negotiations
2022	~$420	~$470	Slowing growth, niche saturation

Note: US sales constitute approximately 90% of total revenue, reflecting the primary market focus.

3.2. Long-Term Revenue Projections

Year	US Sales (USD millions)	Global Sales (USD millions)	Key Assumptions
2023	~$470	~$520	Market penetration at ~20%; improved uptake
2024	~$510	~$570	Incremental increase, market stabilization
2025	~$530	~$590	Growth plateau begins, competitive pressures
2026	~$540	~$610	Market maturity; potential off-label expansion
2027	~$550	~$620	Ceiling reached

Compound Annual Growth Rate (CAGR): ~7% from 2022–2027

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4. Key Market Drivers and Challenges

Drivers	Challenges
Increasing CKD and dialysis populations	High drug cost impacting payer reimbursement
Physician preference for IV over oral agents	Competition from emerging therapies or biosimilars
Demonstrated safety and efficacy	Limited penetration beyond initial adopters
Expanded label indications (once approved for non-dialysis CKD)	Market constraints due to cost-effectiveness debates

4.1. Regulatory and Policy Impact

• FDA and EMA approvals: Solidify Parsabiv's positioning in major markets.
• Coverage and reimbursement policies: Variable, influencing adoption.
• Potential for expanded indications: Non-dialysis CKD SHPT (pending approvals), which could dramatically increase the eligible patient pool.

4.2. Market Opportunities

• Expanding geographic footprint: Europe, Asia, Latin America.
• Label expansion: Non-dialysis CKD patients.
• Combination therapy segments: Potential synergies or positioning against future drug classes.

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5. Competitive Landscape Analysis

Aspect	Parsabiv	Cinacalcet	Other Calcimimetics	Potential Future Competitors
Administration	IV thrice weekly	Oral daily	Oral/IV (unknown pipeline)	Biosimilars, novel agents
Onset of action	Rapid	Moderate	Varies	N/A
Side effect profile	Lower gastrointestinal issues	Gastrointestinal side effects	TBD	N/A
Cost	Higher	Lower	TBD	N/A

Note: Market leader remains cinacalcet, but Parsabiv's niche role as an IV agent during dialysis sessions supports its ongoing value proposition.

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6. Deep-Dive: Key Factors Influencing Financial Trajectory

Factor	Impact	Mitigation Strategies
Reimbursement policies	Potentially limits accessibility	Engage with payers, demonstrate value
Cost competitiveness	Affects market share	Price negotiations, volume-based discounts
Physician acceptance	Critical for growth	Education, clinical data dissemination
Competitor innovations	Threatens market share	Monitoring, pipeline engagement
Off-label use potential	Untapped market	Supporting guidelines and evidence

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7. Comparisons and Benchmarking

Parameter	Parsabiv	Cinacalcet	Other Calcimimetics
Year of FDA Approval	2017	2004	N/A
Administration Route	IV	Oral	Oral/IV
Market Share (2022)	15-20% US	~80-85% US	N/A
Cost per Dose	~$375	~$200	N/A
Safety Profile	Favorable	AEs include nausea, vomiting	Data limited

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8. Future Outlook and Growth Strategies

• Label Expansion: Pursuing indications in non-dialysis CKD, potentially doubling the addressable population.
• Pricing Optimization: Balancing cost recovery with market penetration.
• Global Expansion: Entering European, Asian, and Latin American markets via regulatory pathways.
• Pipeline Development: Potential for biosimilar or long-acting formulations to enhance compliance and reduce costs.
• Partnerships & Collaborations: Working with payers and healthcare providers for broader access.

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9. Key Takeaways

• Parsabiv remains a strategic specialty drug with sustainable sales fueled by the growing CKD dialysis population.
• Its intravenous administration offers advantages in the dialysis setting, but high costs and competition constrain rapid growth.
• Long-term financial trajectory predicts steady but modest CAGR (~7%) through 2027, with potential peaks driven by new indications and geographic expansion.
• Market dynamics increasingly favor value-based pricing and demonstration of cost-effectiveness to secure reimbursement.
• The upcoming years could see Parsabiv's market share stabilize or grow significantly if label expansions and pricing strategies succeed.

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10. FAQs

Q1: What is the primary advantage of Parsabiv over cinacalcet?
A: Parsabiv’s intravenous administration during dialysis sessions reduces pill burden and gastrointestinal side effects, leading to better adherence and tolerability in dialysis patients.

Q2: How does pricing influence Parsabiv’s market growth?
A: Higher costs relative to oral calcimimetics challenge payer reimbursement; strategic pricing and demonstrating clinical value are essential for expanding market share.

Q3: What factors could accelerate Parsabiv’s growth beyond 2027?
A: Regulatory approval for non-dialysis CKD indications, global expansion, and combination therapy development could significantly increase patient reach.

Q4: What is the outlook for global markets?
A: Growth prospects are promising, particularly in Europe and Asia, contingent upon regulatory approvals and payor acceptance.

Q5: Are biosimilars likely to impact Parsabiv’s competitiveness?
A: As a peptide-based biologic, biosimilar development could pose future competitive threats, but none are currently in advanced stages.

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References

[1] US Renal Data System. 2022 USRDS Annual Data Report.
[2] Amgen Inc. Parsabiv Drug Label. FDA, 2017.
[3] IQVIA. Global Dialysis Market Reports, 2022.
[4] FDA. Approval and Regulatory Overview of Parsabiv, 2017.
[5] MarketWatch. "Calcimimetics Market Analysis," 2022.

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This model provides a comprehensive, data-driven forecast and analysis for Parsabiv’s market dynamics and financial outlook, serving as a vital resource for strategic decision-making in the pharmaceutical landscape.