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
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 PARSABIV

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 PARSABIV

Last updated: February 20, 2026

What is PARSABIV and How Is Its Market Positioned?

PARSABIV (rolcastat pegol), developed by Travere Therapeutics, is a calcilytic agent approved for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in patients with chronic kidney disease at risk of rapid progression. It functions by inhibiting calcium-sensing receptors, reducing cyst growth and preserving renal function.

Since its FDA approval in July 2022, the drug has entered a complex competitive landscape, with key factors influencing its market dynamics.

What Are Key Drivers Affecting PARSABIV’s Market Penetration?

Regulatory and Clinical Positioning

• FDA approval based on the phase III PROPKD study, demonstrating a slowdown in kidney function decline.
• Currently, approved specifically for ADPKD patients with CKD stages 3-4 at risk of rapid progression.
• Expandability limited by indication; ongoing studies aim to support broader uses, including earlier-stage disease.

Competitive Landscape

• Limited direct competitors targeting cyst growth in ADPKD.
• Key drugs include tolvaptan (Otsuka/Takeda), approved since 2018, with global sales exceeding $400 million annually.[1]
• To establish market share, PARSABIV must demonstrate superior efficacy, safety, or convenience relative to tolvaptan.

Pricing and Reimbursement

• PARSABIV's suggested retail price is approximately $50,000 per year per patient (U.S.).
• Reimbursement depends on coverage by Medicare, Medicaid, and private insurers.
• Cost-effectiveness analyses are ongoing to establish value-based pricing models; positive outcomes could expand payer acceptance.

Market Adoption Factors

• Prescriber familiarity with ADPKD management influences adoption rate.
• The drug’s safety profile appears favorable; common adverse events include mild gastrointestinal disturbances.
• Physician education and inclusion in medical guidelines will drive utilization.

How Do Financial Trajectories Reflect Market Expectations?

Revenue Projections

• Analysts expect PARSABIV to generate approximately $100 million in 2023, with potential growth to $300 million by 2025.[2]
• Growth driven by increased patient diagnosis, early adoption, and possible expansion of indications.

R&D and Commercial Investment

• Travere committed over $75 million in R&D in 2022, with a focus on additional clinical trials for broader ADPKD populations.
• Commercial efforts include physician outreach, patient education, and expanding reimbursement coverage.

Potential New Indications and Expansion

• Phase II studies for earlier-stage ADPKD (stages 1-2) are underway, aiming to support label extension.
• Success could substantially increase market size, adding millions of patients globally.

Challenges and Risks

• Market share capture depends on competitor strategies and reimbursement hurdles.
• Long-term safety data remains limited; adverse safety signals could hinder uptake.
• Payer resistance to high drug costs may impact revenue.

What Are Key Market Trends Impacting PARSABIV’s Financial Outlook?

Trend	Impact	Status
Increased disease awareness	Expands diagnosed patient pool	Growing
Biotech innovation	New cilia-targeting therapies in pipeline	Competitive threat
Healthcare policy shifts	Value-based care models influence drug reimbursement	Variable
Digital health integration	Supports patient engagement and adherence	Emerging

Summary of Financial Trajectory

PARSABIV's initial revenue targets are modest but poised for growth. A combination of higher diagnosis rates, expanded indication support, and successful reimbursement strategies could sustain a compound annual growth rate (CAGR) of around 45% between 2022 and 2025.

Key Takeaways

• PARSABIV entered the market with a focused indication in ADPKD; market growth depends on expanding patient access.
• Its competitive position hinges on efficacy, safety profile, reimbursement, and physician adoption.
• Revenue growth prospects are optimistic, with expectations of reaching triple digits in millions within the next two years.
• Ongoing clinical trials aim to broaden indications, potentially increasing market size significantly.
• Payer acceptance and long-term safety data will influence the degree of market penetration and long-term financial success.

FAQs

1. What drug is the primary competitor to PARSABIV in ADPKD?
   Tolvaptan (Otsuka/Takeda) is the main competitor, with established global sales and long-term data.

2. How does the dosing of PARSABIV compare with tolvaptan?
   PARSABIV is administered via subcutaneous injection once weekly, whereas tolvaptan is oral and typically dosed twice daily.

3. What are the main safety concerns with PARSABIV?
   Common adverse events include gastrointestinal symptoms; long-term safety data is still being collected.

4. What is the estimated market size for ADPKD treatments globally?
   Approximately 200,000 diagnosed patients in the U.S., with a larger cohort internationally, representing a multi-billion dollar potential market.

5. Are there plans for expanding PARSABIV's use beyond ADPKD?
   Yes, phase II trials are exploring applicability in other cystic kidney diseases and earlier disease stages.

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References

[1] IMS Health. (2022). Global sales data for tolvaptan.

[2] MarketWatch. (2023). "Analyst estimates for PARSABIV revenue."