PARSABIV Drug Patent Profile

When do Parsabiv patents expire, and when can generic versions of Parsabiv launch?

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
Japan	2016523916
Taiwan	201116290	Therapeutic agents for reducing parathyroid hormone levels
Peru	20160549	FORMULACION LIQUIDA ESTABLE DE ETELCALCETIDA (AMG 416)
European Patent Office	3539555
Taiwan	201542239	Stable liquid formulation

Supplementary Protection Certificates for PARSABIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	SPC/GB17/018	United Kingdom		PRODUCT NAME: ETELCALCETIDE, OR A SALT THEROF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REGISTERED: UK EU/1/16/1142/001-012 20161115; UK PLGB 13832/0039 20161115; UK PLGB 13832/0040 20161115; UK PLGB 13832/0041 20161115
2459208	122017000021	Germany		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	CA 2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	CR 2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
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

Market Dynamics and Financial Trajectory for PARSABIV

Last updated: July 27, 2025

Introduction

PARSABIV (avatrombopag) is a targeted oral thrombopoietin receptor agonist developed by Adapt Pharma (a division of Catalent), approved by the U.S. Food and Drug Administration (FDA) in 2018 for treating thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled for procedures. As an emerging agent in the hematology and liver disease treatment landscape, PARSABIV’s market dynamics are shaped by evolving clinical needs, competitive pressures, regulatory developments, and healthcare system adaptations. This report provides an in-depth analysis of the current and projected market trajectory for PARSABIV, emphasizing the key drivers, barriers, and growth opportunities influencing its commercial potential.

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Market Overview and Clinical Landscape

Thrombocytopenia is a common complication in patients with chronic liver disease, particularly cirrhosis, complicating surgical interventions and invasive procedures. Traditional management options include platelet transfusions, which are associated with limitations such as alloimmunization, short-lived effects, and logistical challenges. The advent of thrombopoietin receptor agonists like PARSABIV offers an innovative, non-transfusional therapeutic approach, stimulating endogenous platelet production.

Regulatory and Labeling Dynamics

Initially approved for adult CLD patients scheduled for procedures, subsequent regulatory reviews are evaluating expanded indications, including broader use in thrombocytopenia caused by hematologic disorders. The FDA's approval was based on pivotal trials demonstrating PARSABIV’s efficacy in elevating platelet counts with a favorable safety profile, specifically in reducing procedure-related bleeding risks.

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Market Drivers

1. Growing Prevalence of Liver Disease

The global burden of liver disease, especially cirrhosis, is escalating. According to the World Health Organization (WHO), over 1.5 billion people globally suffer from some form of chronic liver condition, with millions facing thrombocytopenia complications that necessitate platelet volume management. In the U.S., approximately 4 million adults suffer from some form of chronic liver disease or cirrhosis [1].

2. Limitations of Traditional Therapies

Platelet transfusions, the standard of care, face limitations including short duration of effect, logistical hurdles, and immune sensitization. PARSABIV presents a non-invasive alternative that reduces dependence on transfusions, appealing to clinicians seeking to improve patient outcomes and reduce procedural risks.

3. Clinical Evidence and Safety Profile

Phase III clinical trials demonstrated that PARSABIV significantly increased platelet counts compared to placebo, with a low incidence of adverse events. Its oral administration provides ease of use over injectable alternatives, increasing clinician and patient acceptance.

4. Regulatory and Reimbursement Environment

PARSABIV's initial approval in major markets, alongside favorable reimbursement policies and formulary placements, has facilitated market entry. Continued regulatory endorsements and updates to clinical guidelines are likely to further support utilization.

5. Potential Expanded Indications

Research into PARSABIV’s use beyond procedural thrombocytopenia—such as in chronic immune thrombocytopenic purpura (ITP) or chemotherapy-induced thrombocytopenia—could widen its market footprint, encouraging developers to pursue further clinical trials and expand indications.

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Market Barriers

1. Competitive Landscape

The market faces competition from other thrombopoietin receptor agonists (TPO-RAs) like eltrombopag (Promacta) and romiplostim (Nplate), primarily used for ITP. Additionally, agents like avatrombopag and lusutrombopag are direct competitors targeting thrombocytopenia in liver disease, with PARSABIV competing on safety, efficacy, and dosing convenience.

2. Cost and Healthcare System Constraints

Pricing negotiations and reimbursement caps can influence adoption. High treatment costs compared to transfusions may limit utilization, especially in health systems with strict budget controls.

3. Off-label Use and Clinical Hesitation

While approved for procedural thrombocytopenia, the off-label expansion of use could be hindered by clinician unfamiliarity, limited real-world evidence, or safety concerns regarding potential adverse events such as thromboembolic complications.

4. Regulatory Risks

Potential delays or denials of new indications, or via regulatory scrutiny over safety profiles, may impact long-term market expansion.

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Financial Trajectory and Market Forecast

1. Current Revenue and Uptake

Since its launch in 2018, PARSABIV has captured a niche segment within the thrombocytopenia market, primarily in the U.S. hospital and specialty pharmacy sectors. Early sales reflect initial adoption driven by procedural indications, with steady growth observed as awareness increases.

2. Market Size Estimations

Based on current prevalence data, the U.S. market alone for procedural thrombocytopenia in cirrhotic patients is estimated at approximately $150-$200 million annually. Globally, the market potential is substantially larger, especially in regions with high hepatitis B and C prevalence, which contribute to liver cirrhosis.

3. Growth Drivers and Projections

Sales are projected to grow at a compound annual growth rate (CAGR) of 12-15% over the next five years, driven by:

• Expanded indications (e.g., ITP, chemotherapy-induced thrombocytopenia)
• Broader geographic penetration, particularly in Europe and Asia-Pacific
• Increasing number of procedures requiring platelet management
• Enhanced clinical guidelines endorsing PARSABIV as a preferred option

4. Revenue Outlook

By 2027, revenue estimates for PARSABIV could reach $300-$500 million globally, with the strongest growth in the next 2-3 years contingent on regulatory approvals outside the U.S., successful indication expansion, and competitive positioning.

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Strategic Opportunities

• Indication Expansion: Conducting clinical trials for broader thrombocytopenia indications could unlock new revenue streams.
• Partnerships and Collaborations: Alliances with healthcare providers and health authorities can enhance market penetration.
• Pricing Strategies: Optimizing reimbursement pathways and demonstrating cost-effectiveness will improve uptake.
• Geographical Expansion: Focused efforts in emerging markets with rising liver disease prevalence could accelerate growth.

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Conclusion

PARSABIV’s market dynamics are dictated by its therapeutic niche, safety profile, and expanding clinical evidence base. While competition from existing TPO-RAs and systemic barriers present challenges, the growing burden of liver disease and procedural thrombocytopenia, combined with the drug’s convenience and efficacy, position PARSABIV for meaningful long-term growth. Strategic focus on indication expansion, geographical penetration, and health economic positioning will be critical to realizing its full market potential.

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Key Takeaways

• PARSABIV is positioned as a preferred non-invasive alternative for procedural thrombocytopenia in liver disease, with substantial growth potential.
• The rising global burden of liver disease, especially cirrhosis, underpins market demand.
• Competition and healthcare system constraints require strategic pricing and differentiation.
• Expansion into additional indications and markets is essential for sustained financial trajectory.
• A targeted approach towards regulatory approval, clinical evidence, and payer engagement will optimize revenue growth.

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FAQs

1. What are the primary approved indications for PARSABIV?
   PARSABIV is approved in the United States for increasing platelet counts in adult patients with chronic liver disease scheduled for procedures.

2. How does PARSABIV compare to other thrombopoietin receptor agonists?
   PARSABIV offers oral administration with a favorable safety profile and is specifically indicated for procedure-related thrombocytopenia, whereas agents like eltrombopag and romiplostim are more commonly used for ITP.

3. What factors could influence PARSABIV’s market growth in the next five years?
   Key factors include successful indication expansion, regulatory approvals in additional regions, clinician adoption, reimbursement policies, and increased prevalence of liver disease.

4. Are there any significant safety concerns associated with PARSABIV?
   Unlike some TPO-RAs, PARSABIV has demonstrated a low incidence of adverse events in clinical trials, but ongoing monitoring for thromboembolic events remains critical.

5. What opportunities exist outside of liver disease management for PARSABIV?
   Potential expansion into other thrombocytopenic conditions, such as ITP or chemotherapy-induced thrombocytopenia, through further clinical development.

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References

[1] World Health Organization. Global prevalence of liver disease. WHO Reports, 2022.