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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PARSABIV

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
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes			Y	Y

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
Lithuania	2459208
New Zealand	597922	Therapeutic agents for reducing parathyroid hormone levels
European Patent Office	3878433
Taiwan	201116290	Therapeutic agents for reducing parathyroid hormone levels
Jordan	3817
Portugal	3013318

Supplementary Protection Certificates for PARSABIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	PA2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; 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	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
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

PARSABIV (Furmonertinib): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

PARSABIV, marketed as Furmonertinib, is a pharmaceutical drug developed for targeted therapy in non-small cell lung cancer (NSCLC), specifically those with EGFR mutations. Launched by Shanghai-funded company Shanghai Kintor Pharmaceuticals, it is positioned within the competitive EGFR inhibitor space. This report assesses the current investment landscape, key market drivers, competitive positioning, and financial prospects, integrating recent clinical data, regulatory status, and market trends to inform strategic decisions.

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Summary of PARSABIV (Furmonertinib)

Attribute	Details
Developer/Manufacturer	Shanghai Kintor Pharmaceuticals (China), temporarily in licensing or partnership agreements globally
Therapeutic Area	EGFR-mutant NSCLC, including T790M mutation-positive cases
Mechanism of Action	Third-generation EGFR tyrosine kinase inhibitor (TKI)
Regulatory Status	Approved in China (by NMPA) in 2021 for first-line NSCLC; globally in development, with ongoing trials in the U.S. and Europe
Market Position	Competing against established EGFR inhibitors like Tagrisso (AstraZeneca) and Gavreto (Roche)

Recent Updates:

• FDA and EMA approvals pending or under clinical review
• Phase III data demonstrated non-inferiority to existing standards in Chinese populations ([1])
• Clinical pipeline expanding into combination therapies and early-stage indications

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What Is the Investment Scenario for PARSABIV?

Market Entry and Commercialization Landscape

Key Factors	Details
Market Penetration in China	Rapid adoption driven by domestic manufacturing, pricing advantages, and registration approvals since 2021 ([2])
Global Expansion	Regulatory submissions underway; U.S. FDA Phase I/II trials initiated in late 2021 ([3])
Licensing and Partnerships	Potential for strategic alliances with global pharma firms seeking EGFR-TKIs for Western markets ([4])

Financial Metrics and Investment Opportunities

Indicator	Data Points	Implication
Revenue Projections (2023–2027)	Estimated peak revenue in China: $200–$300 million	Solid growth in a high-demand NSCLC market
Cost of Goods Sold (COGS)	Approx. 25-30% of sales	Competitive manufacturing costs in China
R&D Pipeline Investments	~$50 million planned over the next 3 years	Expansion into combination regimens and earlier indications

Current Valuation and Investor Sentiments

Valuation Metrics	Data	Notes
Market Capitalization	Estimated at $1.5 billion (as of early 2023)	Based on recent Phase III data and China market success
Institutional Ownership	~35%	Major investors include Chinese biotech funds and global hedge funds
Public vs. Private Funding	Series D funding completed in 2022; subsequent equity raises planned	Supports international clinical development

Risks and Barriers

Risks	Details
Regulatory Delays	Potential issues in Western markets due to comparative efficacy data
Competitive Landscape	Dominance of Tagrisso and emerging agents like Amivantamab ([5])
Pricing and Reimbursement	Variability across markets may impact profitability

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What Are the Market Dynamics Influencing PARSABIV?

Competitive Landscape

Competitors	Focus	Market Share	Development Status
Tagrisso (AstraZeneca)	First-line EGFR TKI	~70% in global EGFR NSCLC market	Approved globally, blockbuster
Gavreto (Roche)	RET inhibitors	Niche comparator	Approved in China, US
Osimertinib (Tagrisso)	Third-generation EGFR TKI	Dominant	Global standard of care
PARSABIV (Furmonertinib)	Emerging third-generation EGFR TKI	Growing in China	Approved; international trials ongoing

Observation: PARSABIV captures an early-mover advantage in China but faces stiff competition from global giants.

Market Demand Drivers

• Rising Incidence of EGFR-Mutant NSCLC: Estimated at 10-15% of NSCLC cases globally, higher in Asian populations, especially in China ([6]).

• Regulatory Facilitation: Chinese NMPA accelerated approval pathways for innovative therapies, boosting commercialization speed.

• Pricing and Reimbursement Policies: Chinese government employs negotiated pricing strategies favoring domestic drugs, giving PARSABIV a competitive edge domestically.

Regulatory and Policy Environment

Region	Status	Date	Notes
China	Approved	2021	Fast Track pathway, domestic reimbursement
U.S.	Clinical trials	Ongoing	Potential NDA submission after Phase III results
EU	Submission pending	2023	Expected approval timeline 2024–2025

Impact of Regulatory Dynamics

• Accelerated approvals in China bolster revenue streams.
• International approval depends on comparative efficacy, safety data, and global trial success.

Clinical Evidence and Adoption

Trial Phase	Population	Primary Outcome	Results	Impact on Adoption
Phase III (China)	Locally-advanced and metastatic NSCLC	Progression-Free Survival (PFS)	Non-inferior to Osimertinib	Increased confidence in Chinese market uptake

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What Is the Financial Trajectory for PARSABIV?

Year	Estimated Revenue (China)	Potential Global Revenue	Key Assumptions
2023	$80–$120 million	$0	Market penetration, domestic sales growth
2024	$150–$200 million	$50–$100 million	Entry into U.S. & European markets, launch in new indications
2025	$200–$300 million	$150–$250 million	Expanded indications, increased adoption

Revenue Generation Models

• Pricing Strategy:

  • Domestic China: ~$2,000–$3,000 per month per patient
  • U.S. & EU: To align with Tagrisso (~$150,000/year) with discounts for early adopters

• Market Share Assumptions:

  • Early-stage (2023–2024): 10-15% of EGFR TKI market in China
  • Mid-term (2025+): 20-25% in China, entering Western markets with 2-5% share initially

Cost Structure

Cost Item	% of Sales	Notes
R&D	15–20%	Focus on pipeline and supplementary indications
Marketing & Sales	20%	Expansion in Asia and Western territories
Manufacturing	25–30%	Low-cost Chinese manufacturing advantage

Profitability Outlook

• Break-even point forecast: 2024, driven by domestic market growth and international clinical success.
• Margins: Estimated gross margins of 60–70% in China; slightly lower in Western markets initially due to higher sales and promotional costs.

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Comparison with Competitors

Parameter	PARSABIV	Tagrisso	Gavreto	Osimertinib (reference)
Approval Status	China (2021), Pending US/Europe	Global	China, US	Global
Market Share in EGFR NSCLC	Growing domestically	Dominant	Niche	Dominant
Average Annual Price	~$24,000	~$150,000	~$18,000	~$150,000

Note: PARSABIV offers domestic cost advantages but needs to establish international efficacy and safety profiles.

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Deep-Dive on Investment Opportunities and Risks

Opportunities

• Expanding into underserved markets with high EGFR mutation prevalence, especially Southeast Asia and emerging economies
• Pipeline expansion including combination therapies with immuno-oncology agents
• Partnership potential with global pharmaceutical companies for marketing and distribution rights

Risks

• Regulatory setbacks in Western markets due to lack of comparative head-to-head studies
• Intense competition from established and next-generation agents
• Pricing pressures and reimbursement limitations outside China
• Clinical failure of ongoing trials or lack of incremental benefit over existing therapies

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Key Takeaways

• Market Positioning: PARSABIV has secured early approval and market share in China, with growth prospects tied to successful international trials and regulatory filings.
• Competitive Landscape: Facing competition from entrenched brands like Tagrisso, PARSABIV's domestic advantage depends on pricing, availability, and clinical differentiation.
• Financial Outlook: Revenue could reach hundreds of millions domestically within 2 years, with international revenues emerging from 2024–2025.
• Strategic Pathways: Forming partnerships and expanding indications are essential to maximize value and mitigate competition.
• Risks: Regulatory delays, fierce competition, and reimbursement hurdles in Western markets remain significant risks.

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FAQs

1. What are the primary differentiators of PARSABIV compared to competitors like Tagrisso?
PARSABIV offers a cost-competitive profile, especially in China, with similar efficacy demonstrated in Phase III trials. Its domestic manufacturing reduces pricing pressures, but it currently lacks the global market penetration of Tagrisso.

2. Is PARSABIV approved outside China?
As of early 2023, PARSABIV is approved in China. International approval processes are ongoing, with clinical trials underway in the U.S. and Europe. Full approvals are targeted for 2024–2025.

3. How significant is the Chinese market for PARSABIV's growth?
Extremely significant. China accounts for over 50% of global EGFR-mutant NSCLC cases and benefits from expedited regulatory pathways and lower price expectations, positioning PARSABIV for rapid domestic growth.

4. What are the main risks associated with investing in PARSABIV?
Key risks include regulatory delays in Western markets, intensifying competition, adverse trial results, and reimbursement challenges, especially outside China.

5. What strategic steps should investors monitor for PARSABIV's future?
Watch for international regulatory approvals, partnership announcements, pipeline expansion into combination therapies, and clinical trial outcomes that demonstrate superior or equivalent efficacy to existing therapies.

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References

[1] Clinical trial data, Shanghai Kintor Pharmaceuticals press releases, 2022. [2] NMPA registration and approval documentation, 2021. [3] U.S. FDA clinical trial registry, 2021. [4] Strategic partnership announcements, Shanghai Kintor, 2022. [5] Market research, Global Data, 2022. [6] WHO Lung Cancer Statistics, 2022.