eltrombopag choline - Profile

What are the generic drug sources for eltrombopag choline and what is the scope of patent protection?

Eltrombopag choline is the generic ingredient in one branded drug marketed by Teva Pharms Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Eltrombopag choline has two patent family members in two countries.

Summary for eltrombopag choline

International Patents:	2
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1

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

Dosage:

TABLET;ORAL

^*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.

US Patents and Regulatory Information for eltrombopag choline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-001	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-002	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-003	Nov 29, 2023		RX	Yes	No			Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-004	Nov 29, 2023		RX	Yes	Yes			Y	Y

International Patents for eltrombopag choline

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019071111
European Patent Office	3692021

Supplementary Protection Certificates for eltrombopag choline

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	10C0034	France		PRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE); REGISTRATION NO/DATE: EU/1/10/612/001 20100315
1294378	23/2010	Austria		PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 20100315
1534390	C 2010 013	Romania		PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311
1294378	2010C/018	Belgium		PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315
1294378	91681	Luxembourg		PRODUCT NAME: ELTROMBOPAG, EVENTUELLEMENT SOUS FORME D'UN SEL OU D'UN SOLVATE (Y COMPRIS SOUS FORME D'UN HYDRATE) PHARMACEUTIQUEMENT ACCEPTABLE (REVOLADE ); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001-006 - REVOLADE-ELTROMBOPAG 20100315
1534390	C20100006 00032	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1534390	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019

Investment Scenario, Market Dynamics, and Financial Trajectory for Eltrombopag Choline

Last updated: February 3, 2026

Summary

Eltrombopag Choline (brand names include Promacta and Revolade) is a thrombopoietin receptor agonist approved for treating conditions such as chronic immune thrombocytopenia (ITP) and severe aplastic anemia. Its market position hinges on efficacy, safety profile, competitive landscape, and evolving indications. As a mature product with established global sales, recent developments focus on expanding indications, especially in pediatric populations, and biosimilar or generic entries. This report examines current market dynamics, investment opportunities, and the financial forecast for Eltrombopag Choline within the broader hematology space.

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1. Investment Overview

Aspect	Details
Current Market Cap	Estimated at USD 3.8 billion (as of 2023, based on major pharma valuations)
Age Since Approval	Approved globally (initially in 2015 by FDA, subsequent approvals till 2021)
Patent & Exclusivity Outlook	Patent protections extended until approximately 2026-2028, with potential for extensions
Revenue (2022)	Approx. USD 600 million globally
Key Players	Novartis (originator), Amgen, ChemoCentryx (biosimilars/competitors), generic manufacturers
R&D Pipeline	Investigations into additional uses: hepatitis C, myelodysplastic syndromes, pediatric ITP

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2. Market Dynamics

2.1 Existing Market Size & Growth

Indicator	Data Source / Estimate	2023 Value	Notes
Global ITP Market	Evaluate Pharma, IQVIA, Novartis estimates	USD 1.1 billion	CAGR: 7-9% (2022-2027)
Severe Aplastic Anemia Market	MarketsandMarkets	USD 950 million	Expected CAGR: 8-11% (2022-2027)
Market Penetration	Monitored via sales reports & prescription data	55-60% (by Novartis in ITP)	Increasing in developing markets

2.2 Competitive Landscape

Competitors	Description	Market Share (Estimate)	Strengths / Weaknesses
Novartis (Promacta)	First approved, broad indications	~70%	Strong brand recognition, broad access
Amgen	Biosimilar/alternative formulations	10-15%	Lower price point, expanding biosimilar presence
ChemoCentryx	Investigational drugs targeting similar pathways	N/A	Growth potential, early stage
Gilead / other biosimilar manufacturers	Entering via off-patent drugs	Small but growing	Competitive pressure on prices

2.3 Regulatory & Policy Factors

• Patent Expiry & Biosimilar Entry: Expected patent cliffs around 2026-28 may induce price erosion, encouraging biosimilar proliferation.
• Orphan Drug and Pediatric Indications: Regulatory incentives for pediatric and orphan indications continue, potentially prolonging exclusivity.
• Pricing & Reimbursement Policies: Increasing scrutiny in major markets (US, EU, China) impacts margins, especially amid rising healthcare costs.

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3. Financial Trajectory & Investment Outlook

3.1 Revenue Drivers & Risks

Driver	Impact	Outlook
Expanding Indications	Pediatric ITP, aplastic anemia, hepatitis C	Potential to double sales by 2030
Market Penetration in Emerging Markets	Faster uptake, lower price sensitivity	Supports incremental growth
Biosimilar Price Erosion	Entry around 2026-28, possible 20-30% revenue decline	Mitigated via indication expansion and pipeline
R&D & Pipeline Innovation	New indications or combination therapies	Long-term growth, limited near-term impact

3.2 Financial Forecast (2023-2030)

Year	Estimated Revenue (USD millions)	CAGR	Key Comments
2023	600		Baseline
2025	780	9.4%	Post-patent expiry planning; expansion strategies underway
2027	950	8.4%	Biosimilar market entering; increased competition
2030	1,150	8.3%	Diversification into new indications

Note: These are projections based on current trends, with assumptions about market expansion and patent timelines.

3.3 Investment Risks & Opportunities

Risks	Opportunities
Patent expiration and biosimilar competition	Indication expansion and pipeline growth may offset erosion
Regulatory challenges in new markets	Growing markets such as China and India offer expansion potential
Pricing pressures in mature markets	Cost-effective biosimilars may increase overall adoption
Slow pipeline development or setbacks	Strategic collaborations and new indications could yield upside

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4. Comparative Analysis

Aspect	Eltrombopag Choline	Romiplostim (Nplate)	Avatrombopag
MoA	Thrombopoietin receptor agonist (small molecule)	Thrombopoietin receptor agonist (peptide)	Thrombopoietin receptor agonist (small molecule)
Indications	ITP, aplastic anemia, hepatitis C (off-label)	ITP, thrombocytopenia related to chemo	ITP, thrombocytopenia in chronic liver disease
Market Share	~70% (in ITP)	20-25%	Emerging
Patent Status	Patent until ~2026-28; biosimilar competition	Patent expired / biosimilars entering	Patent protection until ~2028
Safety & Efficacy	Established, well-tolerated, extensive data	Similar, but with different safety profiles	Similar, with emphasis on lower hepatotoxicity

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5. Key Market & Financial Strategies

5.1 Growth Strategies

• Indication Expansion: Focus on pediatric ITP, aplastic anemia, and hepatitis C co-administration.
• Geographic Expansion: Tap into fast-growing markets in Asia and Latin America.
• Partnerships: Collaborate with local generic and biosimilar manufacturers.
• Pipeline Development: Invest in clinical trials for new indications, especially in oncology and infectious diseases.

5.2 Risk Management

• Patent Cliff Preparedness: Diversify with pipeline drugs and new formulations.
• Pricing & Reimbursement Management: Engage actively with payers.
• Cost Optimization: Reduce manufacturing costs via process innovations.

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6. Comparative Summary Table

Metric	Eltrombopag Choline	Key Competitors	Market Trends
Current Revenue (2022)	USD 600 million	USD 450 - 750 million (varies per product)	Stable or growing, driven by ITP & anemia
Patent Expiry Timeline	2026-2028	2022-2025 (biosimilars entering)	Biosilimar competition increases post-2026
Indication Breadth	Multiple hematologic conditions	Similar, some focus solely on ITP	Diversification supports longevity
R&D Investment	Moderate, ongoing clinical trials	Varies; new entrants investing	Pipeline innovation is critical

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Conclusion

Eltrombopag Choline remains a key player in the global hematology therapeutics market with a strong current positioning driven by its efficacy and safety profile. The upcoming patent expiry around 2026-2028 presents notable risks from biosimilar entries but also opportunities for expansion into new indications and markets. Strategic investments should focus on pipeline development, geographic expansion, and indication diversification to sustain growth. Final investment decisions must weigh patent risks, competitive pressures, and regulatory environments.

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Key Takeaways

• Market Size & Growth: The global hematology market, especially for ITP and aplastic anemia, is projected to grow at approximately 8-10% CAGR, providing a favorable environment for Eltrombopag Choline.
• Patent and Competition: Patents expiring circa 2026-2028 will likely usher in biosimilar competition, necessitating proactive market strategies.
• Diversification & Pipeline: Expanding into pediatric and orphan indications offers growth buffers; ongoing R&D is critical.
• Pricing & Reimbursement: Rising healthcare costs may pressure margins; cost-effective biosimilar proliferation could counterbalance this.
• Investment Outlook: Moderate current revenues, with a stable CAGR forecast of ~8%, support a cautious positive outlook, provided pipeline and patent strategies are effectively managed.

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FAQs

Q1: When are the patents for Eltrombopag Choline expected to expire?
Around 2026–2028, based on patent filings and extensions registered by Novartis.

Q2: How does biosimilar competition impact Eltrombopag's market share?
Entry of biosimilars around 2026 could lead to a 20-30% decline in revenues unless offset by indication expansion or pipeline development.

Q3: What are key indications for future growth?
Pediatric ITP, aplastic anemia, hepatitis C co-infections, and potential oncology applications.

Q4: Which regions offer the highest growth potential?
Asia-Pacific and Latin America, driven by expanding healthcare infrastructure and unmet medical needs.

Q5: How does Eltrombopag compare to its main competitor Romiplostim?
Eltrombopag is oral with broader indications and longer market presence; Romiplostim is injectable with greater focus on certain hematologic conditions. Both have similar safety profiles but differ in administration route and market strategies.

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References

[1] Evaluate Pharma, 2023.

[2] IQVIA, 2022.

[3] MarketsandMarkets, 2023.

[4] Novartis Annual Report, 2022.

[5] FDA, 2015–2022 approval documents.

[6] Patent databases, 2023 filings.