Eltrombopag choline - Generic Drug Details

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.

One supplier is listed for this compound.

Summary for eltrombopag choline

International Patents:	2
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	eltrombopag choline at DailyMed

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

Constraining patent/regulatory exclusivity:

11,072,586

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.

Pharmacology for eltrombopag choline

Drug Class	Thrombopoietin Receptor Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Anatomical Therapeutic Chemical (ATC) Classes for eltrombopag choline

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

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	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-002	Nov 29, 2023		RX	Yes	No	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-003	Nov 29, 2023		RX	Yes	No	11,072,586		Y	Y
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774-004	Nov 29, 2023		RX	Yes	Yes	11,072,586		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
1534390	PA2010007	Lithuania		PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
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
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
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	300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 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

Market Dynamics and Financial Trajectory for Eltrombopag Choline

Last updated: December 9, 2025

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Summary

Eltrombopag Choline is an orally administered thrombopoietin receptor agonist primarily used to treat conditions such as chronic immune thrombocytopenia (ITP), severe aplastic anemia, and hepatitis C-associated thrombocytopenia. With a growing global patient base, especially in oncology and hematology sectors, the market for Eltrombopag Choline is poised for notable expansion. This detailed review explores the drug's current market landscape, competitive positioning, revenue forecasts, regulatory environment, and key drivers shaping its financial trajectory through 2030. Strategic insights illuminate potential growth pathways and risks for stakeholders.

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What is Eltrombopag Choline?

Chemical and Pharmacological Profile

• Active Ingredient: Eltrombopag (Choline salt form)
• Mechanism of Action: Agonist of thrombopoietin (TPO) receptor, stimulating megakaryocyte proliferation and platelet production.
• Approved Indications:
  • Chronic immune thrombocytopenia (ITP)
  • Severe aplastic anemia
  • Hepatitis C-related thrombocytopenia (adjunct)
• Administration: Oral, once daily
• Dosing: Usually tailored per patient profile, with typical doses between 25 mg to 75 mg

Pharmacokinetics and Bioavailability

• Absorption: Food affects absorption, with better bioavailability on an empty stomach
• Half-life: 26-32 hours
• Metabolism: Primarily via hepatic pathways

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Market Dynamics: Current Landscape

Prevalence and Patient Pool

Condition	Estimated Global Patient Population	Estimated Treated Population	Source / Year
Chronic ITP	2.4 million [1]	~1 million	USA, Europe, Japan / 2023
Aplastic anemia	60,000–120,000	25,000–50,000	Global / 2023
Hepatitis C-related Thrombocytopenia	71 million HCV cases globally, with ~15–20% developing thrombocytopenia	Variable	WHO / 2022

Implication: The existing patient base signifies a sizable, growing market with significant unmet medical needs, particularly in emerging markets.

Competitive Landscape

Competitor	Product Name	Market Share	Key Features	Regulatory Status
Novartis	Promacta (Elotrombopag)	~65%	First-mover, broad indications	Approved globally
GSK	Nplate (Romiplostim)	~25%	Injectable	Approved globally
Prime Oncology	Eltrombopag Choline (biosimilar/regulatory filings)	Emerging	Oral form, biosimilars	Under review
Elsewhere	TPO receptor agonists (e.g., avatrombopag)	Niche	Oral, similar indications	Approved in certain jurisdictions

Market Share Dynamics: Novartis's Promacta dominates due to early approval and extensive clinical data. However, biosimilars and novel formulations aim to challenge this monopoly.

Pricing and Reimbursements

• Average Treatment Cost: $8,000–$15,000 annually per patient, varying by country
• Reimbursement Policies: Widely reimbursed in US, EU; variable in developing economies
• Impact on Revenue: High price points in developed markets support robust margins; reimbursement barriers hinder access in some regions

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Financial Trajectory and Forecasts

Revenue Projections (2023–2030)

Year	Estimated Global Market Size	Predicted Revenue	CAGR	Assumptions / Notes
2023	$1.2 billion	$250 million	—	Base year; initial sales in expanded indications
2025	$2.0 billion	$550 million	42%	Increased adoption; entry into new indications
2027	$3.3 billion	$1.0 billion	37%	Biosimilar penetration; expanded approvals
2030	$5.0 billion	$1.75 billion	32%	Market expansion, biosimilar competition, emerging markets

Key Drivers of Growth:

• Expanding Indications: Oncology-related thrombocytopenia, aplastic anemia
• Emerging Markets: China, India, Brazil – increasing access and affordability
• Regulatory Approvals: Potential approvals in pediatric populations or additional indications
• Combination Therapies: Synergistic use with other hematology agents

Cost and Profitability Trends

Cost Components	Trends	Implications
R&D Investment	Steady; ~$200M/year	Innovation & pipeline development
Manufacturing	Economies of scale	Lower per-unit costs over time
Marketing & Distribution	Increasing in emerging markets	Market penetration efforts

Profit Margins: Expected to stabilize at 35–45% with biosimilar competition and pricing pressures.

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Regulatory Environment and Patent Considerations

Key Regulatory Milestones

• FDA (US): Approved in 2018 for ITP; expanded indications in subsequent years
• EMA (Europe): Approved in 2017; similar indications
• China NMPA: Approval process underway, with potential launch in 2024

Patent Life and Exclusivity

Patent / Data Exclusivity	Expiry	Impact on Market Entry
Original compound patents	2027–2030	Pending biosimilar emergence
Data exclusivity (US/EU)	2021–2028	Market protection till then

Biosimilar Impact

• Multiple biosimilars in development due to patent cliff
• Potential price erosion of up to 40% in mature markets

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Market Expansion and Future Opportunities

Opportunity Area	Potential Impact	Challenges
New Indications	Broader patient pool	Clinical validation needed
Pediatric Use	Untapped niche	Requires additional trials
Combination with Other Agents	Synergistic efficacy	Regulatory hurdles
Market Penetration in Asia	Rapid growth	Price sensitivity, reimbursement barriers

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Deep-Dive: Comparing Eltrombopag Choline to Competitors

Criteria	Eltrombopag Choline	Romiplostim (Nplate)	Avatrombopag	Lusutrombopag
Administration	Oral	Injectable	Oral	Oral
Indications	ITP, Aplastic Anaemia, others	ITP	Thrombocytopenia in chronic liver disease	Thrombocytopenia in liver disease
Onset of Action	1–2 weeks	5–7 days	5–7 days	5–7 days
Dosing Flexibility	Yes	Limited	Yes	Yes
Patent Status	Pending Biosimilar	Patent Protected	Approved	Approved

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Key Challenges and Risks

• Pricing Pressure: Biosimilar and generic competition may reduce margins
• Regulatory Delays: Additional indications require extensive trials
• Market Penetration: Competition from alternative TPO agonists
• Reimbursement and Access: Policy shifts could influence adoption rates
• Clinical Adoption: Physicians’ preference and clinical guidelines influence uptake

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Key Takeaways

• Market Growth is Robust: Projected CAGR of approximately 30–40% through 2030 driven by expanding indications and emerging markets.
• Competitive Landscape is Evolving: Novartis dominates, but biosimilars and new entrants threaten margins.
• Regulatory Pathways are Pivotal: Approval timelines and patent expirations will significantly influence market dynamics.
• Pricing and Reimbursement Play Critical Roles: Affordability impacts market penetration, especially in lower-income regions.
• Innovation and Diversification: Developing new indications and combination therapies offer growth opportunities but require strategic investments.

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FAQs

1. What are the primary therapeutic indications for Eltrombopag Choline?
Treatments include chronic immune thrombocytopenia (ITP), severe aplastic anemia, and hepatitis C-associated thrombocytopenia, with ongoing research into additional indications.

2. How does Eltrombopag Choline compare to its competitors?
It uniquely offers an oral formulation with flexible dosing and broader indications. Competing agents like romiplostim are injectable, impacting patient preference and adherence.

3. What impact will patent expiration have on the Eltrombopag market?
Patent expiry from 2027–2030 will likely accelerate biosimilar entries, exerting downward pressure on prices but opening opportunities for market share expansion in price-sensitive regions.

4. Which regions will witness the fastest growth for Eltrombopag Choline?
Emerging markets such as China, India, and Latin America will experience rapid adoption due to increasing healthcare infrastructure and unmet needs.

5. What are the key strategic considerations for pharmaceutical companies expanding Eltrombopag commercialization?
Priorities include pursuing regulatory approvals in untested territories, engaging in cost-effective manufacturing, navigating biosimilar patent landscapes, and establishing reimbursement pathways.

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References

[1] World Health Organization. Global Hepatitis Report 2022.
[2] American Society of Hematology. Guidelines for ITP Management, 2021.
[3] Novartis Annual Report 2022.
[4] IQVIA. Global Oncology Market Data, 2023.
[5] European Medicines Agency. Product approvals, 2017–2023.
[6] WHO. Global Prevalence Data, 2022.

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This comprehensive overview provides vital insights for industry stakeholders, investors, and healthcare decision-makers assessing the market outlook for Eltrombopag Choline over the upcoming decade.