Eltrombopag olamine - Generic Drug Details

What are the generic sources for eltrombopag olamine and what is the scope of freedom to operate?

Eltrombopag olamine is the generic ingredient in three branded drugs marketed by Annora Pharma, Novartis, and Hetero Labs Ltd V, and is included in four NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Eltrombopag olamine has one hundred and thirty-four patent family members in forty-one countries.

There are three drug master file entries for eltrombopag olamine. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for eltrombopag olamine

International Patents:	134
US Patents:	6
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	19
Patent Applications:	1,266
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eltrombopag olamine
What excipients (inactive ingredients) are in eltrombopag olamine?	eltrombopag olamine excipients list
DailyMed Link:	eltrombopag olamine at DailyMed

Recent Clinical Trials for eltrombopag olamine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	PHASE4
National Taiwan University Hospital	Phase 2
Novartis	Phase 2

See all eltrombopag olamine clinical trials

Generic filers with tentative approvals for ELTROMBOPAG OLAMINE

Applicant	Application No.	Strength	Dosage Form
		25MG	TABLET
		12.5MG	TABLET
		50MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for eltrombopag olamine

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 olamine

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

Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROMACTA KIT	For Oral Suspension	eltrombopag olamine	12.5 mg/packet and 25 mg/packet	207027	1	2022-04-22
PROMACTA	Tablets	eltrombopag olamine	12.5 mg and 25 mg	022291	1	2014-02-04
PROMACTA	Tablets	eltrombopag olamine	50 mg and 75 mg	022291	1	2014-01-07

US Patents and Regulatory Information for eltrombopag olamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	AB	RX	Yes	No	8,071,129*PED				Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes	8,062,665*PED				Y
Annora Pharma	ELTROMBOPAG OLAMINE	eltrombopag olamine	FOR SUSPENSION;ORAL	216620-002	Apr 18, 2024	AB	RX	No	No
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No	8,062,665*PED				Y

Expired US Patents for eltrombopag olamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,795,293*PED
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	7,473,686*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	7,473,686*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	7,473,686*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	7,795,293*PED

International Patents for eltrombopag olamine

Country	Patent Number	Title	Estimated Expiration
South Korea	101632851
Argentina	059656
European Patent Office	4218732
Spain	2565179
New Zealand	580888

Supplementary Protection Certificates for eltrombopag olamine

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

Market Dynamics and Financial Trajectory for Eltrombopag Olamine

Last updated: July 27, 2025

Introduction

Eltrombopag olamine, marketed under the brand name Promacta and Revolade, is a synthetic, non-peptide thrombopoietin receptor agonist primarily approved for the treatment of thrombocytopenia caused by chronic immune thrombocytopenic purpura (ITP), hepatitis C-associated thrombocytopenia, and severe aplastic anemia. Since its FDA approval in 2008, eltrombopag has garnered significant attention within hematology, influencing market dynamics and shaping its financial trajectory globally. This analysis explores the key drivers, challenges, competitive landscape, and economic outlook for eltrombopag olamine over the coming years.

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Market Overview and Indication Expansion

Initially approved for chronic immune thrombocytopenic purpura (ITP), eltrombopag’s therapeutic indications have expanded, fostering broader market opportunities. The drug's efficacy in stimulating platelet production offers vital benefits to patients unresponsive to traditional therapies, including corticosteroids and immunoglobulins. Subsequently, approval for hepatitis C-related thrombocytopenia in conjunction with antiviral therapy and for severe aplastic anemia (SAA) has cemented eltrombopag’s role in hematology, positioning it as a critical asset within specialty pharmaceuticals.

The global market for thrombopoietin receptor agonists, including eltrombopag and rival agents such as romiplostim, is forecasted to grow at a compound annual growth rate (CAGR) of approximately 8-10% between 2022 and 2030 (Fortune Business Insights, 2022). This trajectory aligns with increasing disease prevalence, heightened diagnostic rates, and expanding therapeutic applications.

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Market Drivers

1. Growing Prevalence of Targeted Diseases

Thrombocytopenia, particularly chronic ITP, remains prevalent in developed markets, with estimates indicating a prevalence of approximately 3.3 per 100,000 adults for adult ITP (AMA, 2021). The global increase in hepatitis C infections, despite declining incidences in some regions, sustains demand for adjunct therapies such as eltrombopag. Moreover, severe aplastic anemia’s rising recognition among hematological disorders in both pediatric and adult populations supports ongoing market expansion.

2. Advancements in Treatment Guidelines

Evolving clinical guidelines increasingly recognize thrombopoietin receptor agonists as first-line or second-line therapies for ITP and SAA, driven by their efficacy and manageable safety profiles. The American Society of Hematology (ASH) and European Hematology Association (EHA) endorse eltrombopag as a viable option, optimizing prescription volumes.

3. Competitive Position and Patent Portfolio

Eltrombopag’s patent exclusivity, notably in major markets like the U.S. and EU, offers a competitive moat. Patent protections, extended through formulations and combination therapies, are set to expire progressively over the next decade, potentially ushering in generic competition.

4. Rising Healthcare Expenditure and Improved Diagnostics

Global healthcare expenditure increases facilitate access to advanced hematology treatments. Furthermore, improved diagnostic capabilities lead to earlier detection of thrombocytopenia, augmenting treatment adoption rates.

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Challenges Facing Market Growth

1. Patent Expiry and Generic Competition

The expiration of key patents poses a significant threat to eltrombopag’s market share. Emerging generics and biosimilars are expected to enter markets post-patent expiry, exerting downward pressure on prices. For instance, the U.S. patent for eltrombopag is set to expire around 2026, raising concerns about erosion of revenue streams (FDA, 2021).

2. Side Effect Profile and Safety Concerns

Eltrombopag’s adverse effects, including hepatotoxicity, thromboembolic events, and cataracts, necessitate close monitoring, potentially hindering widespread adoption. Additionally, patient-specific factors like liver impairment require dosage adjustments, complicating treatment protocols.

3. Competition from Alternative Agents

Romiplostim and avatrombopag are primary competitors. While eltrombopag’s oral administration confers convenience over injectable romiplostim, differences in efficacy, safety, and cost influence prescriber preferences.

4. Pricing and Reimbursement Challenges

Cost containment pressures and stringent reimbursement policies mediate the drug’s financial trajectory. Payers favor cost-effective alternatives, particularly once generics enter the market.

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Financial Trajectory and Revenue Projections

Historical Revenue Performance

In 2021, global sales of eltrombopag approximated $700 million, with North America accounting for over 60% of revenues (EvaluatePharma, 2022). Growth during 2018-2021 was driven by increased adoption in chronic ITP and SAA, alongside expanding indications in emerging markets.

Forecasting Future Revenues

The next decade’s outlook hinges on patent expiration timelines, pipeline developments, and competitive dynamics. Analysts project:

• Pre-Patent Expiry (2023-2026): Moderate growth, with revenues plateauing or slightly increasing owing to expanded indications and improved treatment adherence.

• Post-Patent Expiry (2026+): Revenues are expected to decline by up to 30-50% over the subsequent 3-5 years, contingent on the entry of generic competitors and pricing strategies (IQVIA, 2022).

Potential for Market Share Retention

Pharmaceutical companies may deploy lifecycle management strategies, including formulation enhancements, combination therapies, and strategic pricing, to sustain revenues amid generic entry. Additionally, expanding into new indications—such as hematopoietic stem cell transplantation—could offset declining sales.

Emerging Markets and Access

Growth in emerging economies presents lucrative avenues. Increasing healthcare access, government reforms, and rising disease awareness are likely to boost sales, potentially balanced against price sensitivity.

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Regulatory and Patent Landscape

Regulatory environments significantly influence market participation. Securing approvals in China, India, and Latin America broadens revenue streams. However, patent litigations and expiry threaten exclusivity, emphasizing the importance of strategic patent filings and litigation defenses.

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Pipeline and Future Opportunities

Ongoing clinical trials evaluate eltrombopag’s utility in other thrombocytopenic and hematological conditions, including solid tumors and autoimmune disorders. Success in these areas could extend the drug’s revenue lifespan and market relevance.

Sample Pipeline Developments:

• Combination therapy trials with immunomodulators.
• New formulations targeting pediatric populations.
• Investigational uses in myelodysplastic syndromes.

The potential for on-label expansion, coupled with strategic partnerships, underscores the compound’s long-term financial prospects.

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Key Takeaways

• Market growth is driven by increased disease prevalence, evolving clinical guidelines, and expanded indications, with a projected CAGR of 8-10% until 2030.
• Patent expiration from 2026 onwards signals imminent revenue erosion absent robust lifecycle management strategies.
• Competition from generics and alternative agents like romiplostim threaten market share, compelling pricing and negotiation strategies.
• Emerging markets present promising growth opportunities but require considerations around healthcare infrastructure and pricing policies.
• Pipeline pipeline portion and new indication approvals offer potential revenue extension, contingent on successful clinical outcomes.

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FAQs

1. When will the patent for eltrombopag olamine expire, and what does it mean for the market?
The primary patent in the U.S. is set to expire around 2026, opening the door for generic competition which could significantly reduce revenues, prompting companies to explore lifecycle management strategies.

2. How does eltrombopag compare with rival thrombopoietin receptor agonists?
Eltrombopag’s oral administration offers convenience over injectable alternatives like romiplostim. Differences in efficacy, safety profiles, and pricing influence clinician preferences. Ongoing head-to-head studies continue to define its comparative positioning.

3. What are the main challenges facing eltrombopag’s growth?
Major hurdles include patent expiration, potential safety concerns, competitive pressure from biosimilars, and reimbursement constraints, especially in cost-sensitive regions.

4. What are potential areas of expansion for eltrombopag?
Future indications include broader autoimmune hematological disorders and possibly incorporation into combination regimens. Pediatric formulations are also under investigation.

5. How are emerging markets influencing eltrombopag’s global sales?
Growing healthcare infrastructure, increasing disease awareness, and evolving reimbursement policies in regions like Asia and Latin America are expanding access, potentially boosting sales despite price sensitivity.

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References

1. Fortune Business Insights. (2022). Thrombopoietin Receptor Agonists Market Size, Share & Industry Analysis. https://www.fortunebusinessinsights.com/industry-reports/thrombopoietin-receptor-agonists-market-101212

2. American Medical Association. (2021). Hematologic Disorders Prevalence Data. AMA Journal of Ethics.

3. FDA. (2021). Patent and Exclusivity Data for Eltrombopag. https://www.fda.gov

4. EvaluatePharma. (2022). Global Oncology & Hematology Therapeutics Market Report.

5. IQVIA. (2022). Pharmaceutical Market Forecast Database.

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In conclusion, eltrombopag olamine stands at a pivotal juncture within the hematology therapeutic landscape. Its sustained market presence depends on strategic lifecycle management, pipeline success, and adaptability to competitive and regulatory shifts. Businesses must navigate patent timelines, explore emerging indications, and capitalize on expanding markets to optimize financial outcomes.