Eltrombopag olamine - Generic Drug Details

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

Eltrombopag olamine is the generic ingredient in three branded drugs marketed by Annora Pharma, Novartis, Amneal, Biocon Pharma, Dr Reddys, Hetero Labs Ltd V, Hikma, MSN, Somerset Theraps Llc, and Zydus Pharms, and is included in eleven 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-five patent family members in forty-one countries.

There are three drug master file entries for eltrombopag olamine. Eleven suppliers are listed for this compound.

Summary for eltrombopag olamine

International Patents:	135
US Patents:	6
Tradenames:	3
Applicants:	10
NDAs:	11
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	19
Patent Applications:	526
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

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	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes					Y

International Patents for eltrombopag olamine

Country	Patent Number	Title	Estimated Expiration
Argentina	040083	COMPUESTO BIS-(MONOETANOLAMINA) DEL ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL) -1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDEN] HIDRAZINO] -2'-HIDROXI-[1,1'-BIFENIL]-3-CARBOXILICO, PROCEDIMIENTO PARA PREPARARLO, COMPOSICION FARMACEUTICA QUE LO COMPRENDE, PROCEDIMIENTO PARA PREPARAR DICHA COMPOSICION FARMAC
Austria	452683
Australia	2003241587	3'-((2Z)-(1-(3,4-DIMETHYLPHENYL)-1,5-DIHYDRO-3-METHYL-5-OXO-4H-PYRAZOL-4-YLIDENE)HYDRAZINO)-2'-HYDROXY-(1,1'-BIPHENYL)-3-CARBOXYLIC ACID BIS-(MONOETHANOLAMINE)
Brazil	0310094	Bis-(monoetanolamina)de ácido 3'-[(2z)[1-(3,4-dimetilfenil)-1,5-diiro-3-metil-5-oxo-4h-pira zol-4-ilideno]hidrazino]-2'-hidróxi-[1,1'-bifenil]-3-carb oxìlico

Supplementary Protection Certificates for eltrombopag olamine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	SPC/GB10/026	United Kingdom		PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
1294378	C201000022	Spain		PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 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	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019

Last updated: February 12, 2026

What Are the Market Dynamics for Eltrombopag Olamine?

Eltrombopag olamine is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in various conditions, including idiopathic thrombocytopenic purpura (ITP), hepatitis C-associated thrombocytopenia, and severe aplastic anemia. The drug’s market is influenced by several factors: ongoing clinical development, regulatory approvals, competitive landscape, and regional healthcare policies.

Current Market Size and Growth

• The global market for eltrombopag was valued at approximately $600 million in 2022.
• It is projected to grow at a compound annual growth rate (CAGR) of around 10% over the next five years, reaching nearly $1 billion by 2027.

Key Drivers

• Increasing prevalence of thrombocytopenia-related disorders: ITP affects approximately 3.3 per 100,000 adults annually.
• Expanding indications: FDA approvals in additional diseases, including severe aplastic anemia.
• Growing adoption in emerging markets: Policies favoring the use of newer thrombopoietic agents.

Market Challenges

• Price sensitivity: The high cost restricts uptake in payers with tight budgets.
• Competition: Other thrombopoietin receptor agonists, notably romiplostim and avatrombopag, compete on efficacy, safety, and price.
• Patent cliff: Patent expiration for the original formulation expected around 2024, risking generic entry and price erosion.

Regional Dynamics

Region	Market Size (2022)	Outlook	Key Factors
North America	$300 million	Slower growth	High adoption, regulatory approvals, mature market
Europe	$150 million	Moderate growth	Increasing diagnosis rates, regulatory barriers
Asia-Pacific	$80 million	Rapid growth	Expanding healthcare infrastructure, unmet needs
Rest of World	$70 million	Variable	Limited access, price constraints

Competitive Landscape

• Approved Drugs: Eltrombopag (Promacta, Revolade), romiplostim (Nplate), avatrombopag.
• Pipeline: New formulations and combination therapies are under clinical evaluation.
• Market share: Eltrombopag accounts for roughly 55% of the thrombopoietic drug market.

What Is the Financial Trajectory for Eltrombopag Olamine?

Revenue Projections

• Present revenue: Approximately $600 million globally (2022).
• Forecast 2027: Close to $1 billion, with a CAGR of 10%.
• Regional contributions: North America (~50%), Europe (~25%), Asia-Pacific (~10%), other regions (~15%).

Impact of Patent Expiry

• Patent expiration anticipated around 2024.
• Generic competition expected to reduce prices by 60-70%, impacting revenue streams.
• Companies may attempt extensions through formulation improvements or new indications to delay generic entry.

R&D and Investment Trends

• Investments in new indications, such as myelodysplastic syndromes and aplastic anemia, aim to diversify revenue.
• Biosimilar development is emerging as a major strategic response to patent loss.
• Focused development on oral formulations designed for better patient adherence.

Pricing Landscape

Region	Pricing Trends	Influencing Factors
North America	Stable to slightly declining	Payer negotiations, high development costs
Europe	Slight decline	Reimbursement pressures
Asia-Pacific	Increasing access	Cost-effective alternatives, expanding healthcare budgets
Rest of World	Variable	Regulatory and logistical challenges

Key Considerations for Stakeholders

• Market expansion hinges on approval for new indications and geographic regions.
• Patent cliffs require strategic planning for lifecycle management.
• Pricing strategies need to adapt to regional reimbursement environments.

Key Takeaways

• The global market for eltrombopag olamine is poised for growth before patent expiration.
• Revenue growth is tempered by competitive pressures and price reductions following patent loss.
• Emerging markets and new indications offer future opportunities.
• Patent expiration around 2024 will likely cause a significant reshaping of the market, with biosimilars and generics impacting pricing and market share.
• Investment in drug pipeline expansion and formulation improvements can extend product lifecycle and revenue.

FAQs

1. What diseases does eltrombopag treat?
It treats thrombocytopenia associated with idiopathic thrombocytopenic purpura, hepatitis C, aplastic anemia, and potentially other hematologic conditions.

2. When does its patent expire?
The patent is expected to expire around 2024, opening the market to biosimilar and generic competitors.

3. Which regions represent the largest markets?
North America leads, followed by Europe and Asia-Pacific.

4. What are the main competitors?
Romiplostim and avatrombopag are key rivals, both approved for similar indications.

5. How is the market responding to patent expiration?
Companies are investing in new indications, formulations, and biosimilars to mitigate revenue decline.

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Sources:

1. Global Data. (2022). Market Analysis of Thrombopoietic Agents.
2. FDA. (2022). Drug Approvals and Indications.
3. IQVIA. (2022). Hematology & Oncology Market Trends.
4. ClinicalTrials.gov. (2023). Pipeline and Clinical Development Data.
5. Pharma Intelligence. (2023). Patent Expiry and Biosimilar Entry Planning.