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 and Novartis, and is included in three 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 eight patent family members in forty countries.

There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.

Summary for eltrombopag olamine

International Patents:	108
US Patents:	6
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	16
Patent Applications:	465
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
National Taiwan University Hospital	Phase 2
Novartis	Phase 2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 4

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	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y

Expired US Patents for eltrombopag olamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011

International Patents for eltrombopag olamine

Country	Patent Number	Title	Estimated Expiration
South Africa	200907710	NOVEL PHARMACEUICAL COMPOSITION
European Patent Office	1534390	ACIDE 3'- (2Z)- 1-(3,4-DIMETHYLPHENYL)-1,5-DIHYDRO-3-METHYL-5-OXO-4H-PYRAZOL-4-YLIDENE HYDRAZINO -2'-HYDROXY- 1,1'-BIPHENYL -3-CARBOXYLIQUE BIS-(MONOETHANOLAMINE) (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))
Japan	6560289
Jordan	3643	مركبات صيدلانية جديدة (Novel pharmaceutical composition)
Eurasian Patent Organization	034294	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ОЛАМИНА ЭЛЬТРОМБОПАГА (PHARMACEUTICAL COMPOSITION OF ELTROMBOPAG OLAMINE)
Colombia	6260058	COMPOSICIONES QUE CONTIENEN BIS-(MONOETANOLAMINA) DEL ACIDO 3 ́-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2 ́HIDROXI-[1,1 ́-BIFENIL]-3-CARBOXILICO (ELTROMBOPAG OLAMINA) Y PROCESOS PARA SU PREPARACION .

Supplementary Protection Certificates for eltrombopag olamine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	2010/020	Ireland		PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
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	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	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 00032	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378	C300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311

Eltrombopag olamine Market Analysis and Financial Projection Experimental

Eltrombopag Olamine Market Dynamics and Financial Trajectory

Market Overview

Eltrombopag Olamine, a thrombopoietin receptor agonist, is a crucial medication for increasing platelet production in patients with conditions such as chronic immune thrombocytopenia (ITP) and chronic hepatitis C virus (HCV) infection. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The Eltrombopag Olamine market is anticipated to experience significant growth over the forecast period. By 2034, the market is projected to reach a substantial value, with a compound annual growth rate (CAGR) of several percent from 2024 to 2034[1][4].

API Market Specifics

In the context of the active pharmaceutical ingredient (API) market, Eltrombopag Olamine is valued at USD 355.95 million in 2024 and is expected to grow to USD 611.6 million by 2032, exhibiting a CAGR of 7.00% during this period[3].

Regional Market Insights

North America

North America dominates the Eltrombopag Olamine market, accounting for more than 46% of the global market share. This dominance is attributed to the region's sophisticated healthcare infrastructure, high prevalence of target diseases, and favorable reimbursement policies[1][3].

Europe

Europe's market benefits from the rising incidence of cancer and other conditions that require Eltrombopag Olamine. The region's favorable reimbursement policies and growing elderly population also drive demand. Research and development activities in Europe further contribute to market expansion[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. This growth is driven by the increasing burden of chronic diseases, rising disposable income, and growing government investments in healthcare. China and India are identified as key growth markets in this region[1].

Key Market Players

The Eltrombopag Olamine market is dominated by several large pharmaceutical companies, including:

• GlaxoSmithKline
• Novartis Pharmaceuticals
• Selleck Chemicals
• Adooq Bioscience
• Taiclone
• CSNpharm
• MedKoo
• Others[1][3].

Market Drivers

Increasing Prevalence of Target Diseases

The growing prevalence of thrombocytopenia-related disorders, such as chronic ITP and HCV infection, is a significant driver of the Eltrombopag Olamine market. This increase in disease incidence heightens awareness among healthcare professionals and patients, leading to more proactive screening, diagnosis, and treatment[3].

Expanding Indications and Treatment Options

Continuous research and clinical trials are expanding the therapeutic uses of Eltrombopag Olamine beyond its traditional applications. This includes exploring its efficacy in other hematologic conditions and potential synergies with existing therapies, which broadens the market potential and attracts increased investment[3].

Favorable Reimbursement Policies

Favorable reimbursement policies in regions like North America and Europe support the market growth by making the medication more accessible to patients. These policies help in reducing the financial burden on patients, thereby increasing the adoption rate of Eltrombopag Olamine[1][3].

Market Restraints

Regulatory Hurdles

Variations in regulatory requirements across different regions pose significant challenges for market entry and expansion. Companies must navigate multiple regulatory pathways, which can complicate the approval process and limit the availability of innovative treatment options[3].

Cost-Utility Analysis

The cost-utility analysis of Eltrombopag Olamine, particularly in the context of antiviral therapy for HCV, shows that while it is effective, it can be costly. For instance, the cost per quality-adjusted life-year (QALY) can range from $90,060 to $166,040, depending on the patient subgroup, which may affect its adoption in some markets[2].

Financial Trajectory

Revenue Projections

The Eltrombopag Olamine API market is projected to grow from USD 355.95 million in 2024 to USD 611.6 million by 2032. This growth is driven by increasing demand for effective treatments and the expansion of therapeutic indications[3].

Cost and Pricing

The cost of Eltrombopag Olamine can be significant, with cost-utility analyses indicating high costs per QALY. However, the medication's efficacy and the growing demand for it support its price and accessibility, driving global market expansion[2][3].

Key Takeaways

• Market Growth: The Eltrombopag Olamine market is expected to grow significantly, driven by increasing prevalence of target diseases and expanding therapeutic indications.
• Regional Dominance: North America leads the market, followed by Europe and the Asia Pacific region.
• Key Players: Major pharmaceutical companies dominate the market, including GlaxoSmithKline and Novartis Pharmaceuticals.
• Market Drivers: Increasing disease prevalence, favorable reimbursement policies, and expanding treatment options are key drivers.
• Market Restraints: Regulatory hurdles and high costs per QALY are significant restraints.

FAQs

What is Eltrombopag Olamine used for?

Eltrombopag Olamine is used to treat low platelet counts in patients with conditions such as chronic immune thrombocytopenia (ITP) and chronic hepatitis C virus (HCV) infection.

Which region dominates the Eltrombopag Olamine market?

North America dominates the Eltrombopag Olamine market, accounting for more than 46% of the global market share.

What is the projected CAGR for the Eltrombopag Olamine API market?

The Eltrombopag Olamine API market is projected to grow at a CAGR of 7.00% from 2024 to 2032.

Who are the key players in the Eltrombopag Olamine market?

Key players include GlaxoSmithKline, Novartis Pharmaceuticals, Selleck Chemicals, Adooq Bioscience, and others.

What are the main drivers of the Eltrombopag Olamine market?

The main drivers include increasing prevalence of target diseases, favorable reimbursement policies, and expanding therapeutic indications.

Sources

1. We Market Research: Global Eltrombopag Olamine Market Size, Segmentation, Regional ...
2. NCBI: EXECUTIVE SUMMARY - Eltrombopag Olamine (Revolade)
3. Global Growth Insights: Eltrombopag Olamine API Market Size, Share, Trend, Growth 2032
4. Market Research Intellect: Global Eltrombopag Olamine Market Size, Trends and Projections
5. Synapse: Eltrombopag Diolamine - Drug Targets, Indications, Patents