PROMACTA Drug Patent Profile

Which patents cover Promacta, and when can generic versions of Promacta launch?

Promacta is a drug marketed by Novartis and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-four patent family members in forty-one countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Promacta

A generic version of PROMACTA was approved as eltrombopag olamine by ANNORA PHARMA on April 18^th, 2024.

Summary for PROMACTA

International Patents:	134
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	31
Patent Applications:	671
Drug Prices:	Drug price information for PROMACTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROMACTA
What excipients (inactive ingredients) are in PROMACTA?	PROMACTA excipients list
DailyMed Link:	PROMACTA at DailyMed

See drug prices for PROMACTA

Recent Clinical Trials for PROMACTA

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

Sponsor	Phase
University of California, San Francisco	Phase 1
Food and Drug Administration (FDA)	Phase 1
University of California, Davis	Phase 1

See all PROMACTA clinical trials

Pharmacology for PROMACTA

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

Paragraph IV (Patent) Challenges for PROMACTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 PROMACTA

PROMACTA is protected by six US patents and one FDA Regulatory Exclusivity.

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	207027-002	Sep 27, 2018	AB	RX	Yes	No
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes	7,547,719*PED				Y

Expired US Patents for PROMACTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	6,280,959*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	6,280,959*PED
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	6,280,959*PED

International Patents for PROMACTA

When does loss-of-exclusivity occur for PROMACTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PROMACTA around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2007002242
Australia	2016202063
Slovenia	1534390

Supplementary Protection Certificates for PROMACTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1534390	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
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

Market Dynamics and Financial Trajectory for PROMACTA (Eltrombopag)

Last updated: July 27, 2025

Introduction

PROMACTA (eltrombopag) is an oral thrombopoietin receptor agonist developed by GlaxoSmithKline (GSK), primarily indicated for thrombocytopenia associated with chronic immune thrombocytopenic purpura (ITP), hepatitis C–induced thrombocytopenia, and severe aplastic anemia. Since its approval, PROMACTA has established a significant footprint within hematology and onco-hematology markets. This report assesses the current market dynamics and forecasts the financial trajectory of PROMACTA, considering emerging trends, competitive landscape, regulatory developments, and regional demand.

Market Overview and Key Drivers

Core Indications Fuelling Growth

PROMACTA targets patients with conditions characterized by low platelet counts, an unmet clinical need with limited therapeutic options historically. Its primary indications—ITP, hepatitis C-related thrombocytopenia, and severe aplastic anemia—drive sustained demand, supported by improvements in patient outcomes and treatment guidelines favoring thrombopoietin receptor agonists.

Expanding Indications and Off-label Use

Recent clinical data and expanded approvals broaden PROMACTA’s use, notably in severe aplastic anemia, approved by the FDA in 2019. Ongoing trials explore applications in other hematologic disorders, potentially expanding its market reach. Off-label use in “difficult-to-treat” thrombocytopenic syndromes further bolsters sales.

Competitive Landscape

PROMACTA faces competition mainly from Nplate (romiplostim) by Amgen, a biologic thrombopoietin mimetic, and newer agents like avatrombopag. While biologics like Nplate require parenteral administration, PROMACTA’s oral route confers convenience and adherence advantages, reinforcing its market position. Still, generic entrants and biosimilars pose long-term competitive threats.

Market Growth Factors

• Growing Prevalence of Hematologic Disorders: Increasing diagnosis rates of ITP and aplastic anemia, driven by improved detection, elevate market potential.
• Patient-Centric Treatment Preference: Oral formulations like PROMACTA satisfy demand for easier-to-administer therapies.
• Regulatory Approvals: Expanded indications and regional approvals facilitate broader market access, especially in emerging markets.
• Healthcare Infrastructure: Enhanced diagnostic capabilities and evolving treatment guidelines optimize patient identification and treatment initiation.

Pricing and Reimbursement Trends

The pricing strategy varies by region, with premium pricing justified by clinical benefits, especially in US and Europe. Reimbursement policies and health technology assessments (HTAs) influence market access; in some regions, cost-effectiveness evaluations may moderate sales growth.

Regional Market Dynamics

United States

The US remains the largest market, accounting for a substantial share of PROMACTA’s revenue. Growing awareness, aggressive marketing, and expanded indications contribute to sustained growth. The healthcare system’s reimbursement mechanisms ensure high accessibility, contingent on formulary placements.

Europe

European markets exhibit steady growth, driven by approvals in member states and shifting treatment paradigms favoring oral agents. Pricing pressures and NHS budget constraints influence net sales.

Emerging Markets

Regions like Asia-Pacific, Latin America, and the Middle East herald expanding opportunities, supported by increasing healthcare spending, rising prevalence of thrombocytopenic conditions, and regulatory approvals. However, pricing and reimbursement hurdles and healthcare infrastructure gaps pose challenges.

Regulatory and Clinical Development Landscape

Ongoing clinical trials exploring PROMACTA’s applicability to additional indications, such as myelodysplastic syndromes and post-transplant thrombocytopenia, could generate new revenue streams. Regulatory approvals in these domains could significantly alter its market dynamics.

Regulatory Considerations

• Post-Marketing Surveillance: Vigilance on adverse events like hepatotoxicity influences labeling and prescribing practices.
• Accelerated Approvals and REMS Programs: Regulatory mechanisms influence market access timelines and pricing negotiations.

Financial Trajectory and Forecast

Historical Performance

Since its launch, PROMACTA has demonstrated robust sales growth, particularly in the US, with a compound annual growth rate (CAGR) approximating 15–20% pre-pandemic. GSK’s strategic emphasis on hematology portfolios has sustained sales momentum, although recent global health crises have introduced variability.

Future Market Projections

Forecasts project a compound annual growth rate of 8–12% over the next five years, driven by:

• Increasing patient populations.
• Broader indication approvals.
• Expansion into newly researched hematological conditions.
• Penetration into emerging markets.

Revenue estimates suggest that PROMACTA could generate $2.5 to $3 billion annually by 2027, assuming steady growth and successful clinical trail completions for new indications.

Key Factors Influencing Financial Trajectory

• Pricing and Reimbursement Policies: Regional economic developments and HTA outcomes will affect pricing strategies.
• Market Penetration of Competitors: The entrance of biosimilars or alternative agents could compress margins.
• Pipeline Success: Positive trial results and regulatory approvals for new indications will further enrich revenue.
• Supply Chain and Manufacturing: Ensuring consistent supply amid global disruptions remains crucial.

Challenges and Risks

• Safety Profile and Regulatory Scrutiny: Incidents of hepatotoxicity and other adverse events could lead to usage restrictions.
• Market Saturation and Competition: Biologic competitors and biosimilars threaten market share.
• Pricing Pressures: Governments and payers increasingly emphasize value-based pricing.
• Patent Expirations: Patent renewals and expirations threaten to erode exclusivity and revenue streams.

Conclusion

PROMACTA continues to demonstrate a resilient market presence bolstered by its oral administration, expanding indications, and regional growth opportunities. Its financial trajectory remains promising, although contingent on clinical, regulatory, and competitive developments. Strategic focus on innovating indications, maintaining cost-effective pricing strategies, and expanding into high-growth markets will be critical for maximizing its long-term value.

Key Takeaways

• PROMACTA’s monolithic position in thrombocytopenia treatment hinges on clinical efficacy, ease of use, and evolving indications.
• The compound’s growth is buoyed by expanding indications, infrastructure development in emerging markets, and strategic regulatory approvals.
• Competitive threats from biologic agents and biosimilars underscore the need for continuous innovation and differentiation.
• Financial outlooks forecast sustained growth, potentially reaching over $3 billion annually by 2027, provided that clinical and market challenges are navigated effectively.
• Stakeholders should monitor regulatory decisions, pipeline progress, and regional reimbursement policies to optimize investment and commercial strategies.

FAQs

1. What are the primary indications for PROMACTA?
   PROMACTA is primarily indicated for chronic immune thrombocytopenic purpura (ITP), hepatitis C–associated thrombocytopenia, and severe aplastic anemia.

2. How does PROMACTA differ from its competitors?
   Unlike biologic agents such as Nplate, PROMACTA is an oral medication, offering superior convenience and patient compliance. It also has an expanding evidence base supporting multiple hematological indications.

3. What factors could hinder PROMACTA’s market growth?
   Potential hurdles include safety concerns, regulatory restrictions, pricing pressures, competition from biosimilars, and emerging alternative therapies.

4. What is the outlook for PROMACTA in emerging markets?
   The outlook is cautiously optimistic, with growth driven by increasing healthcare infrastructure, better disease awareness, and regional approval. However, affordability and infrastructure gaps remain challenges.

5. What new indications are in development for PROMACTA?
   Clinical trials are exploring applications in myelodysplastic syndromes, post-transplant thrombocytopenia, and potentially other hematological conditions, which could expand market opportunities.

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Sources:

[1] GlaxoSmithKline. PROMACTA (eltrombopag) prescribing information.
[2] Evaluate Pharma, 2023. Hematology market forecasts.
[3] U.S. Food and Drug Administration (FDA). Approved indications for PROMACTA.
[4] Market research reports from IQVIA and GlobalData.
[5] Clinical trial repositories and recent publications on hematology therapies.