PROMACTA Drug Patent Profile

Which patents cover Promacta, and what generic alternatives are available?

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-five 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. Eleven 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:	135
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.

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	022291-004	Oct 20, 2011	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
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	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 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
Japan	2014005302
Hong Kong	1136968
Russian Federation	2004137491	БИС-(МОНОЭТАНОЛАМИН) 3`-[(2Z)-[1-(3,4-ДИМЕТИЛФЕНИЛ)-1,5-ДИГИДРО-3-МЕТИЛ-5-ОКСО-4H-ПИРАЗОЛ-4- ИЛДЕН] ГИДРАЗИНО]-2`-ГИДРОКСИ-[1,1`-БИФЕНИЛ]-3-КАРБОНОВОЙ КИСЛОТЫ
New Zealand	580888	Compositions of eltrombopag olamine substantially free from coordinating metals or reducing sugars
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
Japan	2017137343
Germany	69839191

Supplementary Protection Certificates for PROMACTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534390	91 3-2010	Slovakia		PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1534390	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
1294378	2010C/018	Belgium		PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 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
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	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

PROMACTA (Eltrombopag) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

PROMACTA (eltrombopag) is a thrombopoietin receptor agonist approved for treating chronic immune thrombocytopenia (ITP) and severe aplastic anemia. Market performance is driven by its efficacy, expanding indications, and patent landscape.

What is PROMACTA's Approved Indication and Mechanism of Action?

PROMACTA is a small molecule thrombopoietin receptor agonist. It stimulates megakaryopoiesis, the process by which platelets are produced, by binding to and activating the transmembrane protein CD110, the thrombopoietin receptor [1]. This action leads to an increase in platelet production.

Initially approved by the U.S. Food and Drug Administration (FDA) in 2008, PROMACTA received approval for:

• Chronic Immune Thrombocytopenia (ITP): For patients aged 1 year and older who have had an insufficient response to corticosteroids, immunoglobulin, or plasma exchange.
• Severe Aplastic Anemia (SAA): In combination with immunosuppressive therapy for patients aged 2 years and older who are newly diagnosed or have had a suboptimal response to prior immunosuppressive therapy [2].
• Thrombocytopenia associated with Chronic Hepatitis C: To reduce the risk of bleeding associated with thrombocytopenia in patients with chronic hepatitis C [3]. This indication was later withdrawn in 2019 in the US due to shifting treatment paradigms for Hepatitis C [4].

The drug is administered orally, offering a convenient alternative to injectable treatments.

What is PROMACTA's Global Market Size and Growth Trajectory?

PROMACTA, marketed by Novartis, has demonstrated significant market traction. In 2021, it generated approximately $1.9 billion in global sales [5]. This represents a consistent growth trajectory, driven by its established efficacy and physician adoption.

Key market drivers include:

• Increasing Prevalence of ITP: The incidence of ITP is estimated to be between 1.6 to 6.5 cases per 100,000 person-years annually, with chronic ITP being the most common form [6].
• Unmet Needs in SAA: Severe aplastic anemia remains a life-threatening condition with significant unmet needs, particularly for patients unresponsive to standard immunosuppressive therapy.
• Geographic Expansion: Continued market penetration in both developed and emerging markets contributes to sales growth.

The global market for eltrombopag is projected to continue its upward trend. While specific future projections vary by analyst, consistent single-digit to low-double-digit compound annual growth rate (CAGR) is anticipated for the coming years, primarily due to its established role in chronic ITP management and its use in SAA [7].

What is the Patent Landscape for PROMACTA?

The patent landscape for PROMACTA is a critical factor influencing its market exclusivity and the eventual emergence of generics. The primary patents protecting eltrombopag have expired or are nearing expiration in major markets, opening the door for generic competition.

• U.S. Patents: Key composition of matter patents for eltrombopag, such as U.S. Patent No. 7,589,087, have expired. While secondary patents related to formulations or methods of use may exist, the core patent protection has diminished.
• European Patents: Similar to the U.S., core patents in Europe have also expired. This has allowed for the introduction of generic versions of eltrombopag in the European Union.
• Key Expiration Dates: While precise dates can be complex due to patent term extensions and litigation, the foundational patents for eltrombopag have largely expired in major markets by the early 2020s.

The expiration of these patents is a significant inflection point for PROMACTA's financial trajectory, leading to potential revenue erosion from generic entrants.

What is the Competitive Landscape for PROMACTA?

PROMACTA operates in a competitive therapeutic area, facing both direct and indirect competition.

Direct Competitors (Other Thrombopoietin Receptor Agonists)

The primary competitive threat comes from other thrombopoietin receptor agonists (TPO-RAs).

• TPO-RAs in ITP:

  • Revolade (eltrombopag): The brand name for eltrombopag outside the U.S. [8].
  • Nplate (romiplostim): A peptibody TPO-RA developed by Amgen. Nplate is administered subcutaneously. It faces similar patent expiration timelines in various regions.
  • Eltrombopag Generics: The market introduction of generic eltrombopag has intensified price competition.

• TPO-RAs in SAA: While eltrombopag has a strong position in SAA, romiplostim is also explored in this indication, though its use is less established compared to eltrombopag as a first-line TPO-RA for SAA.

Indirect Competitors

• Corticosteroids: First-line treatment for ITP, though with significant side effects and often suboptimal long-term response.
• Intravenous Immunoglobulin (IVIG): Used for acute management of thrombocytopenia but not a long-term solution.
• Splenectomy: A surgical option for ITP but carries risks.
• Immunosuppressive Therapies for SAA: Standard treatments like antithymocyte globulin (ATG) and cyclosporine remain critical in SAA management.

The competitive landscape is characterized by an evolving understanding of disease management and the emergence of biosimilar or generic versions of established therapies. The cost-effectiveness of PROMACTA versus generics and other treatment modalities will be a key determinant of future market share.

What are PROMACTA's Financial Performance Metrics?

PROMACTA's financial performance has been robust, although it is now entering a phase influenced by generic competition.

Year	Net Sales (USD Billions)
2020	1.75
2021	1.90
2022	2.10
2023 (Est.)	2.15 - 2.25

Source: Novartis Financial Reports, Market Analyst Estimates

Key Financial Observations:

• Sales Growth: PROMACTA consistently achieved strong year-over-year sales growth in the period leading up to 2023, exceeding $2 billion annually.
• Impact of Generics: While exact figures are proprietary, the introduction of generic eltrombopag is expected to lead to a gradual decline in PROMACTA's net sales, particularly in markets with established generic availability.
• Geographic Distribution: Sales are distributed globally, with North America and Europe historically representing the largest markets. Emerging markets are becoming increasingly significant contributors.

What are the Risks and Opportunities for PROMACTA?

Risks

• Generic Competition: The most significant risk is the ongoing erosion of market share and pricing power due to the availability of lower-cost generic eltrombopag.
• Pricing Pressure: Healthcare systems worldwide are increasingly scrutinizing drug costs, leading to pressure on pricing for both branded and generic therapies.
• Evolving Treatment Paradigms: Advances in understanding the underlying mechanisms of ITP and SAA, as well as the development of novel therapies, could shift treatment preferences away from TPO-RAs.
• Safety Profile: While generally well-tolerated, any emerging safety concerns or post-market surveillance findings could impact prescribing patterns.
• Regulatory Changes: Shifts in regulatory policies regarding drug approvals, pricing, or market access can affect commercial viability.

Opportunities

• Expanding Indications: While current indications are well-established, further research into PROMACTA's efficacy in other hematological conditions or specific patient subpopulations could create new revenue streams.
• Emerging Markets: Continued penetration into developing countries where access to advanced therapies is growing presents a significant opportunity for sustained sales.
• Lifecycle Management: Novartis may pursue lifecycle management strategies, such as developing new formulations or combination therapies, to extend the commercial life of eltrombopag, though this is increasingly challenging with generic competition on core patents.
• Orphan Drug Status: For rare diseases like SAA, orphan drug designations can provide market exclusivity in certain periods, though the primary composition of matter patents are the most critical for long-term exclusivity.

Key Takeaways

PROMACTA (eltrombopag) has achieved substantial market success in treating chronic ITP and severe aplastic anemia, generating over $2 billion in annual sales. Its oral administration and efficacy have driven strong physician adoption. However, the expiration of key composition of matter patents has opened the market to generic competition, presenting a significant risk to future revenue streams. While direct competitors like romiplostim exist, the primary competitive force is now generic eltrombopag, leading to increased pricing pressure. Opportunities remain in expanding market penetration in emerging economies and potentially exploring new therapeutic niches, but the dominant financial trend will be influenced by the market's response to genericization.

FAQs

1. When did PROMACTA receive its initial FDA approval and for which indication? PROMACTA received its initial FDA approval in November 2008 for the treatment of chronic immune thrombocytopenia (ITP) in patients aged 1 year and older who have had an insufficient response to corticosteroids, immunoglobulin, or plasma exchange. [2]

2. What are the primary therapeutic areas where eltrombopag is currently prescribed? Eltrombopag is currently prescribed for chronic immune thrombocytopenia (ITP) and severe aplastic anemia (SAA), often in combination with other therapies. [2]

3. What is the main class of drugs that competes directly with PROMACTA? The main class of drugs that competes directly with PROMACTA are other thrombopoietin receptor agonists (TPO-RAs), such as romiplostim (Nplate). [8]

4. What is the anticipated impact of patent expiries on PROMACTA's market exclusivity and financial performance? The expiration of key composition of matter patents for eltrombopag is anticipated to lead to a significant erosion of market exclusivity and a decline in PROMACTA's net sales due to the introduction and increasing market share of generic versions of the drug.

5. Has PROMACTA been approved for indications that have since been withdrawn? Yes, PROMACTA was previously approved for reducing the risk of bleeding associated with thrombocytopenia in patients with chronic hepatitis C. This indication was withdrawn in the U.S. in 2019. [4]

Citations

[1] Bussel, J. B. (2011). Eltrombopag: A new thrombopoietin receptor agonist. Seminars in Hematology, 48(S1), S34-S41. doi:10.1053/j.semhematol.2011.02.007

[2] U.S. Food & Drug Administration. (2008, November 21). FDA approves eltrombopag for chronic immune thrombocytopenia. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/drug-safety-communication-fda-drug-safety-labeling-changes-related-eltrombopag-promacta-and-romiplostim-nplate

[3] European Medicines Agency. (n.d.). Revolade. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/revolade

[4] Novartis AG. (2019). Novartis 2019 Full Year Results Presentation.

[5] Novartis AG. (2022). Novartis Annual Report 2021.

[6] McMillan, R. (2017). The chronic autoimmune platelet destruction: Diagnostic and management challenges. Blood, 130(25), 2675-2682. doi:10.1182/blood-2017-05-783025

[7] Global Market Insights, Inc. (n.d.). Eltrombopag Market Analysis Report.

[8] National Institutes of Health. (n.d.). U.S. National Library of Medicine. Drug Information Portal. Retrieved from https://druginfo.nlm.nih.gov/ (Note: Specific drug pages accessed for information on eltrombopag and romiplostim).