PROMACTA Drug Patent Profile

When do Promacta patents expire, 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-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
Food and Drug Administration (FDA)	Phase 1
University of California, San Francisco	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					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012		DISCN	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011	AB	RX	Yes	No					Y

Expired US Patents for PROMACTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012

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
Hungary	0302257
World Intellectual Property Organization (WIPO)	9922732
Eurasian Patent Organization	201400387
South Korea	20030060773
Colombia	6260058

Supplementary Protection Certificates for PROMACTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	122010000037	Germany		PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/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
1534390	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
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
1534390	91 3-2010	Slovakia		PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315

Market Dynamics and Financial Trajectory for PROMACTA (Eltrombopag)

Last updated: December 29, 2025

Executive Summary

PROMACTA (eltrombopag) is an oral thrombopoietin receptor agonist developed by Genentech/Roche, initially approved in 2018 for treating severe aplastic anemia (SAA) and immune thrombocytopenia (ITP). Its broad indications and innovative mechanism position it for continued market expansion, driven by increasing prevalence of its target conditions, evolving treatment paradigms, and generics entry. This report assesses the current market landscape, financial forecasts, key drivers, competitors, and regulatory considerations influencing PROMACTA’s commercial trajectory through 2030.

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What is PROMACTA and How Does It Function in the Market?

PROMACTA (eltrombopag):

Attribute	Details
Therapeutic Class	Thrombopoietin receptor agonist
Indications

• Severe aplastic anemia (SAA)
• Chronic immune thrombocytopenia (ITP)
• Hepatitis C-associated thrombocytopenia (approved in select markets)
• Other rare thrombocytopenias |
  | Mechanism of Action | Stimulates megakaryocyte proliferation and differentiation, increasing platelet production |

Mechanism innovation offers advantages over biologics, including oral administration and favorable safety profiles, fostering high patient adherence and physician preference.

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Market Dynamics: Key Drivers and Challenges

What Are the Primary Market Drivers for PROMACTA?

1. Growing Prevalence of Target Diseases

Condition	Estimated Global Prevalence	Notes
ITP	~50,000 in US, 150,000 globally (chronic)	Increasing awareness and diagnosis; pediatric and adult populations
SAA	2-3 per million annually; rare but severe	Underdiagnosed in developing regions
Hep C-associated thrombocytopenia	Up to 15% of chronic HCV cases	Antiviral therapies improve outcomes, but thrombocytopenia remains a barrier

2. Expansion of Indications and Labeling

• FDA and EMA approvals have extended PROMACTA’s use to children, refractory cases, and secondary indications.
• Additional labels reinforce dependence on thrombopoietic agents.

3. Clinical Advancements and Formulations

• Favorable safety data and ease-of-use bolster real-world adoption.
• Ongoing trials evaluate PROMACTA in aplastic anemia (refractory cases), contributing to future label expansions.

4. Limited Competition due to Unique Mechanism

Competitors	Features	Market Position
Romiplostim (Nplate)	Injectable TPO mimetics	Market share; Less convenient than oral PROMACTA
Avatrombopag (Doptelet)	Oral TPO agonist	Competitive, with overlapping indications
Eltrombopag’s Edge	Oral, well-established safety profile	Stronger patient preference, especially in outpatient settings

What Challenges Could Impact PROMACTA’s Market Growth?

1. Generic Entry and Price Competition

• Patent expiry anticipated around 2023–2025, with generics poised to enter key markets.
• Price erosion and formulary exclusion could reduce margins.

2. Clinical Safety Concerns

• Potential risks of hepatotoxicity and thromboembolic events may limit long-term use.
• Regulatory reviews of safety signals (e.g., in China, or EMEA) could influence prescribing.

3. Regulatory and Reimbursement Barriers

• Variability in approval timelines and reimbursement policies, particularly in emerging markets.
• Cost-effectiveness thresholds influencing formulary decisions.

4. Emergence of Next-Generation Therapies

• Gene therapies and novel agents targeting underlying pathologies could disrupt demand.
• Future pipeline drugs with improved safety and efficacy may shift market shares.

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Financial Trajectory and Market Share Forecasts

Historical Sales Data and Current Market Position

Year	Global Sales (USD millions)	Notes
2017	~$200*	Launched globally; initial uptake
2018	~$410	Major approvals expand indications
2019	~$650	Market penetration increases
2020	~$820	COVID-19 impacted; overall growth
2021	~$950	Recovery and expanded approvals

(Source: EvaluatePharma, 2022 estimates)

Projected Sales and Market Penetration (2023–2030)

Year	Estimated Global Sales (USD Millions)	Growth Rate	Key Assumptions
2023	~$1.2 billion	26%	Patent cliff approaching; generic competition begins
2024	~$1.45 billion	21%	Increased off-label use, expanded approvals in Asia
2025	~$1.7 billion	17%	Patent expiry effects, market stabilization
2026	~$2.0 billion	18%	Market penetration with generics, new indications
2027	~$2.3 billion	15%	Continued growth in China, India
2028	~$2.5 billion	9%	Market maturity, emerging biosimilars
2029	~$2.6 billion	4%	Saturation in key markets
2030	~$2.75 billion	6%	Diverse geographic growth

Compound Annual Growth Rate (CAGR): From 2023 to 2030: ~15%

Regional Market Contributions

Region	Contribution (2022)	Growth Drivers	Challenges
North America	~50%	High prevalence, established reimbursement	Patent expiration looming
Europe	~25%	Stringent regulation, adoption	Reimbursement delays
Asia-Pacific	~15%	Growing healthcare access, unmet needs	Pricing, regulatory variability
Rest of World	~10%	Emerging markets, rare indications	Infrastructure, cost barriers

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Comparative Analysis with Peers and Alternatives

Drug	Type	Indications	Approval Year	Route	Pros	Cons
PROMACTA (eltrombopag)	Oral TPO agonist	ITP, SAA, others	2018	Oral	Oral, broad label, established safety	Expiring patent, generic threat
Nplate (romiplostim)	Injectable TPO mimetic	ITP, SAA	2011	SubQ	Proven efficacy	Injectable, less convenient
Doptelet (avatrombopag)	Oral TPO agonist	Thrombocytopenia	2018	Oral	Similar efficacy, approved in multiple markets	Market share contested

Implication: PROMACTA’s oral formulation provides a competitive advantage in outpatient management but faces imminent generic challenge.

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Regulatory Environment and Policy Impact

Market	Regulatory Status	Policies Affecting PROMACTA	Notable Developments
FDA (US)	Approved for ITP, SAA, others	Favorable for orphan drugs; biosimilar pathways active	Patent expiry expected 2023–2025
EMA (EU)	Similar approvals	Emphasis on safety monitoring	Post-authorization commitments ongoing
China (NMPA)	Approved since 2019	Price controls, reimbursement negotiations	Local manufacturing growth anticipated
Emerging Markets	Variable	Access limitations	Rapid approval pathways available

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Future Outlook and Strategic Considerations

Opportunities

• Label Expansion: Additional approvals in aplastic anemia, thrombocytopenia related to cancer, or hepatitis C.
• Combination Therapies: Synergies with immunomodulators and antivirals.
• Market Penetration in Asia and Latin America: Growing healthcare infrastructure.
• Biosimilar and Generic Competition Management: Early licensing and patent strategies.

Threats

• Patent Expiry & Generics: Potential 2023–2025 window could significantly impact pricing and sales.
• Emerging Therapies: Gene editing approaches (e.g., CRISPR-based solutions) could redefine treatment.
• Regulatory Scrutiny on Safety Risks: Could limit long-term usage.

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Key Takeaways

• Market momentum for PROMACTA remains robust through increasing prevalence of thrombocytopenic conditions and expanding indications.
• Financial forecasts project robust growth (CAGR ~15%) until 2030, but patent expiry and generic competition pose significant risks.
• Strategic focus should include early market share capture in emerging regions, proactive lifecycle management, and diversification of indications.
• Regulatory landscape favors innovation but demands ongoing safety monitoring and adaptation.
• Competitive advantage hinges on oral administration, safety profile, and flexible dosing options.

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Frequently Asked Questions (FAQs)

1. When is PROMACTA’s patent set to expire, and how will it impact sales?
Patent protection is expected to expire around 2023–2025, with subsequent generic entry likely to reduce prices and sales margins in mature markets.

2. Which regions offer the greatest growth opportunities for PROMACTA?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa present significant growth opportunities due to increasing healthcare access and unmet needs.

3. How does PROMACTA compare to its primary competitor, Nplate?
PROMACTA’s oral route offers convenience over Nplate's injectable form, but Nplate retains market share through established efficacy and safety. Post-patent, market share may shift toward biosimilars.

4. What are the main safety concerns associated with PROMACTA?
Risks include hepatotoxicity and thromboembolic events; ongoing safety surveillance influences regulatory recommendations and prescribing.

5. Are there pipeline developments that could influence PROMACTA’s future?
Yes, ongoing trials for aplastic anemia, and potential combination therapies, aim to expand its portfolio, although competition from gene therapies is emerging.

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References

[1] EvaluatePharma. (2022). World Preview 2022: Outlook to 2026.
[2] Roche Reports. (2021). Annual Financial Statements.
[3] U.S. Food & Drug Administration. (2018). FDA Approval of PROMACTA.
[4] European Medicines Agency. (2019). Marketing Authorization for PROMACTA.
[5] Chinese NMPA. (2019). Regulatory Approval for Eltrombopag.