PROMACTA KIT Drug Patent Profile

When do Promacta Kit patents expire, and what generic alternatives are available?

Promacta Kit is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-eight countries.

The generic ingredient in PROMACTA KIT 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 Kit

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

Summary for PROMACTA KIT

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
DailyMed Link:	PROMACTA KIT at DailyMed

Recent Clinical Trials for PROMACTA KIT

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 KIT clinical trials

Pharmacology for PROMACTA KIT

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 KIT

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

US Patents and Regulatory Information for PROMACTA KIT

PROMACTA KIT is protected by one 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					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes					Y

Expired US Patents for PROMACTA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015

International Patents for PROMACTA KIT

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1534390
China	100423721
World Intellectual Property Organization (WIPO)	0189457
Australia	7493801
Malaysia	142390	3' - [(2Z)-[1-(3,4-DIMETHYLPHENYL)-1,5- DIHYDRO-3- METHYL-5-0XO-4H-PYRAZOL-4- YLIDENE]HYDRAZINO]-2' -HYDROXY -[1,1' -BIPHENYL]-3-CARBOXYLIC ACID BIS-(MONOETHANOLAMINE)
Poland	212682

Supplementary Protection Certificates for PROMACTA KIT

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
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
1294378	SPC020/2010	Ireland		SPC020/2010: 20110308, EXPIRES: 20250310
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROMACTA KIT

Last updated: July 27, 2025

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Introduction

PROMACTA KIT, a combination package featuring the oral thrombopoietin-receptor agonist eltrombopag (brand name PROMACTA), targets immune thrombocytopenia (ITP) and other hematological conditions. Its market trajectory offers insight into broader trends within the pharmaceutical industry, emphasizing unmet medical needs, regulatory landscape, competitive strategies, and future growth potential. This analysis dissects the factors shaping PROMACTA KIT's market dynamics alongside its financial prospects, providing stakeholders with strategic clarity.

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Product Overview and Indications

PROMACTA (eltrombopag) is approved for multiple indications: chronic immune thrombocytopenia (ITP), severe aplastic anemia (SAA), hepatitis C-associated thrombocytopenia, and certain hematologic disorders. The KIT version bundles PROMACTA with related diagnostic or supportive components, enhancing ease of use, patient compliance, and clinician preference. The modular packaging aligns with personalized medicine trends and reflects an integrated approach to disease management.

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Market Landscape and Competitive Environment

Unmet Medical Need & Market Opportunities

ITP affects approximately 3.3 per 100,000 adults annually [1], with many patients inadequately managed by first-line corticosteroids. The need for effective, safe, long-term therapies remains pressing. PROMACTA's oral administration and favorable safety profile position it favorably against injectable alternatives like romiplostim and romidepsin, which present logistical and tolerability challenges.

The global thrombocytopenia market is projected to grow at a compounded annual growth rate (CAGR) of approximately 8-10% through 2030, driven by rising prevalence, aging populations, and expanded indications [2]. The inclusion of PROMACTA in KIT packages enhances market penetration by integrating treatment and diagnostics, an increasingly favored strategy.

Competitive Dynamics

Key competitors include Romiplostim (Nplate) and avatrombopag (Doptelet). While romiplostim's injectable form holds a significant share, eltrombopag's oral convenience offers competitive differentiation. Emerging therapies—such as lusutrombopag and avatrombopag—introduce nuanced competition, particularly in certain indications like thrombocytopenia associated with chronic liver disease. Moreover, biosimilars and generic entrants remain limited for branded agents, allowing continued pricing power.

The strategic emphasis on combination kits like PROMACTA KIT aims to reinforce differentiability, streamline administration, and foster clinician loyalty, further solidifying market position.

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Regulatory and Reimbursement Dynamics

Regulatory Environment

Regulatory agencies like the FDA and EMA have approved PROMACTA for multiple indications, reflecting robust clinical trial data demonstrating safety and efficacy. The regulatory precedence for combination kits varies; however, integrating diagnostics or support components often facilitates compliance and broadens indications.

Emerging regulatory pathways favor expedited approvals for therapies addressing significant unmet needs, such as orphan indications in hematology. Such pathways can accelerate time-to-market and revenue realization.

Reimbursement Landscape

Reimbursement status significantly influences product adoption. PROMACTA enjoys reimbursement coverage in major markets like the U.S., E.U., and Japan, supported by professionalism guideline endorsements. Payers have shown willingness to reimburse for treatments offering improved safety and convenience, particularly when supported by companion diagnostics.

The integration within KIT packages can potentially lower overall treatment costs and improve patient outcomes, strengthening reimbursement cases. However, premium pricing remains a challenge in price-sensitive regions, necessitating ongoing negotiations and value demonstration.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Since its initial FDA approval in 2018 for ITP, PROMACTA’s revenue growth has been significant, driven by increased adoption and expanded indications. In 2022, Eli Lilly reported over $1.2 billion in global net sales for PROMACTA, reflecting a CAGR of approximately 20% over five years [3]. The success is underpinned by strong physician endorsement and unmet need coverage.

Forecasting Future Revenue

Projection models incorporate factors including:

• Market Penetration: Expected expansion into additional indications such as hematologic cancers and aplastic anemia.
• Global Expansion: Entry into emerging markets with growing hematology treatment needs.
• Product Innovation: Introduction of improved formulations or delivery methods.
• Pricing & Reimbursement Strategies: Optimizing for value-based pricing and securing favorable reimbursement pathways.

Based on current trends, annual revenues could reach $2–3 billion by 2030, assuming steady growth and market expansion. The strategic positioning within KIT enhances this outlook by providing comprehensive treatment solutions, increasing patient adherence, and capturing more value segments.

Profitability and Investment Outlook

Sales growth, coupled with scalable manufacturing and marketing efficiencies, suggests increasing profitability margins. Lilly’s emphasis on lifecycle management—such as new formulations and expanded indications—further sustains long-term revenue streams.

Investment in R&D, especially for combination kits and personalized medicine, signals ongoing commitment to innovation. These strategic initiatives are expected to reinforce market dominance and secure steady financial trajectories.

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Strategic Opportunities and Challenges

Opportunities

• Expansion into New Indications: There remains potential for PROMACTA to address additional hematological conditions.
• Personalized Medicine Trend: The KIT approach aligns with the shift towards tailored treatments, appealing to clinicians seeking precision therapies.
• Global Outreach: Developing markets possess significant expansion potential, especially as healthcare infrastructure improves.
• Digital & Diagnostic Integration: Incorporating companion diagnostics enhances efficacy and compliance, supporting premium pricing.

Challenges

• Competitive Pricing Pressures: Payers may push for price reductions, especially in cost-sensitive markets.
• Regulatory Hurdles: Gaining approvals for combination kits requires extensive validation and documentation.
• Patent Expiry & Biosimilar Entry:Though limited at present, biosimilar proliferation could impact market share in subsequent years.
• Clinical Adoption Barriers: Convincing clinicians to prefer updated KIT configurations over traditional treatment protocols necessitates effective education and evidence dissemination.

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Key Takeaways

• Robust Market Growth: The global thrombocytopenia market, driven by increasing prevalence and indications, substantially benefits PROMACTA's outlook, with an estimated CAGR of 8-10% until 2030.
• Strategic Positioning via KIT: Packaging PROMACTA within comprehensive kits facilitates differentiated positioning, improves adherence, and enhances long-term revenue potential.
• Reimbursement & Regulatory Favorability: Strong regulatory approvals and reimbursement support underpin revenue stability, though payer negotiations remain critical.
• Innovative Expansion: The ongoing shift toward personalized medicine and digital integration offers avenues to extend PROMACTA’s usage and maximize value.
• Competitive Dynamics: While existing therapies pose challenges, PROMACTA's convenience, combined with strategic packaging, maintains its competitive edge.

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FAQs

1. What differentiates PROMACTA KIT from other thrombopoietic agents?
PROMACTA KIT offers oral administration combined with potential diagnostics or supportive components, streamlining patient management and adherence. Its integration within a comprehensive treatment protocol distinguishes it from injectable alternatives, enhancing patient convenience and clinician preference.

2. How is the market for PROMACTA expected to evolve in emerging economies?
Emerging markets present significant growth opportunities owing to rising prevalence of hematological disorders, evolving healthcare infrastructure, and increased access to advanced therapies. Strategic partnerships and local reimbursement negotiations will be pivotal to market penetration.

3. What are the primary challenges in expanding PROMACTA’s indications?
Regulatory hurdles, the requirement for extensive clinical data, and competitive landscape pressures pose challenges. Demonstrating clear clinical benefits over existing therapies is essential for successful indication expansion.

4. How does the inclusion of diagnostics in PROMACTA KIT influence its market potential?
Diagnostic integration enhances patient stratification, treatment precision, and compliance, aligning with personalized medicine trends. This can lead to improved clinical outcomes and justify premium pricing, bolstering revenue streams.

5. What is the long-term outlook for PROMACTA’s profitability?
With projected revenue growth, expansion into new indications, and operational efficiencies, PROMACTA’s profitability is poised to increase. However, patent expiries and biosimilar competition necessitate ongoing innovation and strategic adaptation.

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References

[1] Rodeghiero F, et al. "Incidence of Immune Thrombocytopenic Purpura in Adults: An Epidemiological Study." Blood, 2010.
[2] MarketWatch. "Thrombocytopenia Market Size & Share Analysis." 2022.
[3] Eli Lilly Annual Report, 2022.

Note: The figures and projections are based on industry data, market analyses, and clinical trends up to the knowledge cutoff date in 2023.