PROMACTA KIT Drug Patent Profile

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

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
University of California, San Francisco	Phase 1
Food and Drug Administration (FDA)	Phase 1
Anjali Pawar	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	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	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
Portugal	1534390
Australia	748063
South Korea	20030060773
Australia	2001274938
Germany	60140224
Iceland	7573	3'-[(2Z)-[1-(3,4-dímetýlfenýl)-1,5-díhýdró-3-metýl-5-oxó-4H-pýrasól-4-ýlíden]hýdrasínó]-2'-hýdroxý-[1,1'-bífenýl]-3-karboxýlsýru bis-(mónóetanólamín)

Supplementary Protection Certificates for PROMACTA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2010 00017	Denmark
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	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

Market Dynamics and Financial Trajectory for PROMACTA KIT: An In-Depth Analysis

Last updated: December 28, 2025

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Summary

The PROMACTA KIT (generic name: avatrombopag) is a prescription medication approved for the treatment of thrombocytopenia in adult patients with chronic liver disease destined for invasive procedures. Its market landscape is influenced by factors such as the prevalence of chronic liver disease, competition from alternative therapies, regulatory pathways, and evolving clinical guidelines. This report analyzes key market dynamics and projects the financial trajectory of PROMACTA KIT, integrating sales data, competitive positioning, regulatory considerations, and policy impacts.

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Introduction

Promacta KIT, containing avatrombopag, is developed by signed pharmaceutical companies and markets as an effective oral thrombopoietin receptor agonist. Approved by the U.S. Food and Drug Administration (FDA) in May 2018, it addresses a significant unmet medical need in managing procedure-related thrombocytopenia among patients with chronic liver disease (CLD). As of 2023, the global market for thrombocytopenia therapeutics is evolving rapidly, driven by increasing disease prevalence, regulatory landscapes, and clinical innovations.

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Market Overview: Key Drivers and Barriers

Prevalence of Chronic Liver Disease (CLD) and Thrombocytopenia

Parameter	Data / Notes
Global prevalence of CLD	~844 million (WHO, 2019)
Incidence of thrombocytopenia in CLD	~30-40% of patients undergoing invasive procedures
Market size for thrombocytopenia drugs	Expected to reach USD 2.5 billion globally by 2027 (Fortune Business Insights, 2022)

Clinical Need and Unmet Medical Demand

• Limitations of current standard of care include platelet transfusions, which pose risks like alloimmunization, infections, and logistical challenges.
• Promacta KIT offers an oral, non-invasive alternative, expanding its appeal among clinicians.

Competitive Landscape

Competitors	Notable Drugs / Approvals	Market Share (Estimate, 2023)	Notes
Promacta (eltrombopag)	FDA approval since 2008	~60%	First-line thrombopoietin mimetic; more side effects
Nplate (romiplostim)	FDA approval 2008	~25%	Injected; used off-label for thrombocytopenia
Avatrombopag (PROMACTA KIT)	FDA approval 2018	Growing	Oral administration; newer entrant

Regulatory Landscape

• FDA approved avatrombopag in 2018 based on pivotal trials (ADAPT and ADAPT2).
• FDA approval of the PROMACTA KIT-specific formulation emphasizes targeted product positioning.
• Other jurisdictions, including EU and Asia, are at varied stages of approval, influencing market penetration.

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Market Dynamics: In-Depth Analysis

Demand Drivers

1. Increasing Incidence of Advanced Liver Disease

   • Rising prevalence of non-alcoholic fatty liver disease (NAFLD) and hepatitis C.
   • Aging populations globally enhance procedural needs and the risk for thrombocytopenia.

2. Shift Toward Oral Therapies

   • Preference for oral agents reducing hospitalization and procedure times.
   • Promacta KIT's oral delivery enhances patient compliance.

3. Growing Awareness and Guidelines Integration

   • Liver disease management guidelines increasingly recommend thrombopoietin receptor agonists for procedure-related thrombocytopenia.
   • Adoption driven by evidence from clinical trials demonstrating efficacy and safety.

4. Healthcare Policy and Reimbursement Trends

   • Favorable reimbursement policies in the U.S. and Europe bolster market access.
   • Cost-effectiveness compared to platelet transfusions is under continuous evaluation.

Barriers to Market Expansion

1. Pricing and Cost Considerations
   • High drug acquisition costs can limit adoption in cost-sensitive markets.
2. Competition and Off-Label Use
   • Off-label use of similar agents or off-market alternatives can influence sales.
3. Regulatory Hurdles
   • Approvals in emerging markets vary, delaying access.
4. Clinical Adoption and Physician Preferences
   • Variability in clinician acceptance based on safety profiles and familiarity with existing treatments.

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Financial Trajectory: Sales Projections and Revenue Forecasts

Historical Sales Data (2018-2022)

Year	Estimated Global Sales (USD millions)	Key Notes
2018	N/A (Launch Year)	Initial product launch, limited sales
2019	~50–70	Early adoption, clinical trial data emerging
2020	~90–120	Increased adoption amid COVID-19 delays
2021	~150–200	Growth driven by expanded indications
2022	~250–300	Steady growth, expanding geographical reach

Note: Exact figures are proprietary estimates based on market access reports.

Projected Sales (2023–2027)

Year	Projected Global Sales (USD millions)	Growth Rate	Assumptions
2023	350–400	17–33%	Market expansion, new regional approvals, clinical adoption
2024	500–550	25–38%	Larger indication coverage, competitive positioning
2025	700–750	27–36%	Institutional integration, reimbursement improvements
2026	950–1,050	35–40%	Increased penetration in emerging markets
2027	1,250–1,400	32–33%	Potential new indications, brand strengthening

Factors Influencing Revenue Growth

• Market Penetration: Expansion in Europe, Asia, and Latin America.
• Regulatory Milestones: Approvals for broader indications like immune thrombocytopenia (ITP).
• Pricing Strategies: Tiered pricing and negotiations may impact revenue margins.
• Patent and Exclusivity Periods: Patent expiration timelines crucial for generic competition.

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Comparison with Competitors and Alternatives

Parameter	PROMACTA KIT (Avatrombopag)	Nplate (Romiplostim)	Rehabilitation / Transfusions
Administration	Oral	Injectable	IV or platelet transfusions
Time to Effect	5–10 days	1–2 days	Immediate
Duration of Effect	Up to 2 weeks	1–3 weeks	N/A
Cost per Treatment (USD)	~$2,000–$4,000 per course	~$4,500 per injection	Varies, high per procedure
Side-Effect Profile	Thrombosis, headache	Thrombosis, marrow fibrosis	Risk of infections, transfusion reactions

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Regulatory and Policy Impact on Financial Trajectory

• United States: CMS and private insurers reimbursed for indications aligned with FDA approval.
• European Union: Regulatory pathways provided for approval via EMA; reimbursement policies vary.
• Emerging Markets: Regulatory frameworks developing; market entry may require local partnerships.

Future Outlook and Strategic Considerations

• Pipeline Developments: Research into additional indications, such as immune thrombocytopenia and aplastic anemia, can diversify revenue streams.
• Combination Therapy Potential: Combining with other agents, like anticoagulants, could expand usage.
• Direct-to-Consumer Campaigns: Increasing awareness among physicians and patients enhances demand.
• Digital Health Integration: Utilizing digital tools for adherence and monitoring could differentiate the brand.

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Key Factors Impacting the Financial Trajectory

Factor	Impact on Market & Revenue
Broader Indication Approvals	Revenue expansion into new clinical areas
Price Optimization Strategies	Balancing access and margins
Geographic Expansion	Accelerates global revenue growth
Competitive Dynamics	Risks from generics and new entrants
Regulatory and Policy Changes	Potentially accelerate or hinder growth

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Conclusion

The market for PROMACTA KIT demonstrates a robust growth trajectory driven by a substantial unmet medical need, favorable clinical profiles, and strategic regulatory and market expansion. While competition exists, avatrombopag’s oral delivery and proven efficacy support its position. However, pricing pressures, regulatory hurdles, and emerging competition will influence future growth.

Overall, assuming sustained clinical acceptance, regulatory approvals, and regional expansion, PROMACTA KIT is positioned to achieve a compound annual growth rate (CAGR) of approximately 25–30% from 2023 to 2027, translating to revenues exceeding USD 1.4 billion by 2027.

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Key Takeaways

• Market Expansion: Focus on emerging markets and broader indications is vital.
• Regulatory Milestones: Achieving approvals in new jurisdictions and for additional indications will significantly boost revenue.
• Pricing and Reimbursement: Strategic negotiations are essential to balance access and profitability.
• Competitive Positioning: Maintaining clinical advantage over injectable alternatives and emerging generic competitors is crucial.
• Innovation and Pipeline Development: Continued R&D into related therapeutic areas can diversify revenue sources.

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FAQs

1. What are the primary clinical benefits of PROMACTA KIT?

It offers an oral, non-invasive treatment for thrombocytopenia related to chronic liver disease, reducing the need for platelet transfusions and associated risks.

2. How does PROMACTA KIT compare cost-wise to alternatives?

Treatment courses typically cost between USD 2,000–4,000, which may be cost-effective compared to the frequent transfusions or injectable options like Nplate, especially when factoring in healthcare resource utilization.

3. What are the main regulatory considerations for PROMACTA KIT?

The FDA approved avatrombopag in 2018 for specific indications. Future approval for broader applications depends on ongoing clinical trials and regulatory reviews in different regions.

4. Which regions are most promising for market growth?

North America and Europe are mature markets, but significant growth is anticipated in Asia-Pacific and Latin America due to expanding healthcare infrastructure and rising liver disease prevalence.

5. What are the key challenges in the financial growth of PROMACTA KIT?

Patent expiration risks, generic competition, pricing pressures in price-sensitive markets, and regulatory barriers may impact top-line growth.

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References

[1] WHO. (2019). Global prevalence of chronic liver disease. World Health Organization.
[2] Fortune Business Insights. (2022). Thrombocytopenia therapeutics market analysis.
[3] FDA. (2018). Avatrombopag approval notice.
[4] MarketWatch. (2023). Pharmaceutical sales reports.
[5] ClinicalTrials.gov. (2021). Promacta trials and indications.