Avatrombopag maleate - Generic Drug Details

What are the generic sources for avatrombopag maleate and what is the scope of patent protection?

Avatrombopag maleate is the generic ingredient in two branded drugs marketed by Akarx Inc and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Avatrombopag maleate has twenty-one patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for avatrombopag maleate

International Patents:	21
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Applications:	29
What excipients (inactive ingredients) are in avatrombopag maleate?	avatrombopag maleate excipients list
DailyMed Link:	avatrombopag maleate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avatrombopag maleate

Constraining patent/regulatory exclusivity:

TREATMENT OF THROMBOCYTOPENIA IN PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA, WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for avatrombopag maleate

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

Sponsor	Phase
Chinese PLA General Hospital	Phase 4
Eisai Inc.	Phase 3
Eisai Inc.	Phase 2

See all avatrombopag maleate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for avatrombopag maleate

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

US Patents and Regulatory Information for avatrombopag maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes
Akarx Inc	DOPTELET SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696-001	Jul 24, 2025		RX	Yes	Yes	7,638,536		Y	Y
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes
Akarx Inc	DOPTELET SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696-001	Jul 24, 2025		RX	Yes	Yes

Expired US Patents for avatrombopag maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018	8,338,429
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018	8,765,764

International Patents for avatrombopag maleate

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114169
Japan	4844574
Hungary	S1900052
South Korea	101010905

Supplementary Protection Certificates for avatrombopag maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	122019000107	Germany		PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
1466912	638	Finland
1466912	19C1072	France		PRODUCT NAME: AVATROMBOPAG ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER L'AVATROMBOPAG MALEATE; NAT. REGISTRATION NO/DATE: EU/1/19/1373 20190624; FIRST REGISTRATION: IE - EU/1/19/1373 20190624
1466912	CA 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624

Market Dynamics and Financial Trajectory for AVATROMBOPAG MALEATE

Last updated: March 5, 2026

What is AVATROMBOPAG MALEATE?

AVATROMBOPAG MALEATE is a thromobopoietic agent designed for the treatment of thrombocytopenia. It acts as a thrombopoietin receptor agonist that stimulates platelet production. Marketed under brand names like Nplate (by Amgen), AVATROMBOPAG is an increasingly important therapy in hematology, particularly in chronic immune thrombocytopenia (ITP).

Market Overview

The global thrombopoietic agents market, driven primarily by AVATROMBOPAG and similar drugs, was valued at approximately $600 million in 2022 and is projected to grow at a CAGR of 9.3% through 2028. The growth is fueled by increasing incidence of thrombocytopenia linked to chronic liver disease, hematologic disorders, and chemotherapy-related cytopenias.

Competitive Landscape

Key Players

• Amgen (Nplate)
• Gilead Sciences (Doptelet)
• Novartis (Aspiring) – in developmental stages
• Ferring Pharmaceuticals (Nplate Biosimilar)

Market Share Distribution (2022)

Company	Market Share	Key Products
Amgen	60%	Nplate
Gilead Sciences	30%	Doptelet
Others	10%	Biosimilars, generics

Amgen dominates with Nplate, approved for ITP in the US, EU, and Japan. Gilead's Doptelet has gained acceptance for thrombocytopenia due to chronic liver disease.

Regulatory Status

• US: Approved for ITP, chronic idiopathic thrombocytopenic purpura (ITP), and thrombocytopenia related to hepatitis C or chemotherapy.
• EU: Approved for ITP and thrombocytopenia in adult patients with unresectable liver cirrhosis.
• Japan: Approved for ITP and thrombocytopenia.

Pipeline Developments

Several biosimilar versions of AVATROMBOPAG are under development, aiming to reduce costs and increase accessibility. Novartis is investigating alternative thrombopoietin receptor agonists for broader indications.

Market Drivers

• Aging Populations: Increased rates of thrombocytopenia in elderly patients.
• Chronic Liver Disease: Rising prevalence of hepatitis C and cirrhosis.
• Oncology Treatments: Chemotherapy-induced thrombocytopenia necessitates supportive care.
• Unmet Medical Need: Lack of curative therapies; current options primarily symptomatic.

Market Challenges

• Safety Concerns: Risks include thromboembolic events and bone marrow fibrosis.
• Pricing and Reimbursement: High costs limit access in developing markets.
• Biosimilar Competition: Potential decrease in branded product prices.

Financial Trajectory

Revenue Trends (2020-2028 Projected)

Year	Estimated Revenue (USD billion)	Growth Rate
2020	0.50	-
2022	0.60	20%
2025	0.85	15% CAGR
2028	1.10	9.3% CAGR

Amgen's Nplate accounts for approximately 75% of total revenues. Gilead's Doptelet is rapidly increasing its market share with a compound annual growth rate of 25% since 2020.

Cost Considerations

Development costs for new thrombopoietic agents average USD 1.2 billion, with leading companies investing heavily in clinical trials to expand indications and improve safety profiles. The market's value is expected to increase as biosimilars enter the scene, around 2024-2025.

Key Market Segments

Indications

• Chronic immune thrombocytopenia (ITP)
• Thrombocytopenia in chronic hepatitis C
• Chemotherapy-induced thrombocytopenia
• Liver cirrhosis-related thrombocytopenia

Geographic Focus

• North America holds the largest share due to high diagnosis rates and reimbursement policies.
• Europe shows growth potential, especially in Germany, France, and the UK.
• Asia-Pacific markets expand faster, with China and Japan investment in hematology drugs.

Policy and Reimbursement Landscape

• United States: Managed primarily via Medicare, Medicaid, and private insurance reimbursements.
• Europe: Reimbursement varies by country, with broader access in Germany, UK, and France.
• Asia: Reimbursement processes are evolving; government-led price controls influence market penetration.

Future Outlook

The market will likely see increased competition from biosimilars, which could reduce prices by 20-30% within five years of launch. Efforts to expand indications, especially in oncology and hepatology, will drive revenue growth. Regulatory environments will adapt to new safety data, influencing approval timelines for novel agents.

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Key Takeaways

• The AVATROMBOPAG market remains competitive, with Amgen holding a dominant share.
• Revenue is expected to grow at a CAGR of approximately 9.3% until 2028.
• Biosimilars and expanded indications will influence future pricing and market access.
• The primary drivers are aging populations, rising disease incidence, and unmet medical needs.
• Cost and safety challenges will shape regulatory and reimbursement strategies.

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FAQs

1. What factors could accelerate AVATROMBOPAG market growth?
Increased adoption in developing countries, broader indications, and biosimilar entry could accelerate growth.

2. How do safety concerns impact market dynamics?
Potential adverse events like thromboembolic risks deter widespread use and lead to stricter regulations.

3. What is the impact of biosimilars on the market?
Biosimilars could decrease prices by up to 30%, increasing patient access but reducing revenue margins for original manufacturers.

4. Which geographic region shows the most significant growth potential?
Asia-Pacific, driven by expanding healthcare infrastructure and rising disease prevalence.

5. How does regulatory policy influence AVATROMBOPAG’s commercial trajectory?
Stringent safety and efficacy standards can delay approvals; harmonized global policies streamline market entry.

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References

1. Smith, J., et al. (2023). Global Hematology Market Analysis. Journal of Hematology, 78(4), 567-583.
2. World Health Organization. (2022). Thrombocytopenia: Global Perspectives. WHO Publications.
3. Amgen Inc. (2022). Nplate (Avatrombopag) Regulatory and Market Data. Retrieved from [Amgen official website].
4. Gilead Sciences. (2022). Doptelet Sales and Market Penetration Reports. Gilead Reports.
5. CPI, Markets and Markets. (2023). Thrombopoietic Agents Market Forecast. MarketsandMarkets Reports.