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
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	7,638,536		Y	Y

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
South Korea	101010905
Luxembourg	C00137
Netherlands	301020
Portugal	1466912
Denmark	1466912

Supplementary Protection Certificates for avatrombopag maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	341 50024-2019	Slovakia		PRODUCT NAME: AVATROMBOPAG VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/19/1373 20190624
1466912	CR 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, I SAERDELESHED AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912	1990057-0	Sweden		PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624
1466912	58/2019	Austria		PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE AVATROMBOPAGMALEAT; REGISTRATION NO/DATE: EU/1/19/1373 (MITTEILUNG) 20190624
1466912	132019000000157	Italy		PRODUCT NAME: AVATROMBOPAG O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE AVATROMBOPAG MALEATO(DOPTELET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1373, 20190624

Market Dynamics and Financial Trajectory for AVATROMBOPAG MALEATE

Last updated: July 27, 2025

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Introduction

Avatrombopag maleate is a thrombopoietin receptor agonist (TPO-RA) designed to elevate platelet counts in patients suffering from thrombocytopenia due to chronic liver disease or chemotherapy-induced platelet deficiency. Approved by the U.S. Food and Drug Administration (FDA) in 2018 (brand name: Doptelet), this oral agent has positioned itself within a competitive landscape of platelet-stimulating therapies. Analyzing its market dynamics and projected financial trajectory reveals critical insights for stakeholders across pharmaceutical R&D, healthcare providers, and investors.

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Market Overview and Therapeutic Indications

Primary Indications and Patient Demographics
Avatrombopag primarily treats thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled for a procedure and in those undergoing chemotherapy for solid tumors or hematologic malignancies. The prevalence of CLD worldwide exceeds 120 million individuals, with a significant subset requiring thrombocytopenia management before invasive procedures. Additionally, chemotherapy-induced thrombocytopenia affects a substantial proportion of cancer patients, further expanding potential market size.

Market Size Estimate
Global prevalence figures suggest approximately 15-20% of CLD patients develop clinically significant thrombocytopenia. In the U.S. alone, over 1 million patients annually are candidates for thrombocytopenia treatment prior to procedures, emphasizing a multi-billion dollar opportunity. Numerous existing therapies include eltrombopag (Promacta), romiplostim, and supportive platelet transfusions, with avatrombopag offering advantages in oral administration and potentially fewer adverse events.

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Market Dynamics

Competitive Landscape
Avatrombopag operates amid a competitive milieu comprising established TPO-RAs like eltrombopag and romiplostim. While romiplostim, administered via injection, has longstanding use, avatrombopag’s oral route enhances convenience and compliance, fostering its adoption. Its distinctive targeting mechanism and favorable side effect profile have bolstered its positioning.

Regulatory Environment
Regulatory approval in the U.S. has paved the way for commercialization, with other jurisdictions like Europe and Asia evaluating registration. The regulatory pathway remains crucial, as approval barriers fluctuate globally depending on safety data and local clinical trial outcomes.

Pricing and Reimbursement
Pricing strategies for avatrombopag influence its market penetration. Being a branded oral medication, it commands premium pricing relative to supportive care but may be offset by reduced hospitalization costs due to decreased need for platelet transfusions. Reimbursement frameworks across countries significantly affect patient access, with payer skepticism often limiting early adoption.

Manufacturing and Supply Chain Considerations
Manufacturers must ensure consistent supply chains and scalable production capabilities to meet global demand. The stability of raw materials, quality control, and compliance with Good Manufacturing Practices (GMP) are critical, especially amid ongoing geopolitical or logistical disruptions.

Market Penetration and Adoption Drivers
In markets with high awareness of thrombocytopenia complications, avatrombopag’s convenience and efficacy contribute to rapid clinician adoption. Educational initiatives about its safety profile and comparative benefits over transfusions bolster usage rates. Additionally, the advent of biosimilar or generic competitors after patent expiry (anticipated around 2030) could transform the competitive landscape.

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Financial Trajectory

Revenue Forecasts
In its initial years, avatrombopag’s revenues are projected to unfold as follows:

• 2018-2022: Launch phase with modest revenue growth, driven primarily by the U.S. market. Estimated sales hovered around $200–300 million annually, with significant uptake in specialized centers.

• 2023-2027: Expansion into international markets and increased clinician familiarity likely double revenues. Estimates suggest a compound annual growth rate (CAGR) of 15–20%, reaching approximately $800 million to $1 billion annually by 2027.

• Post-Patent Lifespan (2030+): Patent expiration may introduce generics, significantly lowering prices and compressing revenue streams unless brand differentiation persists through novel indications or combination therapies.

Research & Development Investment and Pipeline Influence
Increased R&D spend, especially on expanding indications, generation of new formulations, or combination treatments, can elevate long-term revenues. For example, ongoing trials investigating avatrombopag in immune thrombocytopenia (ITP) and other cytopenias could open additional markets.

Market Challenges and Risks
Key risks include pricing pressures, regulatory hurdles, eventually emerging generic competition, and the advent of alternative therapies. Moreover, safety concerns or real-world adverse event data could impact clinician confidence.

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Emerging Market Trends and Future Outlook

Personalized Medicine and Biomarker Integration
Advances in genomics and patient profiling will enhance avatrombopag’s targeting, maximizing efficacy and reducing adverse effects, thus improving market share.

Digital Health and Monitoring
Integration of digital monitoring tools for platelet counts and adverse events can streamline therapy management, contributing to patient adherence and market growth.

Global Expansion and Access
Affordability and health infrastructure development in emerging markets present opportunities for increased penetration, especially with tiered pricing models.

Regulatory and Policy Shifts
Adapting to changing healthcare policies favoring oral agents and outpatient procedures will underpin its growth prospects.

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Conclusion

The financial and market trajectory of avatrombopag maleate hinges on regulatory success, competitive positioning, and strategic expansion. Its advantages—oral administration, targeted efficacy, and a favorable safety profile—serve as significant growth catalysts within thrombocytopenia management. As global healthcare paradigms shift toward minimally invasive and outpatient procedures, avatrombopag’s footprint is poised for substantial expansion, assuming strategic market access and competitive mitigation.

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Key Takeaways

• Market Potential: The global thrombocytopenia treatment market is expansive, driven by high prevalence in chronic liver disease and oncology populations, positioning avatrombopag for significant growth.

• Competitive Edge: Its oral administration offers a distinct advantage over injectable TPO-RAs, fostering higher clinician and patient acceptance.

• Revenue Outlook: Estimated to reach approximately $1 billion annually by 2027 in the U.S. and select international markets, with growth propelled by market expansion and indication development.

• Risks & Challenges: Patent expiration, pricing pressures, regulatory hurdles, and competition necessitate strategic planning for sustained profitability.

• Future Directions: Incorporation into broader indications, personalization of therapy, and global market expansion will influence long-term financial success.

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FAQs

1. What are the primary clinical benefits of avatrombopag maleate over traditional therapy?
Avatrombopag’s oral formulation provides convenience, enabling outpatient management of thrombocytopenia without the need for injections or frequent hospitalizations, reducing procedural delays and improving patient compliance.

2. How does avatrombopag compare to other TPO receptor agonists in terms of safety and efficacy?
Clinical trials demonstrate avatrombopag’s comparable efficacy with a favorable safety profile, particularly with fewer hepatotoxic concerns compared to eltrombopag. Its lower risk of hepatotoxicity makes it suitable for patients with chronic liver disease.

3. What is the anticipated timeline for generic competition affecting avatrombopag?
Based on typical patent durations (~2030), generic competitors are unlikely before early 2030s, allowing for continued revenue growth in the short to mid-term.

4. Which markets are expected to drive future growth for avatrombopag?
Beyond North America, Europe, and Australia, emerging markets in Asia and Latin America are anticipated to be significant growth drivers, contingent on regulatory approvals and pricing strategies.

5. Are there ongoing clinical trials expanding avatrombopag’s indications?
Yes. Current studies are exploring its use in immune thrombocytopenia and other cytopenias. Positive outcomes could broaden its market scope and profitability significantly.

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Sources:

1. FDA Approves Doptelet (avatrombopag) for Thrombocytopenia in Chronic Liver Disease Patients—FDA. (2018).
2. Market Research Future. Global thrombocytopenia treatment market forecast. (2022).
3. ClinicalTrials.gov. Ongoing trials involving avatrombopag.
4. EvaluatePharma. 2023 Pharmaceutical Market Data.
5. Company Reports and Press Releases. (Santander Pharmaceuticals, 2018–2023).