avatrombopag maleate - Profile

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.

Summary for avatrombopag maleate

International Patents:	21
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2

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.

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 SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696-001	Jul 24, 2025		RX	Yes	Yes			Y	Y
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			Y	Y
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		RX	Yes	Yes
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		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
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018

International Patents for avatrombopag maleate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03062233
Hungary	S1900052
Netherlands	301020
Canada	2472711	DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF)
Cyprus	1114169
Spain	2610611

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	638	Finland
1466912	CA 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912	122019000107	Germany		PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
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	C20190040 00310	Estonia		PRODUCT NAME: AVATROMBOPAAG;REG NO/DATE: EU/1/19/1373 24.06.2019

Investment Scenario, Market Dynamics, and Financial Trajectory for Avatrombopag Maleate

Last updated: February 3, 2026

Summary

Avatrombopag maleate is an oral, small-molecule thrombopoietin receptor agonist indicated primarily for thrombocytopenia associated with chronic liver disease (CLD) and chemotherapy-induced thrombocytopenia. Its marketed product, marketed as Doptelet by Innovent Biologics (in collaboration with Allergan), has captured a niche in hematology. As of 2023, the drug exhibits promising growth potential driven by expanding indications, competitive landscape shifts, and regulatory dynamics. This report evaluates its current market positioning, growth drivers, revenue potential, and investment outlook.

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What Is the Current Market Status for Avatrombopag Maleate?

Regulatory Approvals and Indications

Year	Approval Body	Indications	Marketed Name	Key Regions
2018	FDA (USA)	Thrombocytopenia in Chronic Liver Disease	Doptelet	US, Canada, some EU countries
2020	EMA	Same as FDA	Doptelet	EU markets
2021	Japan PMDA	Thrombocytopenia (additional indication)	Doptelet	Japan

Sales Data (Estimated)

Year	Revenue (USD millions)	Notes
2020	$120	Launch year, initial uptake
2021	$250	Expanded indications, increased prescriptions
2022	$350	Market penetration, regional expansion

Market Share and Competition

Competitor	Drugs / Candidates	Market Share (2022)	Key Features
Eltrombopag (Promacta)	Thrombopoietin receptor agonist	~60%	Oral, multiple indications
Romiplostim (Nplate)	Oligonucleotide mimetic	~30%	Injectable, primarily ITP
Avatrombopag	Newly marketed	~10%	Oral, fewer drug interactions

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Market Dynamics: Drivers and Barriers

Factors Driving Growth

• Expanding indications: Research is ongoing into avatrombopag's efficacy in immune thrombocytopenia (ITP), chemotherapy-induced thrombocytopenia, and other thrombocytopenia-related conditions.

• Regulatory approvals: Inclusion in multiple regions enhances accessible patient populations—US, EU, Japan.

• Mechanism advantage: Oral administration with a favorable safety profile enhances compliance, especially over injectable options like romiplostim.

• Pipeline developments: Early-stage research into combination therapies and new indications.

Market Barriers and Challenges

Barrier	Impact	Mitigation Strategies
Competition from established drugs	Pricing pressures, market share erosion	Differentiation via safety, expanded indications
Regulatory delays	Market entry delays	Proactive engagement with authorities
Patent expiries on competitors	Increased competition	Robust IP portfolio, lifecycle management

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Financial Trajectory: Revenue, Cost, and Profitability Outlook

Revenue Projections (2023–2028)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$400	Market expansion, ongoing adoption
2024	$550	Additional indications, increased physician awareness
2025	$700	Launch in emerging markets; clinical trial approvals
2026	$850	Broader indications, combination trials
2027	$1,050	Global penetration, pricing optimization
2028	$1,250	Sustained demand, pipeline contributions

Cost and Margin Dynamics

Expense Type	Approximate % of Revenue	Notes
R&D	15–20%	Continues for pipeline expansion
Sales & Marketing	20–25%	Geographic rollouts
Manufacturing & Distribution	10–15%	Scaling up with demand
Operating Margin	25–30%	Potentially improving with scale

Profitability Timeline

• Expected breakeven occurs by 2024–2025, driven by revenue growth and operational efficiencies.
• Margins expand through increased sales volume, optimized manufacturing, and patent protections.

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Investment Considerations

Opportunities

• High growth potential: Expanding indications, especially in ITP.
• Market differentiation: Favorable safety and administration profile.
• Pipeline pipeline: Investigational uses in hematological disorders and possibly oncology.

Risks

• Competitive landscape: Dominance of established agents and biosimilars.
• Regulatory hurdles: Stringent approval processes could delay expansion.
• Pricing pressures: Reimbursement policies might restrict revenue growth.

Valuation Metrics

Metric	2022 Data	Source
Market Cap	USD 3.8 billion	Company reports
P/E Ratio	25x (est.)	Industry average
Estimated 5-year CAGR	~20%	Analyst estimates

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Comparative Analysis with Similar Drugs

Aspect	Avatrombopag	Eltrombopag	Romiplostim
Administration	Oral	Oral	Injectable
Indications	CLD, (expanding)	ITP, others	ITP
Onset of Action	5–7 days	7–10 days	1–2 weeks
Safety Profile	Favorable	Moderate (hepatotoxicity risk)	Injection site reactions
Patent Status	Active	Expired (generics available)	Patent expiry approaching

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Future Growth Scenarios

Scenario	Likelihood	Key Drivers	Projected Revenue 2028 (USD millions)
Conservative	Moderate	Limited indication expansion	~$800
Realistic	High	Multiple new indications, market penetration	~$1,250
Optimistic	Low	Rapid approval and adoption	~$1,500+

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Regulatory and Policy Environment

• US FDA: Follows expedited review pathways for hematological drugs.
• EU EMA: Emphasizes risk-benefit in chronic conditions.
• Japan PMDA: Facilitates rapid approvals for innovative therapies.
• Reimbursement: Increasing coverage in EU, US, and Asian markets based on cost-effectiveness analyses.

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Key Takeaways

• Market Position: Avatrombopag maleate enjoys a growing niche in thrombocytopenia management, with a competitive edge via oral dosing and safety profile.
• Growth Drivers: Indication expansion, regional approvals, and pipeline progress are central to revenue outlook.
• Financial Trajectory: Expect revenues to more than double from current levels by 2028, supported by operational scalability and pipeline development.
• Risks: competes with well-established drugs like eltrombopag and romiplostim; patent expirations and pricing pressures could challenge profitability.
• Strategic Recommendations: Investors should monitor ongoing clinical trial results, regulatory updates, and market acceptance trends for a comprehensive valuation.

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FAQs

1. What are the primary indications currently approved for avatrombopag maleate?
Primarily thrombocytopenia associated with chronic liver disease and chemotherapy-induced thrombocytopenia, with ongoing research into additional indications such as immune thrombocytopenia (ITP).

2. How does avatrombopag compare to established agents like eltrombopag?
It is orally administered, with a potentially better safety profile and fewer drug-drug interactions, providing a competitive advantage in patient compliance and safety.

3. What are the main regulatory hurdles for avatrombopag’s future growth?
Approval for new indications, regional market access, and reimbursement policies represent significant hurdles that could influence its market penetration.

4. What is the revenue outlook for avatrombopag over the next five years?
Estimated to grow from approximately $400 million in 2023 to over $1.25 billion by 2028, driven by indication expansion and global market penetration.

5. How does patent protection influence the investment landscape for avatrombopag?
Patent protections secure exclusivity, enabling pricing power and revenue stability; impending patent expiries could invite generic competition, impacting profitability.

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References

1. FDA approval announcement (2018): US Food and Drug Administration. Doptelet (avatrombopag) approval for thrombocytopenia in chronic liver disease. FDA.gov
2. Market analysis (2022): IQVIA, "Global Hematology Market Report," 2022.
3. Pipeline updates: ClinicalTrials.gov, "Avatrombopag Indication Trials," 2023.
4. Company filings: Allergan’s annual reports, 2022.
5. Regulatory policies: EMA guideline on thrombopoietic agents, 2021.

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