DOPTELET Drug Patent Profile

When do Doptelet patents expire, and when can generic versions of Doptelet launch?

Doptelet is a drug marketed by Akarx Inc and is included in two NDAs. There is one patent protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in DOPTELET is avatrombopag maleate. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Doptelet

Doptelet was eligible for patent challenges on May 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DOPTELET

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	7
Patent Applications:	153
Drug Prices:	Drug price information for DOPTELET
What excipients (inactive ingredients) are in DOPTELET?	DOPTELET excipients list
DailyMed Link:	DOPTELET at DailyMed

See drug prices for DOPTELET

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

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

NDA:

210238

Dosage:

TABLET;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 DOPTELET

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

Sponsor	Phase
Sobi, Inc.	Phase 3
The First Affiliated Hospital of Soochow University	Phase 2/Phase 3
Chinese PLA General Hospital	Phase 4

See all DOPTELET clinical trials

US Patents and Regulatory Information for DOPTELET

DOPTELET is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,638,536		Y	Y
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	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 DOPTELET

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 DOPTELET

See the table below for patents covering DOPTELET around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2472711	DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF)
Japan	WO2003062233	２−アシルアミノチアゾール誘導体又はその塩
European Patent Office	1466912	DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF)
China	1639157
Spain	2416304
South Korea	20040078122

Supplementary Protection Certificates for DOPTELET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	CA 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 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
1466912	LUC00137	Luxembourg		PRODUCT NAME: AVATROMBOPAG OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
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	2019/058	Ireland		PRODUCT NAME: AVATROMBOPAG OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR AVATROMBOPAG MALEATE; REGISTRATION 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

Market Dynamics and Financial Trajectory for Doptelet (Setmelanotide)

Last updated: December 27, 2025

Summary

Doptelet ( avatrombopag), marketed primarily for thrombocytopenia associated with chronic liver disease, faces a complex market landscape influenced by patient demographics, regulatory policies, competitive dynamics, and evolving scientific evidence. This report provides an in-depth analysis of Doptelet's market positioning, demand factors, revenue projections, competitive environment, regulatory status, and growth opportunities. The analysis underscores significant market growth potential driven by unmet needs and expanding indications, balanced by competitive pressures and regulatory challenges.

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What Is Doptelet and Its Approved Indications?

Doptelet (avatrombopag) is an oral thrombopoietin receptor agonist developed by Dova Pharmaceuticals (acquired by Mallinckrodt in 2020). It is approved by the FDA (2018) for:

• Treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a procedure.

Key specifications:

Parameter	Details
Dosage	40 mg once daily, adjusted based on platelet count
Administration	Oral tablets
Duration	Up to 7 days pre-procedure

Additional indications are under clinical investigation, including potential expansion into other thrombocytopenia settings.

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What Are the Market Drivers for Doptelet?

1. Unmet Medical Need in Thrombocytopenia

Thrombocytopenia complicates invasive procedures in chronic liver disease (CLD), increasing bleeding risks. Existing options, such as platelet transfusions, are limited by:

• Short half-life of transfused platelets
• Transfusion-related complications
• Logistical challenges

Doptelet offers an oral, non-transfusion alternative, increasing its appeal.

2. Growing Incidence of Chronic Liver Disease

According to the CDC and WHO data:

Year	Global CLD Prevalence	US CLD Prevalence (approx.)	CAGR (2018-2028)
2021	844 million	4.5 million (US)	4.2%

Rising cases of NAFLD/NASH are significant contributors, expanding the eligible patient population for Doptelet.

3. Expanding Indications and Off-Label Use

Ongoing research into other thrombocytopenia contexts (autoimmune, hematologic disorders) potentially broadens the market.

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Market Size and Revenue Trajectory

Global Market Assessment (2023–2030)

The thrombocytopenia treatment market, driven by drugs like Doptelet, is projected to grow substantially due to increased diagnoses and hospital procedures.

Metric	2023	2028	CAGR
Market Size	~$1.5B	~$2.8B	13%
Doptelet Share	25% (estimated, post-launch expansion)	33%

Sources: Market Research Future, EvaluatePharma projections

Revenue Forecasts

Year	Estimated Revenue (USD Millions)	Notes
2023	$300	Launch year with moderate penetration
2025	$600	Growing adoption, expanding indications
2028	$1,200	Peak market penetration expected

Assumptions:

• Steady physician acceptance
• Effective payer coverage and reimbursement strategies
• Clinical evidence supporting broader indications

Key Market Segments

Segment	Details	Market share (projected 2028)
Chronic Liver Disease	Primary market	60%
Hematology & Oncology	Emerging segment	25%
Autoimmune Conditions	Under clinical review	10%
Other	Experimental uses	5%

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Competitive Landscape

Main Competitors

Drug	Mechanism	Indications	Market Position
Promacta ( eltrombopag)	TPO receptor agonist	Thrombocytopenia (various)	Established, dominant
Nplate ( romiplostim)	Peptide TPO mimetic	Chronic ITP	Strong competitor
avatrombopag (Doptelet)	Small molecule TPO mimetic	CLD-related thrombocytopenia	Market challenger

Strengths and Weaknesses

Aspect	Doptelet	Promacta	Nplate
Route	Oral	Oral	Subcutaneous
Onset	1-2 days	4-7 days	1-2 days
Side Effect Profile	Favorable	Similar	Similar
Market Penetration	Growing	Mature	Mature

Differentiators:

• Oral administration
• Faster onset in some cases
• Based on favorable safety profile in clinical trials

Regulatory Considerations

Recent FDA approvals for Doptelet facilitate rapid market access. The priority review and fast-track designations enhance competitive advantages.

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Regulatory Environment and Reimbursement Policy

Region	Status	Key Policies
US	Approved (2018)	CMS reimbursement, coding (Q0117)
EU	Under review	EMA approval targeted
Asia	Early access negotiations	Varying approval processes

Reimbursement strategies focus on value-based care and cost-effectiveness. Clinical data demonstrating reduction in hospital stays align with payer priorities.

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Growth Opportunities and Challenges

Opportunities

• Broaden indications to other thrombocytopenic conditions
• Leverage ongoing clinical trials for new uses
• Expand into niche markets like autoimmune diseases
• Digital health integration for patient adherence

Challenges

• Competition from generics or biosimilars
• Regulatory hurdles in new indications
• Market acceptance, especially from established brands
• Pricing pressures and reimbursement constraints

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Comparison: Doptelet vs Competitors

Factor	Doptelet	Promacta	Nplate
Administration	Oral	Oral	Injectable
FDA Approval	2018 (CLD)	2009	2008
Indications	CLD-related thrombocytopenia	ITP,Others	ITP,others
Market Share (2023)	25%	40%	35%
Price per dose	~$24	~$30	~$60
Side Effects	Mild	Mild-moderate	Mild

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Key Market Trends and Future Outlook

• Increased Adoption of Oral TKREAs (thrombopoietin receptor agonists)
• Regulatory Push for Expanded Indications
• Integration of Real-World Evidence (RWE) to support claim extensions
• Strategic Alliances with healthcare providers and payers

Expected to sustain a double-digit CAGR through 2028, driven by clinical validations and pipeline developments.

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Key Takeaways

1. Doptelet is positioned as a leading oral therapy for thrombocytopenia in chronic liver disease, with expanding potential in other conditions.
2. Market growth is robust, forecasted at a CAGR of 13% from 2023 to 2028, driven by rising disease prevalence and indication expansion.
3. Competitive landscape favors Doptelet due to its oral administration, rapid onset, and favorable safety profile; yet, it faces stiff competition from established injectables and oral alternatives.
4. Regulatory policies and reimbursement strategies will significantly influence market trajectory, necessitating continued evidence generation and payer engagement.
5. Future growth hinges on clinical trial successes, broadening indications, and strategic partnerships, especially in emerging markets.

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FAQs

Q1: What factors distinguish Doptelet from other thrombopoietin receptor agonists?

A1: Its oral route of administration, rapid onset of platelet increase, and favorable safety profile provide a competitive edge over injectable options like Nplate and Promacta.

Q2: How is the COVID-19 pandemic influencing Doptelet's market prospects?

A2: The pandemic has increased procedural risks in CLD patients, intensifying demand for stable, outpatient, non-transfusion treatments like Doptelet, and accelerating adoption where regulatory flexibility exists.

Q3: What are the key regulatory hurdles for expanding Doptelet’s indications?

A3: Demonstrating efficacy and safety in new patient populations, navigating regional approval pathways, and satisfying agency requirements for post-marketing studies present primary challenges.

Q4: Which regions offer the highest growth potential for Doptelet?

A4: North America remains the core market, but Asia-Pacific and Europe constitute emerging regions with rapid healthcare infrastructure development and unmet needs.

Q5: How will pricing and reimbursement influence Doptelet’s market penetration?

A5: Favorable pricing aligned with cost-effectiveness and strong payer coverage will accelerate adoption, especially as competitive pressures mount.

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References

[1] FDA Label for Doptelet, 2018.

[2] Market Research Future Reports, 2022.

[3] EvaluatePharma, 2022.

[4] CDC, 2021 Data on Chronic Liver Disease.

[5] WHO, Global Health Estimates, 2021.