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
Japan	WO2003062233	２−アシルアミノチアゾール誘導体又はその塩
South Korea	20040078122
European Patent Office	2314586	Dérivé 2-acylaminothiazole ou sel de celui-ci (2-Acylaminothiazole derivative or salt thereof)
China	1319967
China	1639157
Japan	2008111001	2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF

Supplementary Protection Certificates for DOPTELET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	C201930073	Spain		PRODUCT NAME: AVATROMBOPAG O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR MALEATO DE AVATROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/19/1373; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1373; DATE OF FIRST AUTHORISATION IN EEA: 20190620
1466912	301020	Netherlands		PRODUCT NAME: AVATROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER AVATROMBOPAG-MALEAAT; REGISTRATION NO/DATE: 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	SPC/GB19/071	United Kingdom		PRODUCT NAME: AVATROMBOPAG MALEATE; REGISTERED: UK EU/1/19/1373/001-002 20190624; UK EXTRA MA'S ON IPSUM 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	CR 2019 00057	Denmark		PRODUCT NAME: AVATROMBOPAG ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, I SAERDELESHED AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624

Market Dynamics and Financial Trajectory for DOPTELET (Avatrombopag)

Last updated: July 27, 2025

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Introduction

DOPTELET (avatrombopag) is an oral thrombopoietin receptor agonist developed by RAPPTOR PHARMACEUTICALS. Approved by the U.S. Food and Drug Administration (FDA) in May 2018 for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a procedure, DOPTELET represents a significant advancement within hematological therapeutics. Its market trajectory hinges on evolving clinical protocols, competitive landscape, regulatory decisions, and healthcare economics.

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Market Landscape and Key Drivers

1. Therapeutic Need and Patient Population

Thrombocytopenia—a condition characterized by low platelet counts—is prevalent among patients with chronic liver disease, especially cirrhosis. These patients are at heightened risk of bleeding complications during invasive procedures [2]. Traditionally, platelet transfusions served as the primary intervention, bearing risks such as alloimmunization, infections, and logistical complications. The unmet clinical need for a safe, effective, and easy-to-administer alternative fuels demand for DOPTELET.

Estimates indicate that approximately 1.5 million patients with CLD in the U.S. could be candidates for thrombocytopenia management. The growing prevalence of liver diseases, attributed to factors like non-alcoholic fatty liver disease (NAFLD) and hepatitis C, sustains a steady demand trajectory [3].

2. Market Penetration and Utilization Trends

Since its FDA approval, DOPTELET has been incorporated into clinical guidelines for medullary- and procedure-related thrombocytopenia. Its ease of oral administration enhances adoption over intravenous agents like eltrombopag or romiplostim, which require clinic visits and carry distinct safety profiles.

In 2022, sales figures indicated incremental market penetration, with initial uptake concentrated within specialized centers. The COVID-19 pandemic posed temporary barriers to clinical adoption but did not significantly alter the underlying growth potential.

3. Competitive Dynamics

DOPTELET faces competition primarily from existing thrombopoietin receptor agonists:

• Eltrombopag (Promacta): Approved for chronic immune thrombocytopenia (ITP), with off-label use in CLD, but associated with hepatotoxicity risks.
• Romiplostim (Nplate): Injectable agent with established efficacy but logistical drawbacks.

Emerging therapies and biosimilars could influence market share. However, DOPTELET’s oral route and a favorable safety profile provide a competitive edge, especially in peri-procedural settings.

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Regulatory and Clinical Development Factors

1. Expanded Indications

Ongoing trials assess DOPTELET’s efficacy in other thrombocytopenia contexts, including:

• Chronic immune thrombocytopenia (ITP)
• Aplastic anemia

Positive trial outcomes could expand its markets beyond CLD, substantially elevating revenue potential [4].

2. Regulatory Landscape

While FDA approval is current for thrombocytopenia associated with CLD, regulatory pathways in Europe and Asia remain under consideration. Approval timelines and reimbursement policies significantly influence the product's market access and financial performance.

3. Safety Profile and Post-Marketing Surveillance

DOPTELET’s safety profile, characterized by low risk of thrombotic events and hepatotoxicity, enhances clinician confidence. Robust pharmacovigilance and real-world data further solidify its market standing.

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Financial Trajectory and Revenue Projections

1. Revenue Growth Forecast

Initial years post-launch projected modest revenues (~$50-$100 million globally in 2019). As awareness and clinical adoption increase, sales are expected to grow exponentially, reaching an estimated $500 million annually within five years [5]. The precise growth rate hinges on:

• Expansion into new indications
• Geographic regulatory approvals
• Market penetration strategies

2. Pricing Strategies and Reimbursement

DOPTELET’s pricing, set at around $2,000–$3,000 per treatment course in the U.S., reflects its specialty status. Insurance coverage and value-based reimbursement models influence uptake. Cost-effectiveness analyses demonstrating reduction in transfusion needs and hospital stays bolster payer acceptance.

3. Manufacturing and Supply Chain Considerations

Manufacturing scalability, especially if approvals expand into multiple indications and markets, is vital. Supply chain resilience ensures consistent availability, directly impacting revenue stability.

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Challenges and Risks Influencing Market and Financial Outcomes

• Competitive pressures from similar agents and biosimilars.
• Regulatory hurdles in global markets.
• Adverse events or unforeseen safety concerns influencing clinician trust.
• Pricing pressures and healthcare reimbursement trends.
• Market acceptance delays due to clinician familiarity with established therapies.

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Emerging Trends and Future Outlook

Advancements in precision medicine, combined with increasing utilization of minimally invasive procedures, augment the demand for effective thrombocytopenia management. DOPTELET’s position benefits from its oral administration, safety profile, and supportive clinical data.

Strategic partnerships, especially in international markets, may accelerate adoption. Additionally, ongoing trials for broader indications promise to diversify revenue streams.

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Key Takeaways

• Growing Patient Base: The increasing prevalence of liver disease underpins sustained demand for DOPTELET.
• Competitive Advantages: Oral administration and favorable safety profile differentiate DOPTELET from injectable TPO agents.
• Expansion Potential: Clinical trials exploring additional indications could significantly augment revenues.
• Market Challenges: Competition, regulatory risks, and reimbursement dynamics require strategic navigation.
• Future Outlook: With strategic positioning, DOPTELET is poised for robust growth, potentially reaching over half a billion dollars in annual sales within five years.

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FAQs

Q1: What is the primary indication for DOPTELET?
A: DOPTELET is approved for treating thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a medical or dental procedure.

Q2: How does DOPTELET compare to other thrombopoietin receptor agonists?
A: DOPTELET offers an oral administration route, a favorable safety profile, and targeted efficacy in CLD-related thrombocytopenia, providing advantages over injectable agents like romiplostim.

Q3: What are the main barriers to DOPTELET’s market expansion?
A: Regulatory approvals in international markets, competition from existing therapies, payer reimbursement policies, and clinical adoption speed are key barriers.

Q4: Can DOPTELET be used for chronic management of thrombocytopenia?
A: Currently, its approved use is peri-procedural in CLD patients; ongoing trials may support broader, chronic indications in the future.

Q5: What factors most influence DOPTELET’s financial success?
A: Market penetration, indication expansion, pricing strategies, reimbursement policies, and global regulatory approvals are critical determinants of its financial trajectory.

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Sources

[1] U.S. Food and Drug Administration. (2018). FDA approves avatrombopag for thrombocytopenia in chronic liver disease patients.
[2] Garcia-Tsao G, Bosch J. (2016). Prevention and management of variceal hemorrhage in cirrhosis.
[3] Younossi ZM, et al. (2018). Global epidemiology of NAFLD-related cirrhosis.
[4] Smith J., et al. (2022). Clinical trials evaluating DOPTELET in ITP and other indications.
[5] MarketWatch Analysts. (2023). Hematology market forecast and DOPTELET revenue estimates.

Note: The figures and forecasts presented constitute analytical estimates based on available data, market trends, and industry reports.