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 one NDA. 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 28, 2027. 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:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	7
Patent Applications:	110
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:

7,638,536

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 one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 7,638,536.

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	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018		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
European Patent Office	2314586	Dérivé 2-acylaminothiazole ou sel de celui-ci (2-Acylaminothiazole derivative or salt thereof)
Slovenia	1466912
World Intellectual Property Organization (WIPO)	03062233
Netherlands	301020
China	1319967
Japan	2008111001	2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF
South Korea	20040078122

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	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	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	2019C/547	Belgium		PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; 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	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	C20190040 00310	Estonia		PRODUCT NAME: AVATROMBOPAAG;REG NO/DATE: EU/1/19/1373 24.06.2019

Market Dynamics and Financial Trajectory of DOPTELET

Last updated: July 3, 2025

Introduction

DOPTELET, the brand name for avatrombopag, has emerged as a key player in the treatment of thrombocytopenia, a condition marked by low platelet counts that often accompanies chronic liver disease or immune thrombocytopenia (ITP). Approved by the U.S. Food and Drug Administration (FDA) in 2018, this oral thrombopoietin receptor agonist helps patients maintain adequate platelet levels before medical procedures, reducing bleeding risks. As the pharmaceutical sector grapples with rising demand for targeted therapies, understanding DOPTELET's market dynamics and financial trajectory offers critical insights for investors, executives, and healthcare strategists navigating an evolving landscape.

This analysis delves into the drug's competitive positioning, regulatory hurdles, sales performance, and future prospects, drawing on real-world data to equip business professionals with actionable intelligence. With the global thrombocytopenia market projected to expand amid aging populations and increasing liver disease prevalence, DOPTELET's story underscores the interplay between innovation, market forces, and financial sustainability.

Overview of DOPTELET

DOPTELET represents a significant advancement in hematology, specifically targeting patients with chronic liver disease who face thrombocytopenia prior to invasive procedures. Unlike traditional treatments such as platelet transfusions, which carry infection risks and limited efficacy, DOPTELET stimulates platelet production directly, offering a more convenient oral alternative. The drug's mechanism involves mimicking thrombopoietin, a natural hormone that regulates platelet formation, thereby addressing the root cause of the condition.

Developed by Dova Pharmaceuticals and later acquired by Swedish Orphan Biovitrum AB (Sobi) in 2020, DOPTELET has gained traction in major markets including the U.S. and Europe. Its approvals extend beyond the FDA, with the European Medicines Agency (EMA) granting authorization in 2019 for chronic liver disease-related thrombocytopenia. This expansion has broadened its reach, positioning it against competitors like GlaxoSmithKline's Promacta (eltrombopag), which dominates the ITP segment.

Market analysts highlight DOPTELET's appeal in a niche where unmet needs persist, particularly for patients ineligible for other therapies. However, its success hinges on navigating patent protections, which expire in the U.S. in 2033, potentially inviting generic competition. This overview sets the stage for examining how these factors shape broader market dynamics and financial outcomes.

Market Dynamics Shaping DOPTELET's Growth

The thrombocytopenia treatment market is evolving rapidly, driven by a surge in chronic liver diseases linked to obesity, alcohol consumption, and viral infections. Valued at approximately $1.5 billion globally in 2023, this sector is expected to grow at a compound annual growth rate (CAGR) of 7-9% through 2030, according to industry reports. DOPTELET capitalizes on this trend, commanding a growing share in the oral thrombopoietin agonist category, where it competes with established players and emerging biologics.

Regulatory environments play a pivotal role in DOPTELET's market positioning. In the U.S., the FDA's expedited approval process for orphan drugs like DOPTELET has facilitated faster market entry, granting it seven years of market exclusivity. This has shielded it from immediate competition, enabling Sobi to expand its footprint in key regions. Conversely, in Europe, pricing pressures from health authorities and reimbursement challenges have slowed adoption, with DOPTELET facing scrutiny over its cost-effectiveness compared to generics.

Competition intensifies DOPTELET's dynamics, with Novartis' Jakavi (ruxolitinib) and Amgen's Nplate (romiplostim) vying for market share in related indications. Yet, DOPTELET differentiates itself through its targeted efficacy in liver disease patients, where clinical trials demonstrated a 65-70% success rate in achieving safe platelet levels for procedures. Supply chain disruptions, exacerbated by the COVID-19 pandemic, have also influenced dynamics, temporarily boosting demand for home-administered treatments like DOPTELET.

Emerging markets in Asia-Pacific present untapped opportunities, where rising healthcare spending and increasing liver disease incidence could propel growth. For instance, partnerships with local distributors have helped Sobi penetrate China and India, though intellectual property enforcement remains a barrier. Overall, these dynamics underscore a market where innovation and strategic alliances will determine DOPTELET's long-term viability.

Financial Trajectory of DOPTELET

Since its launch, DOPTELET has demonstrated robust financial performance, reflecting Sobi's effective integration post-acquisition. In 2023, global sales of DOPTELET reached approximately $250 million, marking a 15% year-over-year increase driven by expanded indications and market penetration in the U.S. and Europe. This growth trajectory outpaces the broader pharmaceutical sector, where average revenue gains hover around 8-10%.

Sobi's financial reports reveal that DOPTELET contributed significantly to the company's overall revenue, accounting for about 20% of its pharmaceutical sales in 2023. Profit margins have improved steadily, rising from 45% in 2021 to 52% in 2023, thanks to cost efficiencies in manufacturing and marketing. However, challenges persist, including pricing pressures in regulated markets like Germany and France, where rebates and negotiations have eroded net revenues by 10-15%.

Investment in R&D has fueled DOPTELET's trajectory, with Sobi allocating $100 million in 2023 to explore new indications, such as chemotherapy-induced thrombocytopenia. This positions the drug for potential revenue uplifts, with analysts projecting an additional $50-100 million in annual sales if these expansions succeed. Mergers and acquisitions have also shaped finances; Sobi's 2020 acquisition of Dova for $710 million included DOPTELET's pipeline, delivering returns through scaled production and global distribution.

Looking at historical data, DOPTELET's revenue doubled from $120 million in 2020 to $250 million in 2023, buoyed by pandemic-related demand for non-hospital treatments. Future projections estimate revenues could hit $400 million by 2026, assuming no major patent challenges. Yet, financial risks loom, including currency fluctuations affecting international sales and potential biosimilar threats post-patent expiration. Sobi's stock has responded positively, with a 25% rise in share price over the past year, signaling investor confidence in DOPTELET's contributions.

Future Outlook and Challenges

As DOPTELET enters its next phase, its future hinges on ongoing clinical trials and market expansions. Sobi is pursuing approvals for pediatric use and additional liver disease subtypes, which could extend the drug's lifecycle beyond 2030. Technological advancements, such as digital health integrations for patient monitoring, may enhance adherence and open new revenue streams.

However, challenges abound, including a tightening regulatory landscape with increased scrutiny on drug pricing and efficacy data. Generic entrants could erode market share by 20-30% post-patent, prompting Sobi to explore defensive strategies like formulation improvements. Geopolitical factors, such as trade tensions impacting supply chains, add uncertainty, but strategic partnerships in emerging markets offer a counterbalance.

In summary, DOPTELET's outlook remains optimistic, with growth potential tied to innovation and global demand. Business leaders must monitor these trends to capitalize on opportunities while mitigating risks.

Key Takeaways

• DOPTELET has solidified its position in the thrombocytopenia market, with 2023 sales reaching $250 million and a projected CAGR of 10-15% through 2026.
• Regulatory exclusivities and targeted efficacy provide a competitive edge, though pricing pressures and potential generics pose threats.
• Sobi's acquisition and R&D investments have driven financial gains, enhancing profitability and market expansion.
• Emerging markets and new indications could boost revenues, but intellectual property risks require proactive management.
• Investors should weigh DOPTELET's growth trajectory against broader industry dynamics for informed decision-making.

FAQs

1. What factors are driving DOPTELET's market growth?
DOPTELET's expansion stems from increasing chronic liver disease cases and its efficacy as an oral alternative to transfusions, with market growth projected at 7-9% CAGR globally.

2. How has Sobi's acquisition impacted DOPTELET's finances?
The 2020 acquisition enabled Sobi to scale production and distribution, boosting DOPTELET's revenues from $120 million in 2020 to $250 million in 2023 through enhanced market access.

3. What competition does DOPTELET face?
DOPTELET competes with drugs like Promacta and Nplate, but its specific focus on liver disease-related thrombocytopenia differentiates it in a crowded market.

4. When might generic versions of DOPTELET appear?
U.S. patents expire in 2033, potentially allowing generics to enter, which could reduce DOPTELET's market share by 20-30% unless Sobi innovates further.

5. How does DOPTELET fit into broader pharmaceutical trends?
As an orphan drug, DOPTELET aligns with the trend toward targeted therapies, offering insights into how niche markets can deliver strong financial returns amid regulatory support.

Sources

1. U.S. Food and Drug Administration. FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease. Accessed via FDA website, 2018 approval documents.

2. Sobi Annual Report 2023. Financial performance and sales data for DOPTELET, including revenue figures and R&D investments.

3. Grand View Research. Thrombocytopenia Drugs Market Size, Share & Trends Analysis Report, 2023-2030, for market size and growth projections.