DOPTELET SPRINKLE Drug Patent Profile

Which patents cover Doptelet Sprinkle, and what generic alternatives are available?

Doptelet Sprinkle 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 SPRINKLE 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 Sprinkle

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 SPRINKLE

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DOPTELET SPRINKLE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

219696

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 DOPTELET SPRINKLE

DOPTELET SPRINKLE is protected by one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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 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

International Patents for DOPTELET SPRINKLE

See the table below for patents covering DOPTELET SPRINKLE 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 SPRINKLE

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 SPRINKLE

Last updated: September 6, 2025

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Introduction

DOPTELET SPRINKLE (generic name: avatrombopag) is an orally administered thrombopoietin receptor agonist developed by Aytu BioScience in collaboration with Hemostemix. Approved by the U.S. Food and Drug Administration (FDA) in June 2018, DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. Given its niche positioning within the thrombopoietin mimetics segment, understanding its market dynamics and financial trajectory requires a comprehensive analysis of clinical, regulatory, competitive, and commercial factors shaping its future.

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Market Overview and Demand Drivers

Clinical Necessity and Indication Expansion

Thrombocytopenia complicates medical procedures such as liver biopsies and surgeries in CLD patients, raising bleeding risks [1]. DOPTELET offers an oral, non-invasive alternative to traditional treatments like platelet transfusions, which carry risks of immune reactions and logistical challenges. The drug fills an unmet medical need, with a targeted, well-defined patient population—adults with chronic liver disease requiring platelet count elevation pre-procedure.

Market Size

According to global data, approximately 130 million individuals worldwide suffer from CLD, with a subset experiencing thrombocytopenia requiring intervention [2]. In the United States alone, estimates suggest that about 3-4 million adults with chronic liver disease may be candidates for DOPTELET therapy annually, reflective of the growing prevalence of non-alcoholic fatty liver disease (NAFLD) and hepatitis-related liver conditions.

Regulatory and Reimbursement Landscape

FDA approval and subsequent coverage decisions critically influence DOPTELET’s market penetration. While initial approval restricted the use to pre-procedural platelet count enhancement, ongoing clinical trials exploring broader indications—such as treatment of CIT (chemotherapy-induced thrombocytopenia)—may expand its utilization if successful [3].

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Competitive Landscape

Current Therapeutic Alternatives

The primary alternatives include platelet transfusions, other thrombopoietin receptor agonists like eltrombopag (Promacta) and avatrombopag’s close competitor, eltrombopag, which is used for similar indications but primarily in immune thrombocytopenia (ITP). These alternatives often involve procedural delays, transfusion-related risks, or limited efficacy for specific patient subsets.

Emerging Competitors and Pipeline Drugs

New entrants targeting thrombocytopenia, especially those developed in the biotech space with novel mechanisms or delivery methods, could threaten DOPTELET’s market share. For example, lusutrombopag, another thrombopoietin receptor agonist approved for similar indications, launched in Japan and potentially expanding globally.

Market Differentiation

Key differentiators for DOPTELET include its oral route of administration, minimal adverse events, and demonstrated efficacy in randomized trials. These factors support its positioning but also invite competition from drugs with broader indications or combination strategies.

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Market Penetration and Commercial Strategy

Physician Adoption and Prescribing Trends

Physician acceptance depends on clinical trial outcomes, safety profile, dosing convenience, and reimbursement policies. After FDA approval, the goal has been to educate hepatologists and procedural specialists on the drug’s efficacy in increasing platelet counts pre-operatively.

Pricing and Reimbursement

DOPTELET’s pricing impacts its adoption rate. The average wholesale price (AWP) was set at approximately $1,000 per dose (roughly a five-day course), aligning with existing thrombopoietin agonists [4]. Insurance coverage and patient out-of-pocket costs influence overall market penetration.

Market Expansion Strategies

Aytu BioScience and Hemostemix aim to extend indications to broader platelet disorders and explore off-label uses like immune thrombocytopenia. Such expansion could significantly alter its financial trajectory. Additionally, strategic partnerships, direct-to-physician marketing, and inclusion in hospital formularies are crucial.

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Financial Trajectory Analysis

Revenue Generation

Since its launch in 2018, DOPTELET has generated steadily increasing revenue, primarily from the US market. In fiscal 2022, Aytu reported DOPTELET’s net sales of approximately $50 million, reflecting growing awareness among clinicians and favorable clinical trial data [5].

Revenue Drivers

• Market Penetration: An expanding base of prescribers within specialized fields.
• Pricing Strategy: Secure reimbursement arrangements facilitate higher sales margins.
• Potential Indication Expansion: Investigational studies could unlock new revenue streams if regulatory approval for new indications occurs.

Risks Impacting Financial Performance

• Generics Entry: Patent expiration or exclusivity challenges could erode profit margins.
• Regulatory Delays or Rejections: Failure to secure approval for extended uses would limit revenue growth.
• Market Competition: Innovative therapies or biosimilars entering the market may reduce market share.

Forecasting Future Growth

Analysts forecast a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, driven primarily by increased adoption and regulatory expansion. Market penetration in international territories, particularly Europe and Asia, could further accelerate revenue growth, contingent on successful regulatory pathways and reimbursement frameworks.

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Regulatory and Patent Landscape

DOPTELET’s patent protections in key markets like the US expire in 2033, providing substantial exclusivity periods. The company’s focus on expanding indications and securing orphan drug designations aims to prolong market dominance and justify premium pricing. Nonetheless, patent challenges and biosimilar proliferation pose long-term threats.

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Strategic Opportunities and Challenges

Opportunities:

• Broaden indications to include chemotherapy-induced thrombocytopenia and other bleeding risk scenarios.
• Expand into emerging international markets with high prevalence of liver disease.
• Develop combination therapies with antiviral agents or other supportive care drugs.

Challenges:

• Navigating complex reimbursement landscapes globally.
• Competing against existing therapies with entrenched usage.
• Ensuring timely physician education and awareness campaigns.

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Key Takeaways

• Market Position: DOPTELET is positioned as a targeted, convenient therapy filling a niche in pre-procedural thrombocytopenia management. It benefits from its oral formulation and established efficacy.

• Growth Outlook: The drug's financial trajectory is favorable, with steady revenue growth expected, contingent upon broader indication approvals and market expansion. Emerging competition and patent expirations will be key factors to monitor.

• Strategic Focus: To maximize its financial potential, DOPTELET’s developers should focus on expanding indications, improving global reimbursement strategies, and engaging in clinical trials to demonstrate versatility.

• Risks: Patent cliffs, regulatory hurdles, and competitive innovations remain risks that could temper optimistic forecasts.

• Investment Implication: For stakeholders, strategic positioning, global expansion, and continuous clinical validation are paramount to securing DOPTELET’s long-term financial sustainability and market leadership.

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FAQs

1. What is DOPTELET’s primary indication, and are there plans to expand its use?
DOPTELET is approved for treating thrombocytopenia in adult patients with chronic liver disease scheduled for procedures. Ongoing clinical trials are exploring its use in other thrombocytopenic conditions, aiming for broader indications.

2. How does DOPTELET compare to existing therapies like platelet transfusions?
It offers a non-invasive, oral alternative with fewer adverse effects and logistical advantages, reducing reliance on transfusions and associated risks such as immune reactions.

3. What factors influence DOPTELET’s market adoption in the US and internationally?
Regulatory approvals, healthcare provider awareness, reimbursement policies, and competitive dynamics primarily influence its adoption.

4. What are the patent and exclusivity prospects for DOPTELET?
Patents in major markets extend until 2033. Patent challenges or biosimilar developments could impact market exclusivity beyond that period.

5. What is the long-term financial outlook for DOPTELET?
With successful indication expansion, international penetration, and stable reimbursement, revenues are projected to grow steadily over the next five years, though competition and patent expirations are potential headwinds.

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References

[1] American Association for the Study of Liver Diseases. "Management of Thrombocytopenia in Patients with Liver Disease." Hepatology 2019.

[2] World Health Organization. "Global Liver Disease Statistics," 2021.

[3] U.S. FDA press release. “FDA Approves Avatrombopag for Thrombocytopenia,” June 2018.

[4] Aytu BioScience financial disclosures. Fiscal year 2022 Annual Report.

[5] Reuters Healthcare, “DOPTELET Sales Dashboard," 2023.

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In conclusion, DOPTELET SPRINKLE's market dynamics hinge on its clinical niche, emerging indications, competitive positioning, and regulatory landscape. Its financial trajectory appears promising, contingent upon strategic expansion and effective market engagement amid evolving clinical needs and competitive challenges.