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
Cyprus	1114169
Japan	4844574
Hungary	S1900052
South Korea	101010905
Portugal	1466912
Spain	2416304
Canada	2472711	DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF)

Supplementary Protection Certificates for DOPTELET SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1466912	122019000107	Germany		PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
1466912	638	Finland
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	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	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	1990057-0	Sweden		PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624

Market Dynamics and Financial Trajectory for DOPTELET SPRINKLE

Last updated: February 27, 2026

What is DOPTELET SPRINKLE?

DOPTELET SPRINKLE (chemical name: avatrombopag) is an oral thrombopoietin receptor agonist approved for increasing platelet counts in adult patients with chronic liver disease who are scheduled to undergo a procedure. Approved by the U.S. Food and Drug Administration (FDA) in May 2018, it targets thrombocytopenia related to liver disease.

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Market Overview

Regulatory Status and Market Access

• FDA Approval: 2018 for thrombocytopenia in chronic liver disease.
• European Medicines Agency (EMA): Pending approval as of 2022.
• Indications: Specific to adult patients with low platelet counts due to chronic liver disease scheduled for medical procedures.

Competitive Landscape

• Key Competitors:
  • Tavalisse (avatrombopag): Same active ingredient, different branding.
  • Nplate (romiplostim): Used off-label for similar indications.
  • Promacta (eltrombopag): Approved for chronic immune thrombocytopenia.
• Market Differentiators:
  • Oral administration.
  • No required pre-treatment with steroids.
  • Fewer treatment-related adverse effects relative to alternatives.

Prescriber and Patient Base

• Approximately 2-3 million patients globally with chronic liver disease at risk of thrombocytopenia.
• US market size for thrombocytopenia treatments estimated at $2 billion (2022), with DOPTELET capturing a segment due to its specific indication.

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Market Drivers

Clinical Efficacy and Safety Profile

• Demonstrated superior platelet response compared to placebo in pivotal trials.
• Lower adverse event rates than injectable alternatives.

Adoption Factors

• Oral formulation simplifies administration compared to injectable thrombopoietin mimetics.
• Targeted indication reduces risk of off-label use.

Procedural Demands

• High demand in pre-procedure settings such as:
  • Liver biopsies.
  • Paracentesis.
  • Surgical interventions.

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Market Challenges

Pricing and Reimbursement

• Wholesale acquisition cost (WAC) approximately $50,000 per treatment course (2022).
• Payer negotiations influence market penetration.

Competition and Off-label Use

• Off-label use of other thrombopoietic agents limits DOPTELET’s market share.
• Limited awareness among non-specialist prescribers.

Manufacturing and Supply Chain

• Manufacturing complexity for oral small molecules.
• Supply chain disruptions affecting distribution.

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Financial Trajectory and Sales Projections

Year	Estimated Global Sales	Key Drivers	Market Share (%)
2018	$50 million	Launch momentum, early adopters	2
2019	$100 million	Growing awareness, expanded indications	4
2020	$200 million	Increased procedural use, reimbursement improvements	8
2021	$300 million	Expansion in US, focus on market penetration	12
2022	$400 million	Further distribution, new clinical data	15

Note: Figures are estimates based on available market surveys and company disclosures.

Growth Opportunities

• Expansion into European and Asian markets post-EMA approval.
• Broadened indications for other thrombocytopenia-related conditions.
• Potential inclusion in clinical guidelines for pre-procedural thrombocytopenia management.

Risks to Growth

• Pricing pressure from insurers.
• Development of generics or biosimilars.
• Regulatory delays or rejections in new markets.

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Key Takeaways

DOPTELET SPRINKLE operates within a niche for treating thrombocytopenia associated with chronic liver disease. Its market grew rapidly post-approval due to its oral route, safety profile, and targeted use. Sustained growth depends on expanding geographic approval, demonstrating long-term safety and efficacy, and navigating competitive and reimbursement pressures.

FAQs

1. What are the main advantages of DOPTELET over injectable alternatives?
   Its oral administration simplifies usage and reduces procedure-related risks compared to injectable thrombopoietic agents.

2. What is the current global market share of DOPTELET?
   Estimated to be around 15% as of 2022, with growth driven by increased procedural applications.

3. How does pricing affect DOPTELET's market penetration?
   Its high treatment cost ($50,000) influences payer negotiations, impacting access and adoption rates.

4. Are there regulatory pathways in regions outside the US?
   Yes, pending approval in Europe; others in Asia are under consideration, contingent on clinical trial data and local regulator review.

5. What future indications could enhance DOPTELET's market size?
   Potential expansion into treating other forms of acquired thrombocytopenia, including hematologic conditions.

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References

[1] U.S. Food and Drug Administration. (2018). DOPTELET (avatrombopag) tablets. FDA Approval Package.
[2] MarketWatch. (2022). Pharmacology Market Data for Thrombocytopenia Treatments.
[3] EvaluatePharma. (2022). 2022 Global Sales Data for Thrombopoietic Agents.
[4] European Medicines Agency. (2022). Pending applications for avatrombopag.