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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:	67
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
Japan	2008111001	2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF
Hungary	S1900052
China	1639157
Luxembourg	C00137
Spain	2610611
Slovenia	1466912
Japan	WO2003062233	２−アシルアミノチアゾール誘導体又はその塩

Supplementary Protection Certificates for DOPTELET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	638	Finland
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
1466912	122019000107	Germany		PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
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

DOPTELET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doptelet (Avatrombopag)

Introduction to Doptelet (Avatrombopag)

Doptelet, also known as avatrombopag, is a second-generation, once-daily, orally administered thrombopoietin (TPO) receptor agonist. It is approved for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. This drug mimics the effects of TPO, the primary regulator of normal platelet production[1][4].

Mechanism of Action and Clinical Use

Doptelet works by stimulating the TPO receptor, which leads to an increase in platelet production. This mechanism is crucial for patients with CLD who often have low platelet counts, making them susceptible to bleeding complications during surgical procedures. The drug's oral administration and once-daily dosing make it a convenient option for patients[1][4].

Market Assessment

The market for Doptelet is analyzed across seven major markets: the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Here are some key points regarding the market dynamics:

Historical and Forecasted Sales

The sales data for Doptelet from 2017 to 2030 indicate a growing market trend. The report provides historical and forecasted sales data, which will help clients in decision-making regarding their therapeutic portfolios. The market is expected to expand due to extensive research in the treatment of thrombocytopenia and increased healthcare spending globally[1][4].

Market Competitors

Doptelet faces competition from other approved products for thrombocytopenia, such as NPLATE/ROMIPLATE (romiplostim) and PROMACTA/REVOLADE. The launch of late-stage emerging therapies is expected to significantly impact the market, making it crucial for Doptelet to maintain its market share through innovative strategies and clinical advancements[1][3][4].

SWOT Analysis

The SWOT analysis for Doptelet highlights its strengths, such as its convenient dosing regimen and efficacy in treating thrombocytopenia. However, it also notes weaknesses, including potential side effects like portal vein thrombosis in patients with CLD. Opportunities include the growing demand for effective thrombocytopenia treatments and the potential for label expansion. Threats include competition from emerging therapies and regulatory challenges[1][4].

Regulatory Milestones and Development Activities

Doptelet has achieved several regulatory milestones, including its approval in the United States, EU, and Japan. The report details these milestones and other development activities, which are crucial for understanding the drug's market position and future potential. Regulatory approvals and patent details are also highlighted, providing a comprehensive view of the drug's legal and developmental landscape[1][4].

Financial Trajectory

Revenue Projections

The financial trajectory for Doptelet is positive, with projected growth driven by increasing demand for effective treatments for thrombocytopenia. The report forecasts significant revenue growth from 2017 to 2030, supported by detailed sales data and market assessments[1][4].

Investment and Competitor Landscape

Companies and academics are actively working to assess challenges and seek opportunities that could influence Doptelet's market dominance. The focus on novel approaches to treat thrombocytopenia and the emergence of new therapies will continue to shape the financial trajectory of Doptelet. Investors and stakeholders need to consider these factors when evaluating the drug's potential for long-term growth[1][3][4].

Geographic Market Share

• United States: The US market accounts for a significant share of Doptelet's sales, driven by high healthcare spending and a large patient population.
• EU5 and UK: These regions also contribute substantially to the drug's revenue, with the UK having a notable market share within the EU4 and UK segment.
• Japan: The Japanese market, though smaller, is still an important segment, with a market size estimated to be around USD 300 million in 2023[1][3][4].

Emerging Therapies and Market Impact

The ITP and thrombocytopenia markets are poised for substantial growth with the introduction of novel therapies, including biologics, small molecules, and targeted treatments. Emerging therapies such as Rilzabrutinib (Sanofi), Ianalumab (Novartis), and Mezagitamab (Takeda) will likely impact Doptelet's market share. The ability of Doptelet to compete effectively will depend on its clinical efficacy, safety profile, and strategic marketing efforts[3].

Challenges and Opportunities

Challenges

• Competition: The market is highly competitive, with other approved products and emerging therapies vying for market share.
• Regulatory: Maintaining regulatory approvals and navigating potential changes in regulatory environments is crucial.
• Safety Concerns: Side effects such as portal vein thrombosis need to be managed and communicated effectively to healthcare providers and patients.

Opportunities

• Growing Demand: Increasing awareness and diagnosis of thrombocytopenia offer a growing market opportunity.
• Label Expansion: Potential for expanding the drug's indications to other patient populations.
• Global Expansion: Further penetration into international markets, especially in regions with growing healthcare spending[1][3][4].

Key Takeaways

• Doptelet is a second-generation TPO receptor agonist with a strong market presence in treating thrombocytopenia.
• The drug faces competition from other approved products and emerging therapies.
• Market growth is driven by increasing healthcare spending and the need for effective thrombocytopenia treatments.
• Regulatory milestones and patent details are critical for the drug's continued success.
• Geographic market share is significant in the US, EU5, UK, and Japan.

FAQs

What is Doptelet (Avatrombopag) used for?

Doptelet (avatrombopag) is used for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

How does Doptelet work?

Doptelet works by stimulating the TPO receptor, which leads to an increase in platelet production, mimicking the effects of thrombopoietin (TPO).

What are the potential side effects of Doptelet?

Potential side effects include portal vein thrombosis in patients with CLD, among other adverse reactions.

Who are the main competitors of Doptelet in the market?

The main competitors include other approved products such as NPLATE/ROMIPLATE (romiplostim) and PROMACTA/REVOLADE, as well as emerging therapies like Rilzabrutinib and Ianalumab.

What is the projected market growth for Doptelet until 2030?

The market for Doptelet is expected to grow significantly until 2030, driven by increasing demand for effective thrombocytopenia treatments and incremental healthcare spending globally.

Cited Sources:

1. GlobeNewswire: "Doptelet (Avatrombopag) - Drug Insight and Market Forecast - 2030" report.
2. Asahi Kasei Corporation: Management Briefing 2024.
3. GlobeNewswire: "Immune Thrombocytopenia (ITP) Industry Analysis and Forecast 2020-2034".
4. BusinessWire: "Global Doptelet (Avatrombopag) Industry to 2030 - Drug Insight and Market Forecast".