Avatrombopag maleate - Generic Drug Details

What are the generic sources for avatrombopag maleate and what is the scope of patent protection?

Avatrombopag maleate is the generic ingredient in one branded drug marketed by Akarx Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Avatrombopag maleate has twenty-one patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for avatrombopag maleate

International Patents:	21
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	4
Patent Applications:	8
What excipients (inactive ingredients) are in avatrombopag maleate?	avatrombopag maleate excipients list
DailyMed Link:	avatrombopag maleate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avatrombopag maleate

Constraining patent/regulatory exclusivity:

7,638,536

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 avatrombopag maleate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chinese PLA General Hospital	Phase 4
Eisai Inc.	Phase 3
Eisai Inc.	Phase 2

See all avatrombopag maleate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for avatrombopag maleate

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

US Patents and Regulatory Information for avatrombopag maleate

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 avatrombopag maleate

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 avatrombopag maleate

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 avatrombopag maleate

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

Avatrombopag maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Avatrombopag Maleate

Market Overview

Avatrombopag maleate, marketed under the brand name Doptelet, is an orally bioavailable, small-molecule thrombopoietin receptor agonist. This drug is used to treat severe thrombocytopenia in adult patients with chronic liver disease (CLD) and those with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments.

Market Size and Growth

The global market for oral thrombopoietin receptor agonists, which includes avatrombopag, is projected to grow significantly. As of 2023, the market size was estimated at $4.73 billion and is expected to reach $9.95 billion by 2034, growing at a compound annual growth rate (CAGR) of 7% from 2024 to 2034[1].

Regional Dominance

North America, particularly the U.S. and Canada, dominated the oral thrombopoietin receptor agonists market in 2023. This dominance is attributed to growing research, collaboration among key market players, government support, and investments in healthcare services. The Asia Pacific region is also witnessing significant growth due to increasing investments and collaborations among stakeholders, as well as a large population base[1].

Product Segment

Avatrombopag maleate is part of the lusutrombopag segment, which is expected to witness notable growth during the forecast period. Lusutrombopag is used to treat low platelets in adults with chronic liver disease, especially before invasive procedures, and is recognized for its safety and efficacy in increasing platelet counts and reducing the need for platelet transfusions[1].

Regulatory Milestones

Avatrombopag maleate has received significant regulatory approvals. In Canada, Health Canada issued a Notice of Compliance for Doptelet on November 3, 2023, authorizing its use for the treatment of severe thrombocytopenia in adult patients with CLD and ITP who have had an insufficient response to previous treatments[4].

In addition, Gyre Therapeutics received NMPA approval for avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia, further expanding its market presence[2].

Market Competitors and Emerging Therapies

The market for thrombopoietin receptor agonists is competitive, with other approved products such as eltrombopag providing competition to avatrombopag. However, avatrombopag's unique application in treating CLD-associated thrombocytopenia and its safety profile position it favorably in the market. Emerging therapies and late-stage clinical trials are also expected to influence the market dynamics, but avatrombopag's established presence and regulatory approvals give it a strong foothold[3].

Financial Performance

Gyre Therapeutics, a key player in the development and marketing of avatrombopag maleate, reported significant financial results. For the three months ended June 30, 2024, revenues were $25.2 million, although this was a decrease from the same period in 2023 due to normalized anti-fibrosis drug sales and foreign currency exchange rate impacts. The company's net income for the same period was $4.5 million, up from $3.8 million in the previous year[2].

Cost of Revenues and Expenses

The cost of revenues for Gyre Therapeutics decreased from $1.1 million in the second quarter of 2023 to $0.8 million in the second quarter of 2024, primarily due to factory renovation costs and decreased sales volume. Selling and marketing expenses also decreased, driven by lower conference costs, promotional expenses, and staff costs[2].

Research and Development

Gyre Therapeutics continues to invest in research and development, with a focus on expanding its product lines and addressing rare diseases. The company's R&D expenses increased due to costs associated with being a public company, including personnel costs and miscellaneous expenses[2].

Market Forecast

The market forecast for avatrombopag maleate is positive, driven by increasing healthcare spending and the need for effective treatments for thrombocytopenia. The comprehensive insights from market analyses, including SWOT analysis and detailed analyst views, suggest that the market size for Doptelet will expand as the drug penetrates more into the global market[3].

Key Findings

• Approval and Launch: Avatrombopag maleate has received approvals in several countries, including Canada, and is expected to launch in more markets, contributing to its growing market share[4].
• Clinical Trials: Ongoing and future clinical trials will further establish the safety and efficacy of avatrombopag, potentially expanding its indications and market reach[3].
• Market Competition: While other thrombopoietin receptor agonists like eltrombopag are competitors, avatrombopag's specific use cases and regulatory approvals position it competitively[1].

Conclusion

Avatrombopag maleate, under the brand name Doptelet, is poised for significant growth within the oral thrombopoietin receptor agonists market. With strong regulatory approvals, a favorable safety and efficacy profile, and ongoing research and development, this drug is expected to play a crucial role in treating thrombocytopenia associated with chronic liver disease and immune thrombocytopenia.

Key Takeaways

• Market Growth: The global market for oral thrombopoietin receptor agonists is projected to grow at a CAGR of 7% from 2024 to 2034.
• Regulatory Approvals: Avatrombopag maleate has received significant regulatory approvals, including from Health Canada and NMPA.
• Financial Performance: Gyre Therapeutics has reported positive financial results despite some decreases in revenues and costs.
• Market Competition: Avatrombopag maleate competes with other thrombopoietin receptor agonists but has a strong market position due to its specific use cases.
• Research and Development: Ongoing R&D activities are expected to further enhance the drug's market presence.

FAQs

1. What is avatrombopag maleate used for? Avatrombopag maleate is used to treat severe thrombocytopenia in adult patients with chronic liver disease and those with chronic immune thrombocytopenia who have had an insufficient response to previous treatments[4].

2. Which regions dominate the market for avatrombopag maleate? North America, particularly the U.S. and Canada, dominates the market, with the Asia Pacific region also showing significant growth[1].

3. What are the key regulatory milestones for avatrombopag maleate? Avatrombopag maleate has received approvals from Health Canada and NMPA, among others, for its use in treating CLD-associated thrombocytopenia[2][4].

4. How does avatrombopag maleate compare to other thrombopoietin receptor agonists? Avatrombopag maleate competes with other agonists like eltrombopag but has a strong market position due to its specific use cases and safety profile[1].

5. What is the financial outlook for Gyre Therapeutics regarding avatrombopag maleate? Gyre Therapeutics has reported positive financial results, with revenues and net income indicating a strong financial trajectory despite some fluctuations[2].