Dasatinib - Generic Drug Details

What are the generic drug sources for dasatinib and what is the scope of freedom to operate?

Dasatinib is the generic ingredient in three branded drugs marketed by Apotex, Handa Therap, and Bristol Myers Squibb, and is included in four NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dasatinib has fifty-three patent family members in twenty-nine countries.

There are fourteen drug master file entries for dasatinib. Four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for dasatinib

International Patents:	53
US Patents:	5
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	361
Patent Applications:	6,922
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dasatinib
What excipients (inactive ingredients) are in dasatinib?	dasatinib excipients list
DailyMed Link:	dasatinib at DailyMed

Recent Clinical Trials for dasatinib

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

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Institut Paoli-Calmettes	Phase 2

See all dasatinib clinical trials

Generic filers with tentative approvals for DASATINIB

Applicant	Application No.	Strength	Dosage Form
		70MG	TABLET;ORAL
		50MG	TABLET;ORAL
		140MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dasatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for dasatinib

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dasatinib

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for DASATINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRYCEL	Tablets	dasatinib	80 mg and 140 mg	021986	1	2011-06-17
SPRYCEL	Tablets	dasatinib	20 mg, 50 mg, 70 mg and 100 mg	021986	1	2010-06-28

US Patents and Regulatory Information for dasatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	AB	RX	Yes	No	7,491,725*PED				Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	AB	RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,202,778
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	AB	RX	Yes	No	7,491,725*PED				Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No	11,202,778

Expired US Patents for dasatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	7,153,856*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	7,125,875*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	7,153,856*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	7,125,875*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	6,596,746*PED

International Patents for dasatinib

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1812432	COMBINAISON D'UN INHIBITEUR DE LA SRC KINASE ET DE BCR-ABL DESTINEE AU TRAITEMENT DE MALADIES A EVOLUTION CHRONIQUE (COMBINATION OF A SRC KINASE INHIBITOR AND A BCR-ABL INHIBITOR FOR THE TREATMENT OF PROLIFERATIVE DISEASES)
South Korea	101310427
Russian Federation	2007120710	СПОСОБ ЛЕЧЕНИЯ РАКА И/ИЛИ ЛЕЙКОЗА И ПРИМЕНЯЕМАЯ В НЕМ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Taiwan	200530205	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
Taiwan	I338004
South Korea	20070073864	COMBINATION OF A SRC KINASE INHIBITOR AND A BCR-ABL INHIBITOR FOR THE TREATMENT OF PROLIFERATIVE DISEASES
Germany	602005018601

Supplementary Protection Certificates for dasatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	2013C/005	Belgium		PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038	300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	1390004-8	Sweden		PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038	122013000012	Germany		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120
1169038	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038	C300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120

Market Dynamics and Financial Trajectory for Dasatinib

Introduction

Dasatinib, marketed under the brand name Sprycel, is a second-generation tyrosine kinase inhibitor that has revolutionized the treatment of certain types of cancer, particularly chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we delve into the market dynamics and financial trajectory of dasatinib, highlighting key trends, drivers, and challenges.

Market Size and Growth

The global dasatinib drugs market has experienced robust growth in recent years. As of 2023, the market size was valued at $1.36 billion and is expected to grow to $1.45 billion in 2024, with a compound annual growth rate (CAGR) of 6.6%[1][4].

By 2028, the market is projected to reach $1.87 billion, maintaining a CAGR of 6.7% during the forecast period. This growth is driven by several factors, including the increasing prevalence of CML, advancements in tyrosine kinase inhibitors (TKIs) research, and larger investments in oncology drug pipelines[1][4][5].

Key Drivers of Growth

Increasing Prevalence of Leukemia

The rising number of cases of CML and other leukemias is a significant driver of the dasatinib market. As the incidence of these diseases increases, so does the demand for effective treatments like dasatinib[1][3][4].

Advancements in Targeted Cancer Therapies

The growth in targeted cancer therapies, particularly TKIs, has been instrumental in driving the market. Dasatinib's efficacy in targeting the BCR-ABL protein and other tyrosine kinases has made it a preferred treatment option[1][3][4].

Investment in Oncology Research

Increased investment in oncology research and the rise in the number of clinical trials have contributed to the market's growth. These investments are leading to new formulations, combination therapies, and the development of biosimilars[1][3][4].

Growing Availability of Generic Versions

The impending launch of generic dasatinib drugs is expected to further boost the market. The first generic version, Dasynoc by XSpray Pharma, is set to hit the market in September 2024, which will increase accessibility and affordability of the drug[2][4].

Market Trends

Adoption of Personalized Medicine

The adoption of personalized medicine is a key trend in the dasatinib market. Tailoring treatments to individual patient profiles is expected to enhance efficacy and reduce side effects[1][4].

Implementation of Companion Diagnostics

Companion diagnostics are being increasingly used to identify patients who would benefit most from dasatinib treatment. This approach helps in optimizing treatment outcomes and reducing unnecessary side effects[1][4].

Development of New Formulations and Combination Therapies

Ongoing research is focused on developing new formulations and combination therapies involving dasatinib. These advancements are expected to broaden the drug's application and improve patient outcomes[1][3][4].

Development of Biosimilars

The development of biosimilars is another significant trend. Biosimilars offer a cost-effective alternative to branded drugs, which can increase market penetration and accessibility[1][4].

Regional Analysis

North America

North America was the largest region in the dasatinib drugs market in 2023, driven by high healthcare spending and advanced medical infrastructure[1].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market during the forecast period, driven by increasing healthcare expenditure, growing awareness of cancer treatments, and expanding patient populations[1].

Competitive Landscape

Bristol-Myers Squibb (BMS)

BMS is the dominant player in the dasatinib market with its brand Sprycel. However, the company is facing challenges from generic competitors. BMS has been expanding its oncology pipeline with new candidates and seeking approvals for additional indications for Sprycel[1][2].

Generic Competitors

Companies like XSpray Pharma, Biocon, and Teva are developing generic versions of dasatinib. The entry of these generics is expected to increase competition and potentially reduce prices in the market[2].

Financial Performance

Sprycel has been a blockbuster drug for BMS, with sales reaching $1.9 billion in 2023. However, the impending launch of generics poses a significant threat to BMS's revenue from Sprycel. The company is diversifying its portfolio with other cancer treatments, such as Breyanzi, a CAR-T cell therapy, to mitigate this impact[2].

Challenges

Patent Expirations

The expiration of patents for dasatinib, particularly the monohydrate form patents set to expire in 2025 and 2026, will allow generic competitors to enter the market. This could significantly impact BMS's sales and market share[2].

High Cost of Treatment

The high cost of dasatinib treatment is a barrier to access for many patients. This could limit market growth, especially in regions with lower healthcare spending[3].

Potential Adverse Effects

Dasatinib, like other TKIs, can have significant side effects, which necessitate careful monitoring and management. This could affect patient compliance and overall market growth[3].

Conclusion

The dasatinib drugs market is poised for strong growth driven by increasing prevalence of leukemia, advancements in targeted therapies, and growing investment in oncology research. However, the market also faces challenges such as patent expirations, high treatment costs, and potential adverse effects. As the market evolves, the adoption of personalized medicine, implementation of companion diagnostics, and development of new formulations and biosimilars will play crucial roles in shaping its future.

Key Takeaways

• The global dasatinib drugs market is expected to grow to $1.87 billion by 2028 at a CAGR of 6.7%.
• Increasing prevalence of CML, advancements in TKIs, and larger investments in oncology research are key drivers.
• Generic versions of dasatinib are set to enter the market, increasing accessibility and competition.
• Personalized medicine, companion diagnostics, and new formulations are significant trends.
• North America is the largest market, while Asia-Pacific is expected to be the fastest-growing region.

FAQs

What is dasatinib used for?

Dasatinib is used to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) by inhibiting the BCR-ABL protein.

What is the current market size of dasatinib drugs?

The current market size of dasatinib drugs is valued at $1.36 billion in 2023.

What is the expected growth rate of the dasatinib drugs market?

The dasatinib drugs market is expected to grow at a CAGR of 6.7% from 2023 to 2028.

Which region is expected to be the fastest-growing market for dasatinib?

The Asia-Pacific region is expected to be the fastest-growing market for dasatinib during the forecast period.

What are the major trends in the dasatinib drugs market?

Major trends include the adoption of personalized medicine, implementation of companion diagnostics, development of new formulations, advancements in combination therapies, and the creation of biosimilars.

Sources

1. The Business Research Company: Dasatinib Drugs Global Market Report 2024
2. PharmaVoice: BMS' long-standing leukemia blockbuster stares down its first generic
3. Coherent Market Insights: Dasatinib Drugs Market, By Type, By Indication, By Distribution
4. EINPresswire: Global Dasatinib Drugs Market Set For 6.7% Growth, Reaching $1.87 Billion By 2028
5. Coherent Market Insights: Sprycel Market Size & Share Analysis - Industry Research Report