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Last Updated: December 22, 2024

DASATINIB Drug Patent Profile


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Which patents cover Dasatinib, and when can generic versions of Dasatinib launch?

Dasatinib is a drug marketed by Apotex and is included in two NDAs.

The generic ingredient in DASATINIB is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dasatinib

A generic version of DASATINIB was approved as dasatinib by APOTEX on June 10th, 2016.

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Drug patent expirations by year for DASATINIB
Recent Clinical Trials for DASATINIB

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

SponsorPhase
Hospital Universitario Dr. Jose E. GonzalezPhase 2
Fernando De la Garza SalazarPhase 2
Institut Paoli-CalmettesPhase 2

See all DASATINIB clinical trials

Pharmacology for DASATINIB
Medical Subject Heading (MeSH) Categories for DASATINIB
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

DASATINIB is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex DASATINIB dasatinib TABLET;ORAL 202103-001 Jun 10, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex DASATINIB dasatinib TABLET;ORAL 203180-001 Nov 23, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex DASATINIB dasatinib TABLET;ORAL 202103-002 Jun 10, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex DASATINIB dasatinib TABLET;ORAL 202103-003 Jun 10, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex DASATINIB dasatinib TABLET;ORAL 203180-002 Nov 23, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DASATINIB Market Analysis and Financial Projection Experimental

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

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