SPRYCEL Drug Patent Profile

When do Sprycel patents expire, and what generic alternatives are available?

Sprycel is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in SPRYCEL 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 Sprycel

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

Summary for SPRYCEL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	178
Patent Applications:	4,292
Drug Prices:	Drug price information for SPRYCEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRYCEL
What excipients (inactive ingredients) are in SPRYCEL?	SPRYCEL excipients list
DailyMed Link:	SPRYCEL at DailyMed

See drug prices for SPRYCEL

Recent Clinical Trials for SPRYCEL

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
Odense Patient Data Explorative Network	Phase 2

See all SPRYCEL clinical trials

Pharmacology for SPRYCEL

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

Paragraph IV (Patent) Challenges for SPRYCEL

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 SPRYCEL

SPRYCEL is protected by two US patents and four FDA Regulatory Exclusivities.

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	021986-006	Oct 28, 2010	AB	RX	Yes	No	8,680,103*PED				Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	AB	RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No

Expired US Patents for SPRYCEL

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	021986-003	Jun 28, 2006	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	7,153,856*PED

International Patents for SPRYCEL

See the table below for patents covering SPRYCEL around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0009721	inibidores de tirosina quinase de proteína cíclica
Austria	464898
Germany	602004026703

Supplementary Protection Certificates for SPRYCEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01169038/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120

SPRYCEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SPRYCEL

Introduction

SPRYCEL, also known as dasatinib, is a second-generation tyrosine kinase inhibitor used primarily to treat certain forms of leukemia, including chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we delve into the market dynamics and financial trajectory of SPRYCEL, highlighting key trends, drivers, and challenges.

Market Size and Growth

The global SPRYCEL market is valued at different estimates depending on the source. As of 2022, the market size was estimated to be around USD 5.47 billion and is projected to reach USD 8.52 billion by 2031, growing at a CAGR of 5.2% during the forecast period[1].

Another estimate suggests that the global SPRYCEL market was valued at USD 2.22 billion in 2023 and is expected to grow to USD 2.69 billion by 2030, with a CAGR of 2.8% during the forecast period[4].

Market Segmentation

The SPRYCEL market is segmented based on several criteria:

• Demographic Segmentation: This includes age, gender, and income. The high income of the population in developing countries is a significant factor driving the use of branded drugs like SPRYCEL[1].
• Psychographic Segmentation: Lifestyle and attitudes play a crucial role, with the lifestyle segment being a major contributor due to changes in population lifestyles in developing countries[1].
• Behavioral Segmentation: This includes usage rate, compliance, and treatment. The compliance and treatment segments are critical as they directly impact the drug's efficacy and market growth[1].
• Medical Segmentation: This is based on indication and disease stage. The disease stage segment, particularly for Ph+ CML in the chronic phase, is expected to grow rapidly due to the increasing use of SPRYCEL in these treatments[1].

Regional Insights

The North American region holds a significant revenue share in the SPRYCEL market. This is attributed to increased research on hereditary and rare disorders, the presence of key players, and government funding in the region[1].

Key Players

The SPRYCEL market is dominated by several major pharmaceutical companies, including:

• Bristol-Myers Squibb (BMS): The primary manufacturer and marketer of SPRYCEL.
• Novartis
• Teva Pharmaceutical Industries
• Mylan
• Accord Healthcare
• Sun Pharma
• Dr. Reddy's Laboratories
• Aurobindo Pharma[1].

Market Drivers

Several factors drive the growth of the SPRYCEL market:

• Increasing Prevalence of CML and Ph+ ALL: According to the World Health Organization, CML is the most common type of leukemia, with an estimated 200,000 new cases diagnosed each year. Ph+ ALL, though rare, is more aggressive and often fatal[4].
• Advancements in Targeted Therapy: SPRYCEL's effectiveness as a targeted therapy for specific types of leukemia contributes to its market growth.
• Government Funding and Research: Increased funding for research on rare and hereditary disorders boosts the market for drugs like SPRYCEL[1].

Market Restraints

Despite the growth drivers, the SPRYCEL market faces several challenges:

• High Cost and Reimbursement Issues: The high cost of SPRYCEL can be a barrier for many patients, especially in regions with limited healthcare reimbursement policies[4].
• Generic Competition: The potential entry of generic versions of dasatinib could reduce the market share of branded SPRYCEL.
• Adverse Events and Safety Concerns: Like many cancer drugs, SPRYCEL can have adverse effects, which may impact patient compliance and market growth.
• Development of Resistance: The development of resistance to dasatinib is a significant concern, as it can reduce the drug's efficacy over time[4].

Financial Performance of Bristol-Myers Squibb

Bristol-Myers Squibb, the primary manufacturer of SPRYCEL, has reported mixed financial results in recent years:

• Revenue Decline for SPRYCEL: In the fourth quarter of 2023, SPRYCEL revenues declined by 32% compared to the same period in 2022, reflecting a global decline of 31%[2].
• Overall Company Performance: Despite the decline in SPRYCEL revenues, Bristol-Myers Squibb reported strong performance in other in-line and new products, with total revenues of $11.477 billion for the fourth quarter of 2023[2].
• Pipeline and Business Development: The company has been focusing on strengthening its pipeline and portfolio through various business development activities, which is expected to support long-term growth[2].

Recent Developments

Bristol-Myers Squibb has been active in enhancing its portfolio and pipeline:

• Transactions and Acquisitions: The company entered into multiple transactions in December 2023 to strengthen its long-term growth profile and enhance its portfolio and pipeline[2].
• Focus on Commercial Execution: For 2024, the company is focused on delivering strong commercial execution and accelerating opportunities that enhance its growth profile in the mid-decade and beyond[2].

Regional Market Share

The North American region is expected to continue holding a significant market share due to the factors mentioned earlier. Here is a snapshot of the regional market share:

• North America: Expected to record the highest market revenue share due to increased research, presence of key players, and government funding[1].
• Europe, Asia Pacific, Latin America, Middle East & Africa: These regions also contribute to the global market, though to a lesser extent compared to North America[1].

Patient Demographics

The market is also influenced by patient demographics:

• Age and Gender: The prevalence of CML and Ph+ ALL varies across different age groups and genders, which affects the market segmentation and targeting strategies[4].
• Income and Lifestyle: High-income populations and changes in lifestyle, especially in developing countries, are significant factors driving the market for branded drugs like SPRYCEL[1].

Key Takeaways

• The SPRYCEL market is projected to grow significantly, driven by the increasing prevalence of CML and Ph+ ALL.
• The North American region holds a significant market share due to research, key players, and government funding.
• High cost, generic competition, and adverse events are major restraints.
• Bristol-Myers Squibb's financial performance is mixed, with a decline in SPRYCEL revenues but overall strong company performance.
• The company is focusing on pipeline acceleration and business development to support long-term growth.

FAQs

What is SPRYCEL used for?

SPRYCEL (dasatinib) is used to treat certain forms of leukemia, including chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)[4].

Who are the key players in the SPRYCEL market?

Key players include Bristol-Myers Squibb (BMS), Novartis, Teva Pharmaceutical Industries, Mylan, Accord Healthcare, Sun Pharma, Dr. Reddy's Laboratories, and Aurobindo Pharma[1].

What are the major drivers of the SPRYCEL market?

The market is driven by the increasing prevalence of CML and Ph+ ALL, advancements in targeted therapy, and government funding for research on rare disorders[1][4].

What are the significant restraints for the SPRYCEL market?

High cost, reimbursement issues, generic competition, adverse events, and the development of resistance are major restraints[4].

How is Bristol-Myers Squibb performing financially with regards to SPRYCEL?

Bristol-Myers Squibb reported a decline in SPRYCEL revenues but overall strong performance in other products and a focus on pipeline acceleration and business development[2].

Sources

1. InsightAce Analytic: Sprycel Market Share, Size, Growth and Forecast to 2031[1].
2. Bristol Myers Squibb: Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023[2].
3. GII Research: Sprycel Market, By Application (Chronic myeloid leukemia ...)[3].
4. Coherent Market Insights: Sprycel Market Size & Share Analysis - Industry Research Report[4].