DABIGATRAN ETEXILATE MESYLATE - Generic Drug Details

What are the generic sources for dabigatran etexilate mesylate and what is the scope of patent protection?

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, MSN, and Boehringer Ingelheim, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dabigatran etexilate mesylate has one hundred and twenty patent family members in forty-four countries.

There are twenty-four drug master file entries for dabigatran etexilate mesylate. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for DABIGATRAN ETEXILATE MESYLATE

International Patents:	120
US Patents:	2
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	6
Patent Applications:	264
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DABIGATRAN ETEXILATE MESYLATE
What excipients (inactive ingredients) are in DABIGATRAN ETEXILATE MESYLATE?	DABIGATRAN ETEXILATE MESYLATE excipients list
DailyMed Link:	DABIGATRAN ETEXILATE MESYLATE at DailyMed

Recent Clinical Trials for DABIGATRAN ETEXILATE MESYLATE

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

Sponsor	Phase
Daiichi Sankyo Co., Ltd.	Early Phase 1
Mayo Clinic	Phase 1
Huons Co.,Ltd.	Phase 1

See all DABIGATRAN ETEXILATE MESYLATE clinical trials

Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE

Applicant	Application No.	Strength	Dosage Form
		150MG	CAPSULE;ORAL
		110MG	CAPSULE;ORAL
		EQ 150MG BASE	CAPSULE;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 DABIGATRAN ETEXILATE MESYLATE

Drug Class	Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Medical Subject Heading (MeSH) Categories for DABIGATRAN ETEXILATE MESYLATE

Antithrombins

Anatomical Therapeutic Chemical (ATC) Classes for DABIGATRAN ETEXILATE MESYLATE

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for DABIGATRAN ETEXILATE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRADAXA	Capsules	dabigatran etexilate mesylate	eq. to 110 mg base	022512	2	2015-12-15
PRADAXA	Capsules	dabigatran etexilate mesylate	eq. to 75 mg base and 150 mg base	022512	17	2014-10-20

US Patents and Regulatory Information for DABIGATRAN ETEXILATE MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-002	Mar 11, 2020	AB	RX	No	No
Msn	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	213879-001	May 22, 2024	AB	RX	No	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010	AB	RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No
Msn	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	213879-003	Aug 12, 2024	AB	RX	No	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-001	Jun 21, 2021		RX	Yes	No

International Patents for DABIGATRAN ETEXILATE MESYLATE

Country	Patent Number	Title	Estimated Expiration
Colombia	6571889	Antidotos anticoagulantes
Spain	2614992
Japan	5575923
Cyprus	1109299
Spain	2326654
Tunisia	2012000366	ANTICOAGULANT ANTIDOTES
South Africa	201202876	ANTICOAGULANT ANTIDOTES

Supplementary Protection Certificates for DABIGATRAN ETEXILATE MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0966454	C00966454/01	Switzerland		PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
1485094	C300560	Netherlands		PRODUCT NAME: DABIGATRAN-ETEXILAAT, DESGEWENST IN DE VORM VAN EEN ZOUT-IN HET BIJZONDER DABIGATRAN-ETEXILAAT-MESYLAAT; REGISTRATION NO/DATE: EU/1/08/442/009-014 20110801
1870100	CA 2012 00027	Denmark		PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318
2525812	2017034	Norway		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124
1485094	CA 2012 00054	Denmark		PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
2525812	PA2017021,C2525812	Lithuania		PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
2525812	C20170024 00247	Estonia		PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015

DABIGATRAN ETEXILATE MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dabigatran Etexilate Mesylate

Introduction to Dabigatran Etexilate Mesylate

Dabigatran etexilate mesylate, marketed under the brand name Pradaxa, is a synthetic, non-peptide, competitive oral direct thrombin inhibitor (DTI). It is used primarily for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis and pulmonary embolism[2][3].

Market Size and Growth Projections

The global dabigatran etexilate mesylate market has experienced significant growth in recent years and is projected to continue this upward trend. The market size is expected to expand substantially from 2023 to 2031, with a compound annual growth rate (CAGR) that indicates robust growth rates over the forecast period[1][5].

Segmentation of the Market

The market is segmented based on several key factors:

• Type: The market is categorized into purity levels, such as purity ≥99% and purity <99%[1].
• Application: The primary applications include capsules and other forms. The capsule form is the most prevalent due to its ease of administration and bioavailability[1][5].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth dynamics influenced by local healthcare policies, patient demographics, and market penetration[1][5].

Drivers of Market Growth

Several factors are driving the growth of the dabigatran etexilate mesylate market:

• Increasing Prevalence of Atrial Fibrillation: The rising incidence of atrial fibrillation, particularly among the aging population, is a significant driver. As the global population ages, the demand for effective anticoagulants like dabigatran etexilate mesylate is expected to increase[5].
• Clinical Efficacy: Studies, such as the RE-LY trial, have demonstrated the superior efficacy and favorable risk-benefit profile of dabigatran etexilate mesylate compared to traditional anticoagulants like warfarin[2][3].
• Real-World Data: Real-world data analyses have shown that patients treated with Pradaxa experience fewer hospitalizations, emergency room visits, and physician office visits, which supports its widespread adoption[3].

Restraints and Challenges

Despite the positive growth trajectory, there are several challenges that the market faces:

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring of safety and efficacy can slow market growth. Regulatory changes and compliance issues can also impact the market dynamics[5].
• Cost and Accessibility: The high cost of dabigatran etexilate mesylate compared to some traditional anticoagulants can limit its accessibility in certain regions, particularly in developing countries[5].
• Side Effects and Safety Concerns: Like all anticoagulants, dabigatran etexilate mesylate carries risks of bleeding and other side effects, which can affect patient compliance and overall market growth[2].

Opportunities and Trends

The market presents several opportunities and trends that are shaping its future:

• Technological Advancements: Continuous technological advancements in drug formulation and delivery systems can enhance the bioavailability and safety profile of dabigatran etexilate mesylate, making it more appealing to patients and healthcare providers[5].
• Expanding Indications: Research into new indications for dabigatran etexilate mesylate, such as the treatment of other thromboembolic conditions, could expand its market reach[2].
• Generic Competition: The potential entry of generic versions of dabigatran etexilate mesylate could increase competition and drive down prices, making the drug more accessible to a broader patient population[5].

Competitive Landscape

The market for dabigatran etexilate mesylate is dominated by Boehringer Ingelheim, the original developer and marketer of Pradaxa. However, as patents expire, other pharmaceutical companies are likely to enter the market with generic versions, increasing competition and potentially altering market dynamics[1][5].

Financial Performance and Projections

The financial performance of the dabigatran etexilate mesylate market is robust, with significant revenue growth anticipated over the forecast period. Here are some key financial highlights:

• Market Size: The global market size for dabigatran etexilate mesylate was substantial in 2023 and is projected to grow at a notable CAGR from 2024 to 2031[1][5].
• Revenue Share: The market revenue is expected to be distributed across various regions, with North America and Europe being significant contributors due to their well-established healthcare systems and high patient awareness[1][5].

Regional Analysis

The market performance varies by region:

• North America: This region is expected to remain a major market due to high healthcare spending and a large patient population with atrial fibrillation[1][5].
• Europe: Europe also represents a significant market, driven by advanced healthcare infrastructure and regulatory support for innovative drugs[1][5].
• Asia-Pacific: This region is expected to grow rapidly due to increasing healthcare expenditure and a large patient base, particularly in countries like China and India[1][5].

Key Players and Their Strategies

Boehringer Ingelheim is the primary player in the market, but other companies are also focusing on this segment:

• Boehringer Ingelheim: The company continues to invest in real-world data analyses and clinical trials to support the efficacy and safety of Pradaxa. It also engages in strategic partnerships to expand its market reach[3].
• Other Pharmaceutical Companies: As the market opens up to generic competition, other companies are likely to enter with their own versions of dabigatran etexilate mesylate, which could lead to increased competition and potentially lower prices[5].

Technological Roadmap and Innovation

The market is driven by continuous innovation in drug formulation, delivery systems, and manufacturing processes. Here are some key technological trends:

• Improved Formulations: Research into new formulations that enhance bioavailability and reduce side effects is ongoing. This could lead to more patient-friendly versions of the drug[5].
• Manufacturing Efficiency: Advances in manufacturing processes are aimed at reducing production costs and improving the quality of the final product[5].

Environmental and Safety Regulations

Environmental and safety regulations play a crucial role in shaping the market:

• Regulatory Compliance: Companies must comply with stringent regulatory requirements related to the production, packaging, and disposal of pharmaceuticals. This includes adherence to Good Manufacturing Practices (GMP) and environmental safety standards[5].

Consumer Behavior and Market Attractiveness

Consumer behavior and market attractiveness are critical factors in the growth of the dabigatran etexilate mesylate market:

• Patient Preferences: Patients are increasingly seeking drugs with better safety profiles and fewer side effects. Dabigatran etexilate mesylate, with its favorable risk-benefit profile, is attractive to patients and healthcare providers[3].
• Market Attractiveness: The market attractiveness is high due to the growing demand for anticoagulants, the expanding indications for dabigatran etexilate mesylate, and the potential for generic competition to increase accessibility[5].

Porter's Five Forces Analysis

A Porter's Five Forces analysis provides insights into the competitive landscape:

• Threat of New Entrants: The threat of new entrants is moderate due to the presence of strong intellectual property rights and regulatory barriers[5].
• Bargaining Power of Suppliers: The bargaining power of suppliers is relatively low due to the availability of multiple raw material suppliers[5].
• Bargaining Power of Buyers: The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and the cost sensitivity of patients[5].
• Threat of Substitute Products: The threat of substitute products is high due to the presence of other anticoagulants and the potential for new drugs to enter the market[5].
• Competitive Rivalry Among Existing Competitors: The competitive rivalry is expected to increase with the entry of generic versions and other new drugs[5].

SWOT Analysis

A SWOT analysis highlights the strengths, weaknesses, opportunities, and threats of the market:

• Strengths: Strong clinical efficacy, favorable risk-benefit profile, and established market presence[3].
• Weaknesses: High cost, potential side effects, and regulatory challenges[5].
• Opportunities: Expanding indications, technological advancements, and increasing demand for anticoagulants[5].
• Threats: Generic competition, regulatory changes, and the emergence of new drugs[5].

Key Takeaways

• The dabigatran etexilate mesylate market is expected to grow significantly from 2023 to 2031.
• The market is driven by increasing prevalence of atrial fibrillation, clinical efficacy, and real-world data supporting its use.
• Regulatory hurdles, cost, and safety concerns are key challenges.
• Technological advancements and expanding indications offer significant opportunities.
• The competitive landscape is expected to become more dynamic with the entry of generic versions.

Frequently Asked Questions (FAQs)

Q1: What is dabigatran etexilate mesylate used for? Dabigatran etexilate mesylate is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism[2][3].

Q2: What are the key drivers of the dabigatran etexilate mesylate market? The key drivers include the increasing prevalence of atrial fibrillation, superior clinical efficacy compared to traditional anticoagulants, and supportive real-world data[3][5].

Q3: What are the main challenges facing the dabigatran etexilate mesylate market? The main challenges include regulatory hurdles, high cost, potential side effects, and the emergence of generic competition[5].

Q4: How is the competitive landscape of the dabigatran etexilate mesylate market expected to evolve? The competitive landscape is expected to become more dynamic with the entry of generic versions of dabigatran etexilate mesylate, increasing competition and potentially altering market dynamics[5].

Q5: What technological trends are shaping the dabigatran etexilate mesylate market? Technological trends include improvements in drug formulation, delivery systems, and manufacturing processes aimed at enhancing bioavailability, reducing side effects, and lowering production costs[5].

Citations

1. Market Research Intellect: Global Dabigatran Etexilate Mesylate API Market Size, Trends and Forecasts.
2. FDA: Clinical Pharmacology and Biopharmaceutics Review of Dabigatran Etexilate Mesylate.
3. Innovations in CRM: New Real-World Data Show Pradaxa® (dabigatran etexilate mesylate) Treatment.
4. Dataintelo: Global Dabigatran Etexilate Mesylate Market.
5. Cognitive Market Research: Dabigatran Etexilate Mesylate Market Report 2024 (Global Edition).