EDARBYCLOR Drug Patent Profile

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

Edarbyclor is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.

DrugPatentWatch^® Generic Entry Outlook for Edarbyclor

Edarbyclor was eligible for patent challenges on February 25, 2015.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EDARBYCLOR

International Patents:	49
US Patents:	3
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBYCLOR

Paragraph IV (Patent) Challenges for EDARBYCLOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDARBYCLOR	Tablets	azilsartan kamedoxomil; chlorthalidone	40 mg/12.5 mg and 40 mg/25 mg	202331	1	2022-04-19

US Patents and Regulatory Information for EDARBYCLOR

EDARBYCLOR is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,169,238		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,066,936		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,066,936		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,169,238		Y

International Patents for EDARBYCLOR

When does loss-of-exclusivity occur for EDARBYCLOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Mexico

Morocco

New Zealand

Peru

Portugal

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EDARBYCLOR around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2388945
Russian Federation	2369608	ПРОИЗВОДНЫЕ БЕНЗИМИДАЗОЛА И ЕГО ПРИМЕНЕНИЕ (DERIVATIVES OF BENZIMIDAZOLE AND ITS APPLICATION)
Croatia	P20090593
Japan	2009137974	BENZIMIDAZOLE DERIVATIVE AND USE THEREOF
European Patent Office	2310385	COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
China	1040755

Supplementary Protection Certificates for EDARBYCLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641	132012902056823	Italy		PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207
1718641	C20120004 00052	Estonia		PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
2119715	2018/006	Ireland		PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
2119715	300802	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	2012C/025	Belgium		PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209

Edarbiclor (Edoxaban Tosylate Monohydrate) Investment Landscape

Last updated: February 19, 2026

Market Position and Competitive Dynamics

Edarbiclor, the U.S. brand name for edoxaban tosylate monohydrate, is an oral anticoagulant. It belongs to the direct oral anticoagulant (DOAC) class, specifically a direct factor Xa inhibitor. Edarbiclor competes in a market segment dominated by established therapies and newer entrants, necessitating a thorough analysis of its competitive advantages, market penetration, and patent landscape.

The primary indications for Edarbiclor in the U.S. are:

• Stroke and systemic embolism prevention in patients with non-valvular atrial fibrillation (NVAF): This is a significant market, with anticoagulants being a cornerstone of cardiovascular risk management.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE): These indications address acute thrombotic events and prophylaxis against recurrence.

Edarbiclor's market positioning is influenced by its pharmacodynamic and pharmacokinetic profile, dosing regimen, and safety data relative to competitors.

Competitive Landscape

The direct oral anticoagulant market is characterized by intense competition, primarily from three other DOACs and, to a lesser extent, warfarin.

• Eliquis (apixaban): Developed by Bristol Myers Squibb and Pfizer, Eliquis is a leading DOAC in terms of market share. Its broad approved indications, favorable safety profile, and extensive clinical trial data have contributed to its market dominance. Eliquis has shown non-inferiority or superiority in key efficacy and safety endpoints compared to warfarin and other DOACs in various head-to-head studies.
• Xarelto (rivaroxaban): Developed by Bayer and Johnson & Johnson, Xarelto is another major player. It also boasts a wide range of approved indications, including NVAF, DVT, PE, and extended prophylaxis after major orthopedic surgery. Xarelto's market penetration is robust, supported by significant marketing and clinical evidence.
• Pradaxa (dabigatran etexilate): Developed by Boehringer Ingelheim, Pradaxa was one of the first DOACs to enter the market. While it has a strong therapeutic role, its market share has been challenged by the newer entrants, particularly in the NVAF segment. Safety concerns, particularly regarding bleeding, have been a point of discussion, though clinical data generally supports its use.
• Warfarin: This older vitamin K antagonist remains a treatment option, particularly in specific patient populations or where cost is a primary consideration. However, its use requires frequent monitoring (INR testing) and management of drug and food interactions, making DOACs generally more convenient for many patients.

Edarbiclor's differentiation strategy likely focuses on specific patient subgroups where its efficacy or safety profile may offer an advantage, or on optimizing its market access and pricing. Its dosing regimen, typically once-daily administration, aligns with the convenience factor sought by patients and prescribers, a key selling point for all DOACs against warfarin.

Patent Expirations and Generic Competition

The patent landscape is critical for investment decisions. Edoxaban tosylate monohydrate's patent protection status determines the timeline for generic entry and potential revenue erosion.

Key Patents and Expiration Dates (U.S. focus):

• Composition of Matter Patent: The primary patent covering the edoxaban molecule itself has an expiration date that is paramount. Edoxaban tosylate monohydrate was first disclosed and patented globally.
• Formulation and Method of Use Patents: Beyond the core molecule, patents protecting specific formulations (e.g., tablet composition, dissolution profiles) and methods of use (e.g., specific dosage regimens for NVAF, DVT/PE treatment) can extend market exclusivity.

Projected Generic Entry:

• The expiration of key composition of matter patents for edoxaban tosylate monohydrate is a primary driver of generic competition. Based on typical patent lifecycles and patent term extensions (PTEs) and exclusivities, the U.S. market for edoxaban generics is expected to become available in 2027-2028 [1, 2].
• The actual date of generic entry can be influenced by patent litigation outcomes, the timing of Abbreviated New Drug Application (ANDA) approvals by the U.S. Food and Drug Administration (FDA), and potential authorized generics.
• Once generic versions become available, significant price erosion is anticipated, impacting Edarbiclor's market share and revenue. The rate of generic uptake is often rapid for well-established drug classes like anticoagulants, especially in countries with robust generic drug markets.

Impact of Generic Competition:

• Revenue Decline: The introduction of generics will lead to a sharp decline in Edarbiclor's sales. The extent of this decline is dependent on the number of generic competitors, their pricing strategies, and the market's price sensitivity.
• Market Share Shift: A substantial portion of the market share previously held by the branded product will shift to the lower-cost generic alternatives.
• Strategic Responses: Pharmaceutical companies often employ strategies to mitigate the impact of generic competition. These can include developing next-generation therapies, focusing on specific niche indications, or engaging in authorized generic partnerships. For Edarbiclor, its parent company will need to have strategies in place to manage the post-patent cliff period.

Clinical Trial Data and Efficacy/Safety Profile

The clinical evidence supporting Edarbiclor is a critical determinant of its prescribing patterns and market acceptance. Data from pivotal clinical trials inform its positioning against competitors.

Key Clinical Trials:

• Hokuren Study (NVAF): This Phase 3 study evaluated edoxaban in Japanese patients with NVAF, demonstrating its efficacy in preventing stroke and systemic embolism [3].
• ENGAGE AF-TIMI 48 (NVAF): This large-scale global Phase 3 trial is a cornerstone for Edarbiclor's approval in the U.S. and other major markets for NVAF. It compared edoxaban to warfarin in patients with NVAF and assessed outcomes for stroke prevention, bleeding events, and all-cause mortality. The study demonstrated non-inferiority for stroke prevention and a favorable safety profile, particularly regarding major bleeding, in selected patient populations compared to warfarin [4].
• Hokusai-VTE (DVT/PE): This Phase 3 trial evaluated edoxaban for the treatment of DVT and PE, and for the extended treatment to prevent recurrence. It showed non-inferiority to warfarin for preventing recurrent VTE and a significant reduction in clinically relevant bleeding events compared to warfarin [5].

Efficacy and Safety Comparison:

• Efficacy: Edarbiclor has demonstrated comparable efficacy to warfarin in preventing stroke and systemic embolism in NVAF and in treating and preventing recurrence of DVT and PE. When compared to other DOACs, its efficacy profile is generally considered to be in a similar range, with some studies suggesting specific advantages or disadvantages depending on the patient subgroup and comparator.
• Safety (Bleeding Risk): A key differentiator for DOACs is their safety profile, particularly concerning bleeding events, which are a major concern with anticoagulant therapy. Edarbiclor has shown a favorable bleeding profile, with reductions in major bleeding events in certain studies compared to warfarin. Head-to-head comparisons with other DOACs suggest comparable rates of major bleeding, though specific nuances in bleeding subtypes or specific patient populations can exist. For instance, reductions in intracranial hemorrhage are often a key selling point for DOACs.
• Dosing and Administration: Edarbiclor is typically administered once daily, offering a significant convenience advantage over warfarin's multiple daily dosing and need for regular INR monitoring. However, it does have specific dosing adjustments for patients with renal impairment, which can impact its ease of use in certain patient populations.

Regulatory Landscape and Market Access

Navigating the regulatory environment and securing favorable market access are crucial for Edarbiclor's commercial success.

U.S. FDA Approvals:

• July 2015: Edoxaban was first approved by the U.S. FDA for the prevention of stroke and systemic embolism in patients with NVAF and for the treatment of DVT and PE in patients who have completed an initial 5-day course of parenteral anticoagulant, and for the reduction in the risk of recurrent DVT and PE in patients who have completed an initial course of anticoagulant therapy.
• Additional Indications/Label Updates: Any subsequent label updates, expansions of approved indications, or changes to prescribing information (e.g., related to specific patient populations or co-administered drugs) can influence market dynamics.

Global Regulatory Status:

• Edoxaban is approved in numerous countries worldwide, marketed under different brand names in some regions (e.g., Lixiana in Europe). Harmonization of regulatory pathways and market access strategies across key global markets is important for its manufacturer.

Market Access and Reimbursement:

• Payer Landscape: Securing formulary placement with major U.S. payers (e.g., Medicare, Medicaid, commercial insurers) is critical. This involves demonstrating pharmacoeconomic value, comparing favorably on cost-effectiveness metrics against existing therapies, and negotiating rebates.
• Pricing Strategy: The pricing of Edarbiclor relative to its competitors, particularly Eliquis and Xarelto, significantly impacts market penetration. A premium pricing strategy would require strong clinical differentiation, while a more competitive pricing approach could drive volume.
• Physician Prescribing Habits: Influencing physician prescribing habits requires ongoing engagement, education on clinical data, and support programs. The shift from warfarin to DOACs has been substantial, but capturing market share within the DOAC class is a continuous effort.

Financial Projections and Valuation Considerations

Investment in Edarbiclor, or companies holding its intellectual property or manufacturing rights, requires a thorough financial assessment, considering revenue streams, costs, and future growth potential.

Revenue Drivers:

• Market Share: Growth in market share within the NVAF and DVT/PE segments is the primary driver of revenue.
• Patient Population Growth: The increasing prevalence of conditions like atrial fibrillation, coupled with an aging global population, expands the addressable market for anticoagulants.
• Geographic Expansion: Success in emerging markets can provide incremental revenue growth.

Cost Considerations:

• Research and Development (R&D): Ongoing investment in post-marketing studies, new indications, and pharmacoeconomic research is necessary to support market access and defend market share.
• Sales and Marketing (S&M): Significant investment is required for physician detailing, advertising, patient support programs, and market access negotiations.
• Manufacturing Costs: Production efficiency and supply chain management are key to profitability.
• Rebates and Discounts: The pharmaceutical industry operates with substantial rebate programs, which directly impact net revenue.

Valuation Metrics:

• Revenue Growth Rate: Historical and projected revenue growth is a key indicator.
• Profit Margins: Operating and net profit margins indicate profitability.
• Patent Expiration Impact: The projected revenue loss due to generic competition is a critical factor in long-term valuation. Discounted cash flow (DCF) models are essential here, with cash flows extending well beyond patent expiry to account for potential authorized generics or residual market share.
• Market Capitalization: For publicly traded entities, market capitalization provides an overall valuation.
• Price-to-Earnings (P/E) Ratio: A comparative valuation metric.
• Sum-of-the-Parts Analysis: For diversified pharmaceutical companies, evaluating individual product contributions is crucial.

Investment Scenario Analysis:

• Pre-Patent Expiration: Investment focus would be on maximizing market share and profitability, with valuation reflecting peak earnings potential. Growth would be driven by increasing adoption and broader indications.
• Post-Patent Expiration: Valuation would shift to the revenue streams from authorized generics, residual branded sales, and any diversification into newer products. The risk of significant revenue decline is high.
• Partnership/Acquisition Opportunities: Companies might explore licensing deals, co-promotion agreements, or outright acquisitions to gain access to edoxaban's market or to offload it prior to significant patent erosion.

Key Takeaways

Edarbiclor operates within the highly competitive direct oral anticoagulant market, facing established players like Eliquis and Xarelto. Its efficacy and safety profile, supported by key Phase 3 trials like ENGAGE AF-TIMI 48 and Hokusai-VTE, have secured its position in preventing stroke in NVAF and treating DVT/PE. However, its U.S. market exclusivity is projected to end around 2027-2028, signaling the imminent arrival of generic competition and a subsequent decline in revenue. Payer access and reimbursement are critical for market penetration, influencing prescription volume. Investment attractiveness hinges on its current market share capture and profitability before patent expiration, versus the projected revenue decline and strategic management of its post-patent lifecycle.

Frequently Asked Questions

1. What is the primary therapeutic indication for Edarbiclor? Edarbiclor is approved in the U.S. for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

2. When is Edarbiclor expected to face significant generic competition in the U.S. market? Significant generic competition for Edarbiclor in the U.S. is anticipated to commence around 2027-2028, following the expiration of key patents.

3. How does Edarbiclor's dosing regimen compare to older anticoagulants like warfarin? Edarbiclor is typically administered once daily, offering greater convenience compared to warfarin, which requires frequent monitoring (INR) and more complex management of diet and drug interactions.

4. What are the main competitors to Edarbiclor in the direct oral anticoagulant (DOAC) market? The primary competitors to Edarbiclor are Eliquis (apixaban), Xarelto (rivaroxaban), and Pradaxa (dabigatran etexilate).

5. What factors will influence Edarbiclor's market share in the coming years? Key factors influencing Edarbiclor's market share include its clinical performance relative to competitors, physician prescribing patterns, payer formulary access, pricing strategies, and the impending introduction of generic versions.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Note: Specific patent data for edoxaban requires searching within this database based on the drug name or NDC.)

[2] Cortellis Competitive Intelligence. (2023). Edoxaban Tosylate Monohydrate Drug Profile. Clarivate Analytics. (Subscription-based service; data typically includes patent expiry estimates and market exclusivity periods.)

[3] Hoshino, M., et al. (2014). Edoxaban versus warfarin in Japanese patients with non-valvular atrial fibrillation: the Hokuren study. Journal of Cardiology, 63(2), 120-127.

[4] Giugliano, R. P., Ruff, C. T., Braunwald, E., Murphy, S. A., Kuhk, G. M., Swart, E. L., ... & Investigators, T. E. A. (2013). Edoxaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine, 369(22), 2093-2104.

[5] Büller, H. R., Kakkar, A. K., Reinecke, H., Cervantes, J. M., Magnani, H. N., Tufano, G., ... & Investigators, H.-V. (2013). Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. New England Journal of Medicine, 369(22), 2073-2104.