EDARBYCLOR Drug Patent Profile

When do Edarbyclor patents expire, 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. One supplier is 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 eleven 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	22
Drug Prices:	Drug price information for EDARBYCLOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBYCLOR
What excipients (inactive ingredients) are in EDARBYCLOR?	EDARBYCLOR excipients list
DailyMed Link:	EDARBYCLOR at DailyMed

See drug prices for EDARBYCLOR

Recent Clinical Trials for EDARBYCLOR

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

Sponsor	Phase
Takeda	Phase 3

See all EDARBYCLOR clinical trials

Pharmacology for EDARBYCLOR

Drug Class	Angiotensin 2 Receptor Blocker Thiazide-like Diuretic
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure Increased Diuresis

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

Expired US Patents for EDARBYCLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,157,584
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	5,583,141
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,736,555
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	7,157,584

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
Austria	240323
Australia	1859892
Australia	646343
Canada	2072541	COMPOSES HETEROCYCLIQUES, PRODUCTION ET UTILISATION (HETEROCYCLIC COMPOUNDS, THEIR PRODUCTION AND USE)

Supplementary Protection Certificates for EDARBYCLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C300525	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
1718641	PA2012004	Lithuania		PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207
1718641	CA 2012 00013	Denmark
1718641	91962	Luxembourg		91962, EXPIRES: 20261207

EDARBYCLOR (azilsartan medoxomil/chlorthalidone) market dynamics and financial trajectory (US focus, patent-led outlook)

Last updated: July 30, 2026

EDARBYCLOR (azilsartan medoxomil/chlorthalidone) has a niche US position in hypertension, with commercial performance constrained by (1) limited payer adoption versus cheaper combination regimens and (2) patent and exclusivity windows that have become less protective over time. The near-to-mid term revenue trajectory is primarily driven by generic erosion risk in the US, channel inventory cycles, and how aggressively competitors bundle or price against ARB plus thiazide-like combinations.

What is EDARBYCLOR’s commercial positioning in hypertension?

EDARBYCLOR is an ARB/thiazide-type fixed-dose combination for hypertension: azilsartan medoxomil plus chlorthalidone. In practice, its adoption depends on whether payers prefer ARB-thiazide fixed-dose regimens and whether clinicians accept azilsartan’s formulary placement relative to more established ARBs and generic-first competitors.

US payer and formulary dynamics

Key determinants of market share

• Net price vs. generics of ARB and chlorthalidone: ARB monotherapies and generic fixed-dose combinations exert pricing pressure on newer branded combinations.
• Formulary tiering: EDARBYCLOR’s access improves when it is placed on preferred tiers for patients inadequately controlled on monotherapy or separate agents.
• Step edits and prior authorization: Hypertension plans often use step edits. Fixed-dose combinations can face tighter controls if cheaper multi-pill regimens exist.

Competitive landscape for ARB + thiazide combinations

EDARBYCLOR competes with a large set of ARB-thiazide fixed-dose products and the clinical reality of prescribing equivalent generic components separately. In such categories, branded combination growth typically stalls unless pricing and outcomes support formulary differentiation.

How has EDARBYCLOR’s financial trajectory evolved since launch?

EDARBYCLOR’s financial path follows a pattern common to ARB fixed-dose combinations entering a market that becomes increasingly generic and rebate-driven: early adoption, then gradual decline or stagnation unless protected by strong patent barriers and sustained differentiated contracting.

Revenue drivers and headwinds

Primary revenue drivers

• Increased utilization of fixed-dose combination therapy among patients moving from monotherapy to combination treatment.
• Prescriber confidence in ARB efficacy plus chlorthalidone’s cost and potency in lowering BP.

Primary headwinds

• Erosion from generic ARB tablets and generic chlorthalidone, plus cheaper fixed-dose generics.
• Rebate pressure as payers rationalize formularies to fewer branded SKUs.
• Limited ability to sustain premium pricing once generic alternatives expand.

What typically explains branded ARB-combo declines

• Patent cliffs and “first generic” timing: Once a generic fixed-dose combination can enter, payer substitution accelerates.
• PBM contracting changes: Net-to-gross compresses when a branded product loses preferred status or faces harder utilization management.

(Commercial performance figures are not provided in the sources required for a quantified revenue trajectory here.)

What patents protect EDARBYCLOR and how does the estate affect pricing power?

For ARB fixed-dose combinations, the effective exclusivity period depends on (1) drug substance or salts claims, (2) fixed-dose composition claims, and (3) method-of-use claims, plus (4) device or formulation-specific manufacturing claims where applicable.

What patent holders control key exclusivity levers?

EDARBYCLOR’s exclusivity and litigation posture are determined by the assignees holding:

• azilsartan medoxomil-related intellectual property
• chlorthalidone combination-specific composition claims
• formulation and manufacturing/process claims that can be asserted against generic applicants

Estate impact on financial trajectory

• Longer remaining patent life supports higher net pricing and slower generic substitution.
• When the remaining claims are narrow, generic launch risk increases and net pricing deteriorates earlier through contracting.

How do composition vs. method-of-use claims change generic entry timing?

• Composition-only protection tends to be easier for challengers to design around or to anticipate with “carve-outs” in label and formulation.
• Method-of-use claims can delay full therapeutic substitution if generic labeling is constrained, though real-world substitution still often proceeds off-label or through switching patterns governed by payer rules.

When does EDARBYCLOR lose exclusivity and what generic entry risks exist?

Exclusivity loss mechanics

• Patent expiration enables generic design-around only if remaining claims do not cover the generic product.
• Regulatory exclusivity (if applicable) can delay approval, but fixed-dose combination products typically rely heavily on patent coverage rather than long periods of regulatory exclusivity.

Generic entry risk profile

• If the US patent estate has weak composition claims at the time of challenge, Paragraph IV filings can precipitate market share losses via early generic approvals and subsequent switching.
• If remaining claims are enforceable and likely to be upheld, litigation settlements can extend market protection via delayed launch or authorized-generic arrangements.

(Exact expiration dates and Paragraph IV events are not listed in the provided source material required for a complete and accurate timeline.)

What is the Orange Book status of EDARBYCLOR and what listings matter for investors?

Orange Book status governs the legal landscape for FDA approval pathways:

• If EDARBYCLOR lists multiple patents tied to the approved combination product, challengers must address each listed patent to obtain a favorable approval position.
• Investors focus on whether patents are still listed as “expiration” distant versus near-term.

What to look for in the Orange Book for EDARBYCLOR

• Patent types: composition, method of use, and process.
• Whether patents are listed as expiring before or after key timepoints for potential generic approval.
• Whether patents are “listed for the drug product” versus “listed for the active ingredient(s),” affecting the probability of successful challenges.

(Orange Book listing data is not included in the sources required for a complete and accurate EDARBYCLOR-specific Orange Book table.)

Which companies have the highest competitive impact on EDARBYCLOR’s revenue?

Competitors likely exert the largest impact through:

• Lower-cost generics using ARB plus chlorthalidone components.
• Branded or quasi-branded fixed-dose combinations with better payer access and lower net pricing.
• PBM contracting leverage that favors products with broader formulary coverage.

In fixed-dose hypertension markets, the largest financial impact generally comes from:

1. generic entrants of the exact fixed-dose combination and
2. generic substitution at the component level.

(Company-level data is not provided in the required sources for an accurate EDARBYCLOR-specific competitor mapping.)

What patent litigation and Paragraph IV challenges affect EDARBYCLOR?

Paragraph IV litigation affects EDARBYCLOR economics via:

• potential early generic launch after a court decision
• settlements that delay entry
• reputational and contracting consequences even before launch if payers anticipate generic availability

What litigation milestones typically move the needle

• filing of a Paragraph IV ANDA
• court rulings on claim validity or infringement
• settlement agreements and permitted launch dates
• FDA approval date for the first generic

(Actual litigation captions, dates, and outcomes for EDARBYCLOR are not provided in the sources required for a complete and accurate report.)

How does EDARBYCLOR compare with other ARB + thiazide fixed-dose therapies?

A credible competitive comparison centers on:

• Dosing flexibility and titration range
• Formulary access and rebate structure
• Outcome data and patient tolerability (eg, electrolyte abnormalities and BP response patterns)
• Switchability: whether payers can substitute within the ARB-thiazide class without medical exceptions

Likely comparative advantages and disadvantages

Potential advantages

• Fixed-dose adherence benefits.
• Clinician familiarity with ARB efficacy plus chlorthalidone effect.

Likely disadvantages

• Premium pricing pressure versus generic component regimens.
• Contracting disadvantage if alternatives secure preferred tiers.

What formulations and dosage strengths drive EDARBYCLOR demand?

EDARBYCLOR demand typically concentrates in:

• commonly prescribed dose strengths aligned with titration pathways in guidelines
• strengths with better insurance coverage or lower copays under plan design

Manufacturing and product continuity considerations

Generic challengers also evaluate:

• stability and bioequivalence feasibility for fixed-dose combinations
• ability to source consistent active ingredient quality for combination tablets

Product continuity affects branded supply reliability, which in turn affects payer trust and formulary stickiness.

What commercial metrics should be used to track EDARBYCLOR’s financial trajectory?

For EDARBYCLOR, investors and operating teams typically monitor:

• Script share in ARB-thiazide fixed-dose combinations
• Average net price and rebate rate trends
• PBM formulary status shifts and utilization management changes
• First generic timing impact on switching curves
• Inventory levels and wholesaler buy-in behavior

Key Takeaways

• EDARBYCLOR’s market dynamics are dominated by hypertension payer behavior and the financial pressure from generic ARB and chlorthalidone availability.
• The product’s revenue trajectory depends more on US patent and Orange Book coverage than on incremental clinical differentiation once formulary access is achieved.
• Mid-term financial outlook is sensitive to the timing of generic entry and the presence or absence of enforceable, combination-relevant patents.
• Tracking script share, net price, formulary tiering, and any Paragraph IV or settlement milestones is the most direct way to forecast revenue direction.

FAQs

1. What FDA pathway supports generic azilsartan medoxomil/chlorthalidone fixed-dose combination products?
2. How do formulary step edits change EDARBYCLOR switching from ARB monotherapy?
3. Do method-of-use patents for ARB-thiazide combinations delay generic substitution in real-world dispensing?
4. What is the typical impact on net sales when a branded ARB fixed-dose combination loses preferred PBM status?
5. How should investors model revenue risk after the first authorized generic of an ARB-thiazide fixed-dose combination launches?

References (APA)

1. (No citable source material was provided in the prompt.)

DrugChatter Q&A for EDARBYCLOR

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