EDARBI Drug Patent Profile

Which patents cover Edarbi, and what generic alternatives are available?

Edarbi is a drug marketed by Azurity and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in seventeen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Edarbi

Edarbi 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 EDARBI

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	16
Patent Applications:	425
Drug Prices:	Drug price information for EDARBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBI
What excipients (inactive ingredients) are in EDARBI?	EDARBI excipients list
DailyMed Link:	EDARBI at DailyMed

See drug prices for EDARBI

Recent Clinical Trials for EDARBI

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

Sponsor	Phase
Gedeon Richter Plc.	PHASE1
Takeda
Takeda	Phase 1

See all EDARBI clinical trials

Pharmacology for EDARBI

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for EDARBI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDARBI	Tablets	azilsartan kamedoxomil	40 mg and 80 mg	200796	1	2020-04-10

US Patents and Regulatory Information for EDARBI

EDARBI is protected by one 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	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	AB	RX	Yes	No	9,066,936		Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	AB	RX	Yes	Yes	9,066,936		Y

Expired US Patents for EDARBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,736,555
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,958,961

International Patents for EDARBI

When does loss-of-exclusivity occur for EDARBI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

New Zealand

Peru

Portugal

South Korea

Spain

Taiwan

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 EDARBI 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 EDARBI

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

Last updated: July 20, 2026

EDARBI (azilsartan medoxomil): Market dynamics and financial trajectory

EDARBI (azilsartan medoxomil) is a brand of the angiotensin II receptor blocker (ARB) class for hypertension. In the US, EDARBI’s commercial trajectory has shifted from launch-era uptake to sustained decline as newer ARBs and generics expanded and formulary competition tightened. The economic center of gravity now sits on (1) how EDARBI’s residual payer access holds versus low-cost ARB generics and (2) whether any remaining branded pricing power can be defended through late-cycle contracting, bundle positioning, and segment-specific differentiation.

How has EDARBI’s US market share moved since launch?

Short answer: EDARBI’s US share trended down after the class and payer shift toward generic ARBs, with persistent volume retention only where branded differentiation and patient-specific tolerability mattered.

What are the main demand drivers for EDARBI?

• Hypertension incidence and guideline adherence in the ARB segment.
• Formulary placement vs other ARBs (losartan, valsartan, olmesartan, telmisartan).
• Substitution pressure once generic ARBs became standard of care.
• Patient switching patterns driven by side effects, blood pressure control, and co-pay behavior.

What are the main headwinds?

• Margin compression from generic substitution across the ARB class.
• Payer step therapy and preferred-drug lists.
• Competitive switching from branded and non-branded ARBs based on cost and coverage.

What is EDARBI’s financial trajectory (sales) and why did it change?

Short answer: EDARBI’s sales have experienced a multi-year downtrend consistent with ARB generic erosion, with periodic stabilization possible only during contract cycles or localized payer access.

Which product levers affected EDARBI revenue?

• Net pricing under rebate pressure (especially after broader generic penetration).
• Channel mix (retail vs mail) and plan sponsor behavior.
• Dose mix (20 mg, 40 mg, 80 mg) and whether higher-dose utilization persisted despite cost pressure.
• Persistence and refill cycles tied to adherence in chronic hypertension.

What structural ARB economics matter for EDARBI?

ARB brands commonly lose commercial economics as soon as generic ARBs become widely used. The branded ARB with the highest contractual intensity (favorable copays, formulary preference) can delay decline. EDARBI’s overall trajectory is consistent with branded ARB late-cycle economics: declining unit volumes offset only partially by any residual pricing advantage.

How does EDARBI compare with other ARBs for payer access and cost competitiveness?

Short answer: EDARBI faces the hardest competition from widely available generic ARBs, especially those with strong formulary “preferred” status.

Comparative competitive set by therapeutic positioning

• Losartan (generic-dominant)
• Valsartan (generic-dominant)
• Olmesartan (generic)
• Telmisartan (generic)
• Other branded ARBs in some markets (relevant only if formulary access persists)

What changes in payer behavior shift demand away from EDARBI?

• Conversion from “brand-preferred” to “generic-preferred.”
• Step therapy that allows brand only after failure or intolerance.
• Incentive design that pushes prescribers toward generics.

What formulation and dosing market constraints shape EDARBI economics?

Short answer: EDARBI is oral and delivered as azilsartan medoxomil tablets; the market largely treats ARBs as interchangeable, so clinical value arguments must overcome cost and coverage gaps.

Dose structure and reimbursement impact

• EDARBI tablets are typically reimbursed on a per-quantity and plan formulary basis.
• Higher-dose usage can support revenue per patient but does not materially overcome generic substitution dynamics unless coverage favors branded higher doses.

What payer and contracting dynamics govern EDARBI’s late-cycle performance?

Short answer: Late-cycle branded ARB performance depends on rebate intensity, formulary exceptions, and how plan formularies classify “preferred” vs “non-preferred” status for ARBs.

Contracting mechanisms that can stabilize EDARBI volume

• Limited-time preferred positioning within targeted payer segments.
• Patient-specific exception pathways (tolerability or documented inadequate response).
• Copay support where allowed, influencing patient switching at refill.

Contracting mechanisms that accelerate decline

• Removal to non-preferred tier after contracting cycles.
• Broader step therapy with failure criteria before brand initiation.
• Increased generic utilization in chronic maintenance.

What generic entry risks exist for EDARBI and how do they affect revenue?

Short answer: Generic ARB entry dynamics affect EDARBI chiefly through class substitution, not only by direct product-level generic pressure. Once generic ARBs became pervasive, the economic basis for EDARBI branding weakened.

How generic pressure typically hits branded ARBs

• Immediate price erosion as pharmacy benefit managers widen generic use.
• Switch from incident patients to generics at the point of prescribing.
• Later refill attrition when branded supply continues but coverage discourages branded continuation.

What patent estate issues typically drive ARB brand decline like EDARBI?

Short answer: Even when a brand remains on the market, patents usually shift from active exclusivity to narrower protections that do not block generic ARB use for the class indication.

Key estate categories in ARB commercialization

• Composition-of-matter and method-of-use protections (impacting direct generic entry).
• Formulation and dosing patents (sometimes weaker against class switching).
• Enforcement geography (US vs other markets, and Orange Book-listed patent coverage).

No EDARBI-specific patent list, expiration dates, or Orange Book status can be reliably produced in this response because the required patent and listing dataset is not present in the prompt context.

What regulatory status and FDA pathway considerations matter for EDARBI’s market dynamics?

Short answer: For an approved branded tablet with widespread ARB alternatives, regulatory considerations affect market access mainly via how generics file and how interchangeability is handled by payers and pharmacies.

Interchangeability and substitution

• Substitution behavior is largely governed by pharmacy policies and plan formularies rather than clinical pathway changes.
• For chronic antihypertensives, patient stability often matters, but cost coverage usually dominates decision-making at the point of prescribing.

What commercial milestones and events typically move EDARBI revenue quarter to quarter?

Short answer: In late-cycle branded ARBs, quarterly movement is usually driven by contracting cycles, formulary status changes, and rebate adjustments rather than new clinical differentiation.

Events that most often correlate with branded ARB revenue shifts

• PBM formulary changes.
• New national accounts or loss of accounts.
• Switch rate changes due to copay and prior authorization edits.
• Dose-mix changes driven by guideline and prescriber behavior.

Where does EDARBI sit in the ARB competitive landscape today?

Short answer: EDARBI sits as a niche remaining branded ARB where coverage or patient-specific factors support continued use, but the broad ARB market is dominated by generic ARBs on cost and access.

Commercial implications

• Reduced growth profile.
• Higher volatility linked to payer-by-payer policy.
• Lower strategic leverage for new indications due to saturated hypertension market dynamics and generic dominance.

Key Takeaways

• EDARBI’s market dynamics follow the typical branded ARB late-cycle pattern: sustained revenue pressure as generic ARBs and payer formularies favor low-cost options.
• Financial trajectory is driven primarily by net pricing and formulary access rather than product differentiation at the class level.
• Competitive switching is the core risk: once a payer prefers generic ARBs, EDARBI’s volume retention depends on exceptions, tolerability, and contracting outcomes.

FAQs

1. Why do payers restrict branded ARBs like EDARBI even when patients respond well?
   Coverage is optimized for cost-effectiveness in a class where generics are widely available, and prior authorization or step therapy is used to reduce branded substitution.

2. How do copay programs affect EDARBI demand versus generic ARBs?
   Copay support can influence patient and prescriber behavior, but it is constrained by payer rules and can be offset by prior authorization and tiering.

3. What is the main driver of branded ARB sales decline: price or volume?
   Both matter, but volume typically declines faster once formulary preference shifts to generics; price support via rebates then becomes insufficient to fully offset unit erosion.

4. Do higher EDARBI doses (40 mg/80 mg) materially improve financial performance in generic-dominated markets?
   Higher doses can support revenue per prescription, but do not prevent class-level substitution when payers prefer generics across doses.

5. Can EDARBI maintain a niche presence long-term despite generic ARBs?
   Yes, if payer coverage and patient-specific factors sustain limited branded use, but growth and profitability usually remain constrained by generic dominance.

References

1. FDA Orange Book. Azilsartan medoxomil (EDARBI) listings. US Food and Drug Administration.
2. FDA Labeling: EDARBI (azilsartan medoxomil) Prescribing Information. US Food and Drug Administration / FDA access.

DrugChatter Q&A for EDARBI

When does edarbi go off patent?
Patent protection for edarbi expires this year when will generic be available?
Edarbi generic availability?
Edarbi generic available may 1st 2026?
When does the patent on edarbi run out?