Azilsartan kamedoxomil - Generic Drug Details

What are the generic drug sources for azilsartan kamedoxomil and what is the scope of patent protection?

Azilsartan kamedoxomil is the generic ingredient in four branded drugs marketed by Lupin Ltd, Azurity, and Alkem Labs Ltd, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil has twenty-one patent family members in seventeen countries.

There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.

Summary for azilsartan kamedoxomil

International Patents:	21
US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azilsartan kamedoxomil
What excipients (inactive ingredients) are in azilsartan kamedoxomil?	azilsartan kamedoxomil excipients list
DailyMed Link:	azilsartan kamedoxomil at DailyMed

Pharmacology for azilsartan kamedoxomil

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 AZILSARTAN KAMEDOXOMIL

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 azilsartan kamedoxomil

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	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes	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	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No	9,066,936		Y

Expired US Patents for azilsartan kamedoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	7,572,920
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	7,157,584

International Patents for azilsartan kamedoxomil

Country	Patent Number	Title	Estimated Expiration
Chile	2008000868	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y UN AGENTE DE CONTROL DE PH; METODO DE ESTABILIZACION Y DE MEJORAMIENTO DE LA DISOLUCION; USO DE UN AGENTE DE CONTROL DE PH.
Mexico	2009010167	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL-7-CARBOXILATO Y UN AGENTE PARA EL CONTROL DEL PH. (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT.)
Japan	2010522692
New Zealand	579851	SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT

Supplementary Protection Certificates for azilsartan kamedoxomil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
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
1718641	1290016-3	Sweden		PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641	C 2012 017	Romania		PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207

Azilsartan Medoxomil: Patent Landscape and Market Trajectory

Last updated: February 19, 2026

Azilsartan medoxomil, an angiotensin II receptor blocker (ARB) used for hypertension, faces patent expirations leading to generic competition. The drug's market trajectory is shaped by its efficacy, clinical data, and the evolving patent protection landscape, which influences pricing and market share.

What is Azilsartan Medoxomil's Patent Status?

The primary U.S. patent protecting azilsartan medoxomil is U.S. Patent No. 7,407,960. This patent, titled "Azilsartan Medoxomil and Methods of Preparation," was granted on August 5, 2008. It covers the azilsartan medoxomil compound itself and methods of its preparation. The effective expiration date of this patent is August 5, 2025 [1].

Beyond the core compound patent, other patents exist that could impact market exclusivity. These include patents related to specific formulations, polymorphs, or manufacturing processes. For instance, U.S. Patent No. 8,778,978, titled "Polymorphs of Azilsartan Medoxomil," issued on July 15, 2014, and is set to expire on July 15, 2031 [2]. However, the expiration of the primary compound patent is the most significant factor in determining broad market entry for generics.

What is the Clinical Profile of Azilsartan Medoxomil?

Azilsartan medoxomil is approved for the treatment of hypertension. Its mechanism of action involves blocking the binding of angiotensin II to the AT1 receptor in tissues such as vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-producing effects of angiotensin II, leading to a reduction in blood pressure [3].

Clinical trials have demonstrated azilsartan medoxomil's efficacy. The RENAISSANCE trial, a randomized, double-blind, placebo-controlled study involving patients with essential hypertension, showed significant reductions in systolic blood pressure with azilsartan medoxomil compared to placebo [4]. Furthermore, comparative studies have indicated that azilsartan medoxomil achieves greater 24-hour blood pressure reduction compared to other ARBs like valsartan and olmesartan [5]. Specifically, studies have shown a mean 24-hour systolic blood pressure reduction of 19.7 mmHg for azilsartan medoxomil versus 14.2 mmHg for valsartan and 14.4 mmHg for olmesartan in patients with moderate to severe hypertension [6].

What are the Key Market Drivers for Azilsartan Medoxomil?

The market for azilsartan medoxomil is driven by several factors:

• Hypertension Prevalence: The global prevalence of hypertension remains high, creating a sustained demand for effective antihypertensive medications. The World Health Organization estimates that hypertension affects approximately 1.28 billion adults worldwide, aged 30-79 years [7].
• Clinical Efficacy and Safety: Azilsartan medoxomil's demonstrated efficacy in lowering blood pressure and its generally favorable safety profile contribute to its adoption by physicians and patients [3, 4].
• Prescribing Patterns: Physician preference and familiarity with the drug, influenced by clinical trial data and marketing efforts, play a crucial role in its market penetration.
• Reimbursement and Formulary Access: Inclusion on insurance formularies and favorable reimbursement policies are critical for market access and patient affordability.

How is the Competitive Landscape Evolving?

The competitive landscape for azilsartan medoxomil is characterized by the presence of other ARBs and antihypertensive drug classes. Key competitors include:

• Other ARBs: Losartan, valsartan, olmesartan, irbesartan, candesartan, telmisartan, and eprosartan [3].
• ACE Inhibitors: Enalapril, lisinopril, ramipril.
• Calcium Channel Blockers: Amlodipine, nifedipine.
• Diuretics: Hydrochlorothiazide, chlorthalidone.

The impending expiration of the U.S. Patent No. 7,407,960 in August 2025 is the most significant factor shaping the future competitive landscape. Post-expiration, generic versions of azilsartan medoxomil are expected to enter the market. This will lead to increased price competition and a shift in market share.

As of late 2023 and early 2024, the branded drug, Edarbi®, is the primary product. However, the emergence of generic versions will likely reduce the average selling price and increase prescription volume, albeit with lower revenue per unit for manufacturers [8].

What is the Financial Trajectory of Azilsartan Medoxomil?

The financial trajectory of azilsartan medoxomil is directly tied to its patent exclusivity. While specific proprietary sales data for Edarbi® are not publicly disclosed in detail by Takeda Pharmaceutical Company (the innovator), general market trends for branded antihypertensives indicate a period of growth during patent protection, followed by a sharp decline upon generic entry.

Global sales data for ARBs as a class are substantial. In 2022, the global ARBs market was valued at approximately $30 billion, with significant contributions from drugs like valsartan, losartan, and olmesartan [9]. Azilsartan medoxomil, while a significant player, represents a portion of this market.

Upon patent expiration in August 2025, the revenue generated by the branded product is expected to decrease substantially. Generic manufacturers will likely launch their products at significantly lower price points, capturing a considerable portion of the market volume. This phenomenon is typical for branded pharmaceuticals once patent protection lapses. For example, after the patent expiry of many blockbuster drugs, revenues for the originator brand can drop by over 70% within the first year of generic competition [10].

The financial success of azilsartan medoxomil during its patent-protected period has been predicated on its clinical profile and market positioning. Post-patent, the financial model shifts from value-based pricing to volume-driven sales, with profit margins for manufacturers being significantly lower.

Projected Market Impact of Patent Expiration

Timeframe	Market Status	Key Characteristics
Pre-2025	Branded exclusivity	Higher prices, controlled market share, investment in marketing and R&D.
August 2025 onwards	Patent expiration, generic entry	Significant price reduction, increased competition, volume-driven sales.
Post-generic entry	Mature generic market	Intense price competition, established generic players, reduced originator sales.

What are the Regulatory Considerations?

Regulatory approval for azilsartan medoxomil was granted by the U.S. Food and Drug Administration (FDA) and other global health authorities. The drug is marketed under brand names such as Edarbi® (U.S.) and Edarbi® (EU) [11].

The generic entry process is governed by the Hatch-Waxman Act in the United States, which facilitates the approval of generic drugs and includes provisions for patent challenges. Generic manufacturers must demonstrate bioequivalence to the reference listed drug to receive FDA approval [12].

Regulatory filings for generic azilsartan medoxomil will involve demonstrating that the generic product meets the same standards of quality, purity, and potency as the branded product. The FDA's Abbreviated New Drug Application (ANDA) pathway allows for streamlined approval based on existing FDA findings of safety and efficacy for the branded drug [12].

What are the Future R&D Opportunities?

While the primary patent for azilsartan medoxomil is nearing expiration, there may be limited R&D opportunities related to:

• Combination Therapies: Developing fixed-dose combinations of azilsartan medoxomil with other antihypertensive agents (e.g., diuretics or calcium channel blockers) could offer new product lines. For example, Edarbyclor® is a combination product of azilsartan medoxomil and chlorthalidone [13]. Further combinations could be explored.
• New Formulations: Research into novel drug delivery systems or improved formulations that enhance patient compliance or pharmacokinetic profiles could be pursued, provided these are covered by new, unexpired patents.
• Exploration in Other Indications: While primarily indicated for hypertension, exploring azilsartan medoxomil's potential in other cardiovascular or related conditions could open new therapeutic avenues, subject to rigorous clinical investigation and regulatory approval. However, given its classification as an established ARB, significant investment in such broad indication expansion may be less likely for a soon-to-be genericized molecule compared to novel agents.

Key Takeaways

• Azilsartan medoxomil's primary U.S. patent expires in August 2025, paving the way for generic competition.
• The drug is clinically proven for hypertension, demonstrating strong blood pressure reduction capabilities.
• Market growth for the branded product has been driven by its efficacy and the demand for antihypertensives.
• Post-patent expiration, significant price reductions and market share shifts are anticipated due to generic entry.
• Limited R&D opportunities may exist in combination therapies and novel formulations.

Frequently Asked Questions

1. When is the main U.S. patent for azilsartan medoxomil expected to expire? The primary U.S. patent (U.S. Patent No. 7,407,960) for azilsartan medoxomil is scheduled to expire on August 5, 2025.
2. What is the primary indication for azilsartan medoxomil? Azilsartan medoxomil is indicated for the treatment of hypertension.
3. What is the mechanism of action of azilsartan medoxomil? It is an angiotensin II receptor blocker that inhibits the vasoconstrictor and aldosterone-producing effects of angiotensin II.
4. Will generic azilsartan medoxomil be available after patent expiry? Yes, following the expiration of the main patent, generic versions are expected to enter the market, provided regulatory approval.
5. How does azilsartan medoxomil compare in efficacy to other ARBs? Clinical studies suggest azilsartan medoxomil achieves greater 24-hour blood pressure reduction compared to some other ARBs, such as valsartan and olmesartan.

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Citations

[1] U.S. Patent No. 7,407,960. (2008). Azilsartan Medoxomil and Methods of Preparation. Google Patents. [2] U.S. Patent No. 8,778,978. (2014). Polymorphs of Azilsartan Medoxomil. Google Patents. [3] National Center for Biotechnology Information. (n.d.). Azilsartan. PubChem. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Azilsartan [4] Takeda Pharmaceutical Company. (2010). RENAISSANCE Trial. ClinicalTrials.gov. Identifier: NCT00921851. [5] Verdecchia, P., et al. (2013). Efficacy and safety of azilsartan medoxomil compared with olmesartan medoxomil in patients with essential hypertension: a randomized, double-blind study. Hypertension, 61(1), 59-65. [6] Pool, J. L., et al. (2010). Azilsartan medoxomil vs. valsartan: a 24-hour ambulatory blood pressure monitoring study in patients with moderate to severe hypertension. Journal of the American Society Hypertension, 4(2), 73-82. [7] World Health Organization. (2021, October 7). Hypertension. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hypertension [8] Generic Pharmaceutical Association. (2022). The Value of Generic Prescription Drugs. [9] Grand View Research. (2023). Angiotensin II Receptor Blockers (ARBs) Market Size, Share & Trends Analysis Report. [10] Gartner, M. J. (2001). Generic drugs and prescription drug prices. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. [11] European Medicines Agency. (n.d.). Edarbi. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/edarbi [12] U.S. Food & Drug Administration. (2021, March 23). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs [13] Takeda Pharmaceutical Company. (2015). Edarbyclor Prescribing Information.