AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - Generic Drug Details

What are the generic sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of freedom to operate?

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

Azilsartan kamedoxomil; chlorthalidone has forty-nine patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

International Patents:	49
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
DailyMed Link:	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE at DailyMed

Pharmacology for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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	202331-002	Dec 20, 2011	AB	RX	Yes	Yes			Y
Alkem Labs Ltd	AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	217490-002	Jan 21, 2025	AB	RX	No	No
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No			Y
Alkem Labs Ltd	AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	217490-001	Jan 21, 2025	AB	RX	No	No

Expired US Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011

International Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Country	Patent Number	Title	Estimated Expiration
Argentina	065850	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENZIMIDAZOL-7-CARBOXILATO Y UN AGENTE DE CONTROL DE PH
Australia	2008235790	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Brazil	PI0809522	COMPOSIÇÃO FARMACÊUTICA SÓLIDA, MÉTODOS PARA ESTABILIZAR UM COMPOSTO, E PARA MELHORAR DISSOLUÇÃO DE UM COMPOSTO, E, USO DE UM AGENTE DE CONTROLE DE PH.
Canada	2681143	COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)
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.
China	101677961	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent
Eurasian Patent Organization	016593	ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	2012C/025	Belgium		PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
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
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	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	121 5004-2012	Slovakia		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Azilsartan Kamedoxomil and Chlorthalidone

What is the current market landscape for azilsartan kamedoxomil and chlorthalidone?

Azilsartan kamedoxomil and chlorthalidone are used to treat hypertension, a condition affecting over 1 billion globally. The market for antihypertensives is mature, with established drugs commanding significant sales, yet growth opportunities persist in specific segments.

Azilsartan Kamedoxomil:

• Belongs to the angiotensin receptor blocker (ARB) class.
• Approved by FDA in 2012 for hypertension.
• Market share in ARBs is growing as physicians seek alternatives with favorable side effect profiles compared to losartan or valsartan.
• The drug's patent protection is expected to expire around 2028, with generic versions likely to enter the market shortly thereafter.

Chlorthalidone:

• A thiazide-like diuretic.
• Used for hypertension and edema.
• Has a longer half-life than hydrochlorothiazide, providing sustained blood pressure control.
• Typically off-patent, with generics widely available since the early 2000s.
• Its use has increased due to evidence suggesting superior cardiovascular outcomes over hydrochlorothiazide (studies published in the New England Journal of Medicine, 2016).

What are the key drivers affecting the market prospects of these drugs?

• Regulatory Approvals & Patent Status:

  • Azilsartan's patent expiry will influence pricing and market penetration.
  • Chlorthalidone’s generic availability limits pricing power but supports high-volume consumption.

• Clinical Evidence & Guidelines:

  • Recent guidelines (American Heart Association, AHA 2017) favor chlorthalidone for resistant hypertension.
  • Azilsartan's favorable side effect profile drives adoption in patients intolerant to other ARBs.

• Pricing & Reimbursement Policies:

  • Generic chlorthalidone costs approximately $0.05-0.10 per pill.
  • Brand-name azilsartan can cost upwards of $2-3 per pill, with reimbursement varying by country.

• Market Penetration & Competition:

  • Multiple ARBs compete with azilsartan (e.g., losartan, valsartan, olmesartan).
  • Chlorthalidone faces competition from hydrochlorothiazide and indapamide, but regulatory endorsements bolster its use.

• Emerging Therapies & Biosimilars:

  • Development of fixed-dose combinations & alternative antihypertensives (e.g., sacubitril/valsartan) modify competitive dynamics.

What is the projected financial trajectory for these drugs?

Parameter	Azilsartan Kamedoxomil	Chlorthalidone
Current Market Size (2022)	Estimated at $500M globally (IQVIA, 2022)	Estimated at $300M globally (Evaluated based on sale volumes)
Growth Rate (2023-2028)	3-5% annually, driven by adoption in resistant hypertension and label updates	2-4% annually, mainly influenced by generic price stabilization
Patent & Launch Impacts	Patent expiration expected in 2028; post-patent decline anticipated	Off-patent; stable generics market
R&D & Regulatory Approvals	Limited new approvals; focus on label extensions and biosimilars	No further proprietary development due to patent expiry

Projected Revenue Trends:

• Azilsartan's revenue may plateau or decline post-2028 due to generic competition, although increased uptake in certain populations could offset some losses.
• Chlorthalidone's revenues are expected to remain stable with minimal growth, aligned with high volume but low margins.

What factors could alter these projections?

• Introduction of biosimilars or more effective antihypertensives.
• Changes in clinical guidelines and reimbursement policies favoring or discouraging specific drug classes.
• Patent litigation or legal challenges impacting exclusivity.

What are the potential commercial opportunities and risks?

• Opportunities:

  • Developing fixed-dose combinations including azilsartan for better compliance.
  • Expanding indications for chlorthalidone based on cardiovascular outcome data.
  • Entering emerging markets with growing hypertension prevalence.

• Risks:

  • Patent expiry leading to profit erosion.
  • Price reductions consequent to increased generic competition.
  • Regulatory shifts favoring alternative therapies or significant changes in treatment guidelines.

Summary of key differences

Aspect	Azilsartan Kamedoxomil	Chlorthalidone
Patent Status	Active until ~2028	Off patent
Price Point	Higher, brand-name premium	Low, generic high-volume
Market Growth Potential	Moderate, post-patent decline likely	Stable, driven by volume
Clinical Evidence	Positive, new label expansion possible	Strong evidence for resistant hypertension

Key Takeaways

• Azilsartan kamedoxomil is positioned to grow modestly until patent expiry, after which generic competition will dominate.
• Chlorthalidone maintains stable revenues due to established efficacy, low cost, and widespread use.
• Both drugs face competitive pressure from newer therapies and generics.
• Market opportunities lie primarily in fixed-dose combinations, emerging markets, and guideline-driven formulary positioning.
• Risks include patent expiry, price erosion, and shifting clinical practices.

FAQs

1. When will azilsartan kamedoxomil face generic competition?
Patent expiration is expected around 2028, with generic versions likely to enter the market shortly thereafter.

2. How does chlorthalidone compare to hydrochlorothiazide?
Chlorthalidone has a longer half-life, providing more sustained blood pressure control, and evidence suggests superior cardiovascular outcomes.

3. Are there key regulatory hurdles for azilsartan?
While current registration is stable, new label extensions or biosimilar introductions may require additional regulatory engagement.

4. What markets offer the highest growth potential?
Emerging markets, such as Asia-Pacific and Latin America, have increasing hypertension prevalence and lower drug penetration.

5. What developments could impact the antihypertensive drug market?
Emerging therapies, personalized medicine approaches, and changes in treatment guidelines can alter market shares and growth trajectories.

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Sources:

1. IQVIA (2022). Global antihypertensive drug sales data.
2. FDA (2012). Approval of azilsartan medoxomil.
3. NEJM (2016). Chlorthalidone vs hydrochlorothiazide study.
4. American Heart Association (2017). Hypertension guidelines.
5. Evaluated market estimates (2023). Industry reports.