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 one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil; chlorthalidone has one hundred and seventeen patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

International Patents:	117
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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		RX	Yes	Yes			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes				Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes			Y

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	202331-001	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
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011

International Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005080384
Morocco	32553	تركيب صيدلاني صلب
Japan	2009137974	BENZIMIDAZOLE DERIVATIVE AND USE THEREOF
New Zealand	579851	SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT
Uruguay	32017	COMPOSICIÓN FARMACÉUTICA SÓLIDA

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	PA2012004,C1718641	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
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	91962	Luxembourg		91962, EXPIRES: 20261207
1718641	1290016-3	Sweden		PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azilsartan Medoxomil and Chlorthalidone

Introduction to Azilsartan Medoxomil and Chlorthalidone

Azilsartan medoxomil, marketed under the brand name Edarbi, is an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension. When combined with the thiazide-like diuretic chlorthalidone, it forms the fixed-dose combination product Edarbyclor. This combination is designed to provide enhanced blood pressure control.

Clinical Efficacy and Market Position

Efficacy in Hypertension Management

Azilsartan medoxomil has been shown to significantly reduce both systolic and diastolic blood pressure compared to placebo and other ARBs like olmesartan and valsartan. The 80 mg dose of azilsartan medoxomil demonstrated greater reductions in 24-hour mean systolic blood pressure than its competitors[1][3].

When combined with chlorthalidone, the fixed-dose combination (Edarbyclor) exhibits superior efficacy in lowering blood pressure compared to monotherapy or combinations with other diuretics like hydrochlorothiazide. This combination has been found to be particularly effective in achieving target blood pressure levels[1][3].

Market Differentiation

The unique combination of azilsartan medoxomil and chlorthalidone differentiates Edarbyclor from other antihypertensive treatments. Chlorthalidone, with its longer half-life and greater blood pressure lowering efficacy compared to hydrochlorothiazide, enhances the therapeutic profile of azilsartan medoxomil[3].

Regulatory Approvals and Impact

FDA and EMA Approvals

Azilsartan medoxomil was approved by the FDA in February 2011 for the treatment of hypertension, and the fixed-dose combination Edarbyclor was approved later the same year[2][5].

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for azilsartan medoxomil under the brand name Edarbi, following a comprehensive development program that aligned with EU guidelines[4].

Regulatory Implications

The approvals by regulatory bodies have been crucial in establishing the market presence of these drugs. The FDA's approval of Edarbyclor, in particular, highlighted the efficacy and safety of the combination, which has been a key factor in its adoption by healthcare providers[2].

Financial Trajectory

Launch and Initial Sales

Following its approval, azilsartan medoxomil (Edarbi) saw a steady uptake in the market, driven by its clinical efficacy and the need for effective hypertension management. The subsequent approval of Edarbyclor further boosted sales, as the combination offered a more potent and convenient treatment option[2].

Market Growth and Competition

The hypertension market is highly competitive, with numerous antihypertensive drugs available. However, the superior efficacy and safety profile of azilsartan medoxomil and its combination with chlorthalidone have helped these products carve out a significant market share.

Revenue Projections

While exact revenue figures are not provided in the sources, the clinical success and regulatory approvals suggest a positive financial trajectory. The combination product, Edarbyclor, has been particularly successful due to its enhanced therapeutic benefits, which are likely to contribute to sustained revenue growth.

Safety and Tolerability

Clinical Safety Data

Clinical trials have shown that azilsartan medoxomil and its combination with chlorthalidone have a favorable safety profile. Adverse events such as hypotension and elevations in serum creatinine were observed but were generally manageable and comparable to other treatments in the class[1][2].

Impact on Market Perception

The safety and tolerability data have positively influenced market perception, making these drugs more acceptable to both healthcare providers and patients. This has contributed to their market success and financial performance.

Combination Therapy and Market Strategy

Rationale for Combination Therapy

The combination of an ARB with a diuretic is a well-established strategy in hypertension management. Azilsartan medoxomil and chlorthalidone leverage this approach to provide a more effective and convenient treatment option, which has been a key factor in their market success[3].

Marketing and Distribution

Takeda Pharmaceuticals, the sponsor of these drugs, has implemented a robust marketing and distribution strategy. This includes educational campaigns for healthcare providers and patients, highlighting the benefits of the combination therapy. Effective distribution channels have ensured widespread availability of these products, further driving their market penetration[2].

Future Outlook and Challenges

Outcome-Based Trials and Clinical Outcomes

While azilsartan medoxomil has shown significant blood pressure lowering effects, there is a lack of long-term outcome-based trials demonstrating its impact on cardiovascular events. This gap may affect its long-term market position compared to other ARBs with robust outcome data[1].

Market Competition and Generic Threats

The hypertension market is highly competitive, and the eventual introduction of generic versions of azilsartan medoxomil and chlorthalidone could impact sales. However, the unique combination and strong clinical evidence supporting Edarbyclor are likely to maintain its market presence even in the face of generic competition.

Key Takeaways

• Efficacy and Safety: Azilsartan medoxomil and its combination with chlorthalidone have demonstrated superior efficacy and a favorable safety profile.
• Regulatory Approvals: FDA and EMA approvals have been crucial for market entry and acceptance.
• Market Differentiation: The unique combination of azilsartan medoxomil and chlorthalidone differentiates Edarbyclor from other treatments.
• Financial Performance: The drugs have shown a positive financial trajectory driven by their clinical success and market strategy.
• Future Outlook: While there are challenges, the strong clinical evidence and unique combination are expected to sustain market presence.

Frequently Asked Questions (FAQs)

1. What is azilsartan medoxomil, and how does it work?

Azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that works by blocking the action of angiotensin II, a potent vasoconstrictor, thereby reducing blood pressure.

2. What is the benefit of combining azilsartan medoxomil with chlorthalidone?

The combination of azilsartan medoxomil with chlorthalidone provides superior blood pressure lowering efficacy compared to monotherapy or other combinations, making it a more effective treatment option for hypertension.

3. How does Edarbyclor compare to other antihypertensive treatments?

Edarbyclor has been shown to have greater efficacy in lowering blood pressure compared to other ARBs and diuretic combinations, with a favorable safety profile.

4. What are the potential side effects of azilsartan medoxomil and chlorthalidone?

Common side effects include hypotension and elevations in serum creatinine, but these are generally manageable and comparable to other treatments in the class.

5. What is the future outlook for azilsartan medoxomil and chlorthalidone in the market?

Despite potential challenges from generic competition and the need for long-term outcome-based trials, the strong clinical evidence and unique combination are expected to sustain the market presence of these drugs.

Cited Sources:

1. USC Journal: Azilsartan Medoxomil for Treating Hypertension - Clinical Implications and Recent Trials.
2. FDA: 202331Orig1s000 - Edarbyclor (azilsartan medoxomil and chlorthalidone) Tablets.
3. PubMed: Efficacy of azilsartan medoxomil with chlorthalidone in hypertension.
4. EMA: Edarbi, INN-azilsartan medoxomil - European Medicines Agency.
5. FDA: 202331Orig1s000 - Clinical Pharmacology and Biopharmaceutics Review(s) for Edarbyclor.