ATACAND Drug Patent Profile

When do Atacand patents expire, and what generic alternatives are available?

Atacand is a drug marketed by Ani Pharms and is included in two NDAs.

The generic ingredient in ATACAND is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atacand

A generic version of ATACAND was approved as candesartan cilexetil; hydrochlorothiazide by MYLAN on December 4^th, 2012.

Summary for ATACAND

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	46
Patent Applications:	4,388
Drug Prices:	Drug price information for ATACAND
What excipients (inactive ingredients) are in ATACAND?	ATACAND excipients list
DailyMed Link:	ATACAND at DailyMed

See drug prices for ATACAND

Recent Clinical Trials for ATACAND

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Early Phase 1
BioHealthonomics Inc.	Phase 2
AgoneX Biopharmaceuticals, Inc.	Phase 2

See all ATACAND clinical trials

Pharmacology for ATACAND

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Paragraph IV (Patent) Challenges for ATACAND

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND	Tablets	candesartan cilexetil	4 mg, 8 mg, 16 mg and 32 mg	020838	1	2006-12-22

US Patents and Regulatory Information for ATACAND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	AB	RX	Yes	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	AB	RX	Yes	Yes
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998	AB	RX	Yes	Yes

Expired US Patents for ATACAND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-004	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998

International Patents for ATACAND

See the table below for patents covering ATACAND around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	970195
Norway	302752
Taiwan	284688

Supplementary Protection Certificates for ATACAND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0459136	SPC/GB97/018	United Kingdom		PRODUCT NAME: CANDESARTAN CILEXETIL OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK PL0017/0383 19970429; UK PL0017/0384 19970429; UK PL0017/0385 19970429; UK PL0017/0391 19970429; UK PL15561/0003 19970429; UK PL15661/0001 19970429; UK PL15661/0002 19970429; UK PL15661/0004 19970429
0459136	98C0016	Belgium		PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429
0459136	SZ 8/1998	Austria

Market Dynamics and Financial Trajectory for ATACAND (Candesartan Cilexetil)

Last updated: July 29, 2025

Introduction

ATACAND (candesartan cilexetil), developed by AstraZeneca, is a prominent angiotensin II receptor blocker (ARB) primarily prescribed for hypertension and heart failure management. Since its market introduction, ATACAND has maintained a significant position within the ARB segment, driven by its efficacy, safety profile, and expanding indications. This article delves into the evolving market dynamics, competitive landscape, regulatory influences, and projected financial trajectory of ATACAND.

Market Overview

Global Market Size and Growth Trends

The global antihypertensive drugs market is projected to reach USD 39.5 billion by 2026, expanding at a compound annual growth rate (CAGR) of approximately 4% from 2021 to 2026 [1]. Within this space, ARBs constitute a substantial share, driven by their improved tolerability over ACE inhibitors and favorable cardiovascular outcomes.

ATACAND, as a leading ARB, benefits from this overarching growth, especially in developed markets like the U.S. and Europe, where the treatment guidelines increasingly favor ARBs over other antihypertensive classes due to fewer side effects and comparable efficacy.

Key Market Drivers

• Rising Prevalence of Hypertension and Heart Failure: Globally, over 1 billion individuals are hypertensive, with numbers expected to escalate in emerging economies [2], thereby amplifying demand for ARB therapeutics.
• Shift Toward Favorable Safety Profiles: ARBs are increasingly preferred over ACE inhibitors, especially among patients experiencing cough or angioedema, bolstering ATACAND's market share.
• Label Expansion and Additional Indications: Clinical evidence supports ATACAND’s use in heart failure with reduced ejection fraction (HFrEF), expanding its application scope.
• Introduction of Generics: Patent expiry and subsequent generic competition are influencing pricing and market penetration.

Competitive Landscape

Key Competitors

ATACAND's main rivals include other ARBs like LOSARTAN, VALSARTAN, OLMESARTAN, and IRBESARTAN. Generic versions of Losartan and Valsartan have exerted significant price pressures, prompting AstraZeneca to differentiate ATACAND through clinical positioning and brand loyalty.

Market Position

Despite intensifying generic competition, ATACAND retains a premium positioning owing to:

• Proven efficacy in hypertension and heart failure.
• Favorable safety profile.
• Established clinician familiarity.

However, the competitive landscape remains highly price-sensitive, increasingly driven by generic availability and formulary decisions.

Regulatory and Reimbursement Dynamics

Regulatory Environment

Regulatory agencies such as the U.S. FDA and EMA continually update guidelines affecting antihypertensive therapies. Additionally, a focus on cardiovascular outcome trials influences drug approvals and labeling expansions. For ATACAND, ongoing research enhances its credibility for extended indications.

Reimbursement Policies

Reimbursement strategies in major markets impact sales volume. In the U.S., formulary placements favor cost-effective options, leading AstraZeneca to strategize on market access and payer negotiations to sustain profitability.

Pharmaceutical Financial Trajectory

Sales Performance Historically

ATACAND's sales peaked in the early 2010s but have experienced gradual flattening due to patent expiry of some formulations and increasing generics in certain markets. Nonetheless, sales persist robustly, owing to:

• Continued prescribing in resistant hypertension.
• Use in heart failure management.
• International growth, especially in Asia-Pacific regions.

Patent and Lifecycle Management

The patent for ATACAND's core molecule expired in the U.S. in 2019, with generic versions entering the market, impacting revenue streams. To counteract this, AstraZeneca has focused on:

• Developing new formulations and combination therapies.
• Expanding indications based on clinical trials.
• Pursuing strategic licensing agreements.

Projected Revenue and Market Share Trends

In the next five years, the following trends are anticipated:

• Moderate Revenue Decline in Mature Markets: Due to generics and intense price competition.
• Emerging Market Growth: Rapid urbanization and increasing hypertension prevalence in Asia bolster sales opportunities, especially with localized approval and supply chain optimization.
• Innovation and Label Expansion: New clinical data could revive interest, supporting premium pricing in select segments.

Industry analysts project that, while total ATACAND sales may decline marginally in developed markets, global revenues could stabilize or even slightly grow driven by emerging markets and new indications [3].

Strategic Opportunities

AstraZeneca's strategic focus includes:

• Developing fixed-dose combination (FDC) formulations, such as ATACAND-HCTZ, which can improve adherence and drive sales.
• Exploring cardiovascular outcome trials to solidify ATACAND's position in treatment guidelines.
• Negotiating with payers for favorable formulary placements in core markets.

Market Challenges

Major challenges confronting ATACAND’s financial trajectory include:

• Price Pressure from Generics: Reduced unit prices diminish profit margins.
• Competition from Newer Therapies: The advent of drugs like SGLT2 inhibitors for heart failure and combination therapies influence prescribing habits.
• Regulatory Hurdles: Stringent approval pathways for new indications may delay label expansion efforts.
• Global Economic Factors: Rising healthcare costs and reimbursement constraints limit pricing flexibility.

Conclusion

ATACAND maintains a vital role within the antihypertensive and heart failure markets, underpinned by its established efficacy and safety. While patent expiries and competitive pressures challenge its revenue streams, strategic innovation, geographic expansion, and clinical differentiation could underpin its sustained financial trajectory. The evolving landscape suggests a need for proactive lifecycle management to optimize market share and profitability.

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Key Takeaways

• The global antihypertensive market's growth, especially in emerging markets, offers continued revenue opportunities for ATACAND.
• Patent expiries have introduced significant generic competition, necessitating strategic differentiation and innovation.
• Expanding indications and combination therapies can rejuvenate sales and reinforce ATACAND's market position.
• Navigating reimbursement landscape and formulary decisions is critical for revenue sustainability.
• Strategic investments in clinical research and geographic expansion are essential to offset revenue decline from mature markets.

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FAQs

Q1: How has the patent expiry affected ATACAND’s sales?
A: Patent expiry in key markets like the U.S. led to generic entry, reducing prices and sales volume, impacting AstraZeneca’s revenue from ATACAND.

Q2: What strategies are AstraZeneca implementing to sustain ATACAND’s market position?
A: The company focuses on developing combination formulations, expanding indications through clinical trials, and targeting emerging markets for growth.

Q3: How does the competitive landscape influence ATACAND’s pricing?
A: Increased generic competition exerts downward pressure on prices, making cost-effective positioning and differentiations essential for maintaining profitability.

Q4: Are there new indications for ATACAND in clinical development?
A: Yes, ongoing trials investigate ATACAND's role in heart failure and other cardiovascular conditions, potentially leading to label expansions.

Q5: What is the outlook for ATACAND's revenue over the next five years?
A: While mature markets may experience modest declines due to generics, emerging markets and potential new indications could sustain or slightly increase revenues, provided strategic initiatives succeed.

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References

[1] MarketWatch. "Antihypertensive Drugs Market Size & Industry Trends." 2022.
[2] WHO. "Global Status Report on Noncommunicable Diseases." 2019.
[3] Pharma Intelligence Analysis. "Cardiovascular Market Forecast." 2023.