ATACAND HCT Drug Patent Profile

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

Atacand Hct is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in ATACAND HCT 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 Hct

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

Summary for ATACAND HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	46
Patent Applications:	47
Drug Prices:	Drug price information for ATACAND HCT
What excipients (inactive ingredients) are in ATACAND HCT?	ATACAND HCT excipients list
DailyMed Link:	ATACAND HCT at DailyMed

See drug prices for ATACAND HCT

Recent Clinical Trials for ATACAND HCT

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 HCT clinical trials

Pharmacology for ATACAND HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for ATACAND HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	32 mg/25 mg	021093	1	2009-03-06
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	16 mg/12.5 mg and 32 mg/12.5 mg	021093	1	2008-06-25

US Patents and Regulatory Information for ATACAND HCT

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 HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	AB	RX	Yes	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	AB	RX	Yes	No
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	AB	RX	Yes	Yes

Expired US Patents for ATACAND HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,196,444*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,721,263
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,196,444*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,703,110
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	7,538,133*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,721,263
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,196,444*PED

International Patents for ATACAND HCT

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

Country	Patent Number	Title	Estimated Expiration
Germany	69133149
Japan	2514282
European Patent Office	0628313	Combinaison d'un benzimidazole ayant une activité antagoniste de l'angiotensine-II avec manidipine pour le traitement de la hypertension arterielle (Combination of an angiotensin-II antagonising benzimidazole with manidipine for the treatment of hypertension)
Hungary	213266	PROCESS FOR PRODUCING BENZIMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Germany	69123784
Australia	2839192
Austria	372115

Supplementary Protection Certificates for ATACAND HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0459136	8/1998	Austria		PRODUCT NAME: CANDESARTAN CILEXETIL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-22232, 1-22233, 1-22235, 1-22236 19971119; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429
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	SZ 8/1998	Austria
0459136	19875004	Germany		PRODUCT NAME: WIRKSTOFF DES ARZNEIMITTELS BLOPRESS BZW. DES ARZNEIMITTELS ATACAND IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; NAT. REGISTRATION NO/DATE: 41261.00.00 41261.01.00 41261.02.00 41261.03.00 41294.00.00 41294.01.00 41294.02.00 41294.03.00 19971203 FIRST REGISTRATION: GROSSBRITANNIEN 15661/0001 15661/0002 15661/0003 15661/0004 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	C970044	Netherlands		PRODUCT NAME: CANDESARTAN, DESGENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF VAN DE 1-(CYCLOHEXYLOXYCARBONYLOXY) ETHYLESTE R, IN HET BIJZONDER CILEXETILI CANDESARTANAS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 21703 - RVG 21706 19971013; FIRST REGISTRATION: GB PL 15661/0001 - PL 15661/0004 19970429

Market Dynamics and Financial Trajectory of ATACAND HCT

Last updated: July 28, 2025

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Introduction

ATACAND HCT, a fixed-dose combination therapy comprising candesartan cilexetil, hydrochlorothiazide, and amlodipine, addresses hypertension and heart failure management. Since its approval, it has become a component of the therapeutic arsenal globally, driven by an expanding patient population and evolving prescribing patterns. Understanding the intricate market dynamics and financial trajectory of ATACAND HCT is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Market Overview and Demand Drivers

Global Blood Pressure Management Market Growth

The global hypertension market has seen consistent expansion, driven by rising prevalence, aging populations, and increased awareness of cardiovascular health. According to the WHO, an estimated 1.28 billion adults worldwide have high blood pressure, with projections indicating continued growth (WHO, 2021).

Shift Toward Fixed-Dose Combinations (FDCs)

FDCs like ATACAND HCT simplify treatment regimens, improve adherence, and potentially reduce adverse effects. As clinicians aim to optimize compliance, demand for such combination therapies surges, further reinforcing ATACAND HCT’s market position.

Clinical Efficacy and Safety Profile

ATACAND HCT demonstrates favorable efficacy in blood pressure reduction and cardiovascular risk mitigation. Its safety profile is well-characterized, supporting preferred prescribing among cardiologists and general practitioners.

Regulatory Landscape and Approvals

Regulatory access in major markets—US, EU, Japan, and emerging economies—further fuels demand. In the US, the drug’s inclusion in hypertension treatment guidelines elevates its clinical prominence.

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Competitive Landscape

Major Competitors and Market Share

ATACAND HCT competes with other FDCs like Olmesartan/HCTZ, Amlodipine/HCTZ, and combinations from branded and generic manufacturers. Generic competition, especially in mature markets, exerts pricing pressure, impacting revenue streams.

Patent Status and Exclusivity

Candesartan’s patent expiration in key jurisdictions diminished exclusivity, leading to increased generics availability and price erosion post-2014. However, sustained brand recognition and physician familiarity preserve niche market segments.

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Pricing Trends and Reimbursement Factors

Pricing Dynamics

The introduction of generics has led to significant price reductions in developed markets. Variations in pricing strategies—such as value-based pricing and negotiated discounts—shape revenue potential.

Reimbursement and Formularies

Insurance coverage, formulary placements, and prescribing restrictions heavily influence sales. Inclusion in national guidelines and formulary listings enhances market penetration.

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Market Access and Regional Variability

North America

The US captures a substantial share, propelled by high hypertension prevalence and a well-established healthcare infrastructure. The generic wave post-patent expiry facilitated broader accessibility but constrained revenues for the original manufacturer.

Europe

European markets exhibit diverse regulatory environments; countries with rigorous approval processes and price controls pose barriers. Nonetheless, the aging European population sustains demand.

Emerging Markets

Growth potential remains high owing to expanding healthcare coverage, increasing hypertension awareness, and cost-sensitive purchasing. Local manufacturing, partnerships, and generic proliferation accelerate market entry.

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Financial Trajectory Projections

Revenue Trends

Post-patent expiry, revenues from ATACAND HCT faced decline due to generic competition. However, innovations, line extensions, and expanded indications have partially stabilized income streams.

Forecasted Market Share Evolution

Analysts project gradual stabilization with a modest decline in some mature markets, offset by growth opportunities in emerging economies. The shift towards personalized medicine and adherence-enhancing formulations could influence future revenue streams.

Profitability Outlook

Price erosion and intense competition impact margins. Strategic investments in biosimilars, digital health integration, and patient engagement may sustain profitability in the mid to long term.

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Emerging Trends Influencing Market Dynamics

Digital Health and Remote Monitoring

The integration of digital tools to monitor blood pressure and medication adherence presents opportunities to augment ATACAND HCT’s positioning through improved patient outcomes and data-driven management.

Policy and Regulatory Reforms

Price control measures, such as those enacted by governments aiming to reduce healthcare expenditure, influence revenues. Ongoing policy debates on drug pricing emphasize the importance of competitive differentiation.

Novel Therapeutic Developments

Emergence of innovative antihypertensive agents with superior efficacy or safety could influence market share. However, the established safety and efficacy of ATACAND HCT provide a competitive moat.

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Regulatory and Patent Outlook

Patent Landscape

Patent expiries for the active components have paved the way for generics, creating revenue challenges. However, patent protections on formulation patents or new delivery mechanisms could provide temporary exclusivity.

Regulatory Strategies

Companies may pursue new formulations, updated dosage regimens, or supplemental indications to extend market viability within regulatory frameworks.

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Conclusion

The financial trajectory of ATACAND HCT encounters a complex interplay of declining exclusivity, evolving market demands, and competitive pressures. While the generic wave has tempered revenue growth, strategic positioning, portfolio diversification, and technological integration offer avenues for stabilization and future growth—particularly in emerging markets. Stakeholders must remain adaptive to regulatory shifts, technological innovations, and changing prescriber behaviors to capitalize on the drug’s existing momentum.

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Key Takeaways

• The global hypertensive market’s growth, paired with the clinical benefits of combination therapies, sustains demand for ATACAND HCT.
• Patent expiries and generic competition have substantially impacted revenues, necessitating diversification strategies.
• Regional variation in market access, reimbursement policies, and healthcare infrastructure significantly influence market performance.
• Emerging trends like digital health integration and policy reforms offer both challenges and opportunities for future profitability.
• Maintaining market relevance requires continuous innovation, strategic collaborations, and adaptation to evolving regulatory landscapes.

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FAQs

1. How has patent expiration affected ATACAND HCT’s market share?
   Patent expiry led to increased generic competition, resulting in significant price erosion and market share declines in mature markets like the US and Europe.

2. What strategies can enhance ATACAND HCT’s market longevity?
   Developing new formulations, expanding indications, leveraging digital health technologies, and entering emerging markets are key strategies.

3. Are there upcoming regulatory hurdles facing ATACAND HCT?
   Future hurdles include price regulation policies and the approval of competing therapies; however, current pathways remain accessible, especially with indications for new populations.

4. What role do emerging markets play in the drug’s future?
   They represent high growth potential due to increasing hypertension prevalence, expanding healthcare access, and less saturated markets.

5. How does competition from other antihypertensive FDCs impact ATACAND HCT’s profitability?
   Competition influences pricing, market share, and margins, necessitating differentiation and strategic positioning to sustain profitability.

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References

[1] WHO. (2021). Hypertension. World Health Organization.
[2] Market Research Future. (2022). Global Hypertension Drugs Market Analysis.
[3] FDA. (2014). Candesartan Cilexetil: Patent Expiry and Generics Market Impact.
[4] IQVIA. (2022). Global Market Data for Antihypertensive Drugs.
[5] European Medicines Agency. (2021). Approval and Regulatory Trends for Fixed-Dose Combinations.