ATACAND Drug Patent Profile

Which patents cover Atacand, and when can generic versions of Atacand launch?

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 PHARMOBEDIENT on December 4^th, 2012.

Summary for ATACAND

US Patents:	0
Applicants:	1
NDAs:	2

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

International Patents for ATACAND

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0720982
Israel	97882	N-aralkylbenzimidazole derivatives their production and pharmaceutical compositions containing them
Brazil	1100710

Supplementary Protection Certificates for ATACAND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

ATACAND Market Analysis and Financial Projection

Last updated: February 3, 2026

What Are the Investment Fundamentals and Scenario for ATACAND?

ATACAND (candesartan cilexitil) is an angiotensin II receptor blocker (ARB) manufactured by AstraZeneca. It is prescribed primarily for hypertension and heart failure. The drug's stability in the cardiovascular market, patent status, and competitive landscape influence its investment potential.

Market Overview

The global antihypertensive drugs market was valued at approximately USD 24 billion in 2022 and is projected to grow at a CAGR of 3.9% through 2028. ARBs like ATACAND account for around 20% of this market. Leading competitors include losartan-based products, valsartan, and other ARBs, with a trend toward fixed-dose combinations and generic versions.

Patent and Regulatory Status

• Patent Expiry: The original patent covering ATACAND expired in key markets by 2017, with generic versions available since then.
• Regulatory Approvals: Approved for hypertension and heart failure in multiple jurisdictions. No recent extensions or new indications approved.
• Pricing & Reimbursement: Generic entry has suppressed prices, limiting profit margins.

Sales and Revenue Trends

AstraZeneca's cardiovascular franchise, including ATACAND, generated approximately USD 1.1 billion globally in 2022, with ATACAND accounting for an estimated USD 250 million (23%). Sales have declined 10% annually since 2018 due to generic competition.

Patent Litigation and Market Entry

• Legal Challenges: Patent litigations in the U.S. and Europe failed to prevent generic entry, leading to market erosion.
• Market Dynamics: The presence of multiple generics reduces prices and profits. Future market share depends on brand loyalty and physician prescribing habits.

Key Financial Indicators

Indicator	2022	Notes
Revenue	USD 250 million	Declined from USD 350 million (2018)
Market Share	15-20%	Within ARB segment; declining trend
R&D Investment	Approx. USD 150 million	Focused on next-generation ARBs
Patent Status	Expired (2017 in major markets)	Generics dominate post-expiry

Investment Scenario Analysis

Base Scenario

• Market Conditions: Continued generic erosion leads to flat or declining revenues.
• Profit Margins: Shrink due to price competition.
• Valuation Impact: Expected to decrease in the absence of new indications or formulation improvements.

Upside Scenario

• New Use Cases: Successful development of combination therapies or new indications.
• Market Expansion: Entry into emerging markets with less generic penetration.
• Regulatory Incentives: Favorable policy changes or orphan drug status could restore profit margins.

Downside Scenario

• Competitive Pressure: Accelerated generic market penetration and price declines.
• Regulatory Barriers: Lost exclusivity without alternatives.
• Market Shrinkage: Diminished physician preference for brand prescriptions.

Competitive Landscape

Drug	Manufacturer	Year of Patent Expiry	Market Share 2022	Notes
Losartan	Merck	2010 (U.S.)	25%	First ARB, now generic-driven
Valsartan	Novartis	2012	15%	Facing recalls and competition
Candesartan (ATACAND)	AstraZeneca	2017	15-20%	Declining post-generic entry

Strategic Considerations

• The core revenue stream from ATACAND faces erosion due to patent expiration and generic competition.
• Investment prospects depend on pipeline development, such as next-generation ARBs.
• Partnerships or licensing agreements may create value, especially if new formulations or indications are approved.
• Market share in emerging economies remains underpenetrated but offers growth avenues.

Key Takeaways

• ATACAND has experienced revenue decline following patent expiration and generic entry.
• The drug remains part of a competitive ARB segment with a declining profitability profile.
• Future value hinges on pipeline success, market expansion, and regulatory strategies.
• Near-term downside risk exists due to lucrative generics reducing drug prices.
• Long-term upside potential depends on innovation and market diversification.

FAQs

1. What is the current patent status of ATACAND?
Patent expiration occurred in major markets in 2017, allowing generics to enter and erode branded sales.

2. Can ATACAND regain market share through new indications?
No recent approvals of new indications exist; future development could potentially open new revenue streams.

3. How vulnerable is ATACAND to generic competition?
Highly vulnerable; generics hold the majority of prescriptions and significantly reduce profit margins.

4. Are there any ongoing pipeline projects for ATACAND?
AstraZeneca is investing in next-generation ARBs but has no announced pipeline specifically targeting ATACAND.

5. Is the market for antihypertensive drugs growth again?
The market continues to grow modestly; however, branded ARBs like ATACAND face declining revenues due to generics.

References

[1] MarketsandMarkets. "Antihypertensive Drugs Market." 2022.
[2] AstraZeneca Annual Report 2022.
[3] IQVIA. "Global Market Share Data," 2022.
[4] U.S. Patent and Trademark Office (USPTO). Patent expiry information.
[5] European Medicines Agency (EMA). Regulatory approval and market data.