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:	5
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	46
Patent Applications:	3,988
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
AgoneX Biopharmaceuticals, Inc.	Phase 2
BioHealthonomics 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
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	AB	RX	Yes	No
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	AB	RX	Yes	No

Expired US Patents for ATACAND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998

International Patents for ATACAND

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

Country	Patent Number	Title	Estimated Expiration
Canada	2040955	DERIVES DU BENZIMIDAZOLE, LEUR PRODUCTION ET LEUR UTILITE (BENZIMIDAZOLE DERIVATIVES, THEIR PRODUCTION AND USE)
Germany	69221831
Finland	911936
Netherlands	970044
Israel	97882	N-aralkylbenzimidazole derivatives their production and pharmaceutical compositions containing them

Supplementary Protection Certificates for ATACAND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0459136	98C0016	Belgium		PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 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

ATACAND Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atacand (Candesartan Cilexetil)

Introduction

Atacand, known generically as candesartan cilexetil, is a prescription medication used primarily for the treatment of hypertension and heart failure. It belongs to the class of angiotensin II receptor blockers (ARBs). Here, we will delve into the market dynamics and financial trajectory of Atacand, highlighting its current market size, growth prospects, and significant events that have shaped its commercial landscape.

Global Market Size and Growth Prospects

As of 2024, the global candesartan cilexetil market size is estimated to be USD 584.2 million. This market is projected to expand at a compound annual growth rate (CAGR) of 4.6% from 2024 to 2031[1].

Regional Market Breakdown

The market for Atacand is distributed across various regions, each with its own growth trajectory:

• North America: This region holds the largest share of the global market, with a market size of USD 233.68 million in 2024. It is expected to grow at a CAGR of 2.8% from 2024 to 2031. The United States is the dominant market within North America, with a market size of USD 184.37 million in 2024 and a CAGR of 2.6% during the forecast period[1].
• Europe: Europe accounts for more than 30% of the global revenue, with a market size of USD 175.26 million in 2024. The European market is expected to grow at a CAGR of 3.1% from 2024 to 2031[1].
• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 134.37 million in 2024. The Asia Pacific market is anticipated to grow at a CAGR of 6.6% from 2024 to 2031, driven by countries like China and Japan[1].
• Latin America and Middle East & Africa: These regions also contribute to the global market, with Latin America holding around 5% of the global revenue and the Middle East & Africa holding about 2%. These regions are expected to grow at CAGRs of 4.0% and 4.3%, respectively, from 2024 to 2031[1].

Divestment and Commercial Rights

A significant event in the commercial history of Atacand is the divestment of its commercial rights by AstraZeneca to Cheplapharm Arzneimittel GmbH. In 2018, AstraZeneca agreed to sell the commercial rights for Atacand and Atacand Plus in Europe to Cheplapharm. This agreement included an upfront payment of $200 million, a time-bound payment of $10 million, and sales-contingent milestones[3].

By 2021, this divestment had expanded to over 70 countries, with AstraZeneca receiving a payment of $250 million from Cheplapharm. Additional non-contingent payments of $150 million were also received by AstraZeneca in the first half of 2021[5].

Financial Considerations

The divestment of Atacand's commercial rights has had a notable impact on AstraZeneca's financials. Here are some key financial considerations:

• Revenue from Atacand: In 2017, global product sales for Atacand and Atacand Plus were $300 million, with $86 million coming from Europe alone[3].
• Payments from Divestment: The total payments received by AstraZeneca from Cheplapharm, including upfront, time-bound, and non-contingent payments, amount to significant figures, contributing to AstraZeneca's financial performance[3][5].

Market Drivers and Challenges

Several factors drive the market for Atacand:

• Increasing Prevalence of Hypertension: The growing prevalence of hypertension and heart failure globally drives the demand for antihypertensive medications like Atacand.
• Aging Population: An aging population increases the incidence of cardiovascular diseases, further boosting the demand for Atacand.
• Competition: The antihypertensive drugs market is highly competitive, with various classes of drugs and fixed-dose combinations available. This competition can impact the market share of Atacand[4].

Future Outlook

The future outlook for Atacand is positive, driven by the growing need for effective antihypertensive medications. Here are some key points:

• Growth in Emerging Markets: The Asia Pacific and Latin American regions are expected to show significant growth, driven by increasing healthcare spending and a growing awareness of cardiovascular diseases.
• Continued Commercial Presence: Despite the divestment, AstraZeneca continues to manufacture and supply Atacand under supply agreements, ensuring its continued availability in the market[3].

Key Takeaways

• The global candesartan cilexetil market is valued at USD 584.2 million in 2024 and is expected to grow at a CAGR of 4.6% from 2024 to 2031.
• North America, Europe, and Asia Pacific are the major regions driving the market.
• The divestment of commercial rights to Cheplapharm has significantly impacted AstraZeneca's financials.
• Increasing prevalence of hypertension and an aging population are key drivers of the market.
• Emerging markets are expected to contribute significantly to the future growth of Atacand.

FAQs

1. What is the current global market size for candesartan cilexetil?

   • The global candesartan cilexetil market size is estimated to be USD 584.2 million in 2024[1].

2. What is the projected CAGR for the global candesartan cilexetil market from 2024 to 2031?

   • The global candesartan cilexetil market is expected to grow at a CAGR of 4.6% from 2024 to 2031[1].

3. Which region holds the largest share of the global candesartan cilexetil market?

   • North America holds the largest share of the global market, with a market size of USD 233.68 million in 2024[1].

4. Who acquired the commercial rights for Atacand from AstraZeneca?

   • Cheplapharm Arzneimittel GmbH acquired the commercial rights for Atacand from AstraZeneca[3][5].

5. What were the financial considerations for AstraZeneca in the divestment of Atacand?

   • AstraZeneca received an upfront payment of $200 million, a time-bound payment of $10 million, and additional non-contingent payments totaling $150 million in the first half of 2021[3][5].

Sources

1. Cognitive Market Research - Candesartan Cilexetil Market Report
2. AstraZeneca - Full year and Q4 2021 results - AstraZeneca
3. AstraZeneca - Atacand to be divested to Cheplapharm in Europe
4. iHealthcareAnalyst - Antihypertensive Drugs Market and Forecast 2024-2031
5. AstraZeneca - Atacand divestment to Cheplapharm in more than 70 countries completed