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:	6
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
AgoneX Biopharmaceuticals, Inc.	Phase 2
BioHealthonomics 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	021093-001	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008

International Patents for ATACAND HCT

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

Country	Patent Number	Title	Estimated Expiration
China	1086998
European Patent Office	0782852	Compositions pharmaceutiques comprenant d'antagonistes à angiotensin-II et des produits huileux destinés à l'utilisation orale et une méthode pour leur préparation (Pharmaceutical compositions of heterocyclic angiotensin-II antagonists and oily substances for oral use and method of preparing them)
Canada	2040955	DERIVES DU BENZIMIDAZOLE, LEUR PRODUCTION ET LEUR UTILITE (BENZIMIDAZOLE DERIVATIVES, THEIR PRODUCTION AND USE)

Supplementary Protection Certificates for ATACAND HCT

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

ATACAND HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ATACAND HCT

Introduction

ATACAND HCT, a combination of candesartan cilexetil and hydrochlorothiazide, is a prescription medication indicated for the treatment of hypertension. This article delves into the market dynamics and financial trajectory of ATACAND HCT, highlighting key agreements, sales performance, and strategic shifts in its commercialization.

Indications and Usage

ATACAND HCT is approved for the management of hypertension, particularly when monotherapy with either candesartan or hydrochlorothiazide is not sufficiently effective. It is part of a comprehensive cardiovascular risk management strategy that includes lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake[3].

Market Presence and Commercial Rights

AstraZeneca, the original developer of ATACAND and ATACAND HCT, has undergone significant changes in the commercial rights of these medications.

European Market

In 2018, AstraZeneca agreed to divest the commercial rights of ATACAND and ATACAND HCT in Europe to Cheplapharm Arzneimittel GmbH. This agreement was part of AstraZeneca's strategy to streamline its portfolio of mature medicines and reinvest in newer therapies. Cheplapharm paid $200 million upfront, plus a time-bound payment of $10 million and sales-contingent milestones[5].

Global Market

In a subsequent move, AstraZeneca divested the commercial rights of ATACAND and ATACAND HCT in more than 70 countries to Cheplapharm in 2020. This deal included a total consideration of $400 million, with $250 million payable upon completion and the remainder in the first half of 2021. AstraZeneca will continue to manufacture and supply the medications during a three-year transition period[1].

Financial Performance

The financial performance of ATACAND and ATACAND HCT has been significant, although it has seen fluctuations over the years.

Global Sales

In 2017, global product sales for ATACAND and ATACAND HCT were $300 million, with $86 million of that coming from Europe. This revenue did not impact AstraZeneca's financial guidance for 2018 or 2020[1][5].

Royalty Income

ANI Pharmaceuticals, which acquired the rights to market ATACAND and ATACAND HCT under its label, reported significant royalty income from these products. In the second quarter of 2018, ANI received $4.9 million in royalties from the sales of these medications, among others. However, this income decreased by 80% in the third quarter of 2019 following the launch of these products under ANI's label, as the sales were then included in the branded pharmaceutical products segment[2][4].

Strategic Implications

The divestment of ATACAND and ATACAND HCT is part of AstraZeneca's broader strategy to focus on newer medicines in its main therapy areas.

Reinvestment in Main Therapy Areas

AstraZeneca aims to reinvest the proceeds from these divestments into its core therapy areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory. This strategy is designed to bring innovative new medicines to patients and enhance the company's competitive position in these markets[1][5].

Cheplapharm's Role

Cheplapharm, with its strong presence in Europe and now in over 70 countries globally, is expected to expand the commercial potential of ATACAND and ATACAND HCT. This partnership ensures continued patient access to these medications while allowing AstraZeneca to focus on its strategic priorities[1][5].

Market Dynamics and Competition

The hypertension market is highly competitive, with various antihypertensive drugs available from different pharmacologic classes.

Comprehensive Cardiovascular Risk Management

ATACAND HCT is part of a broader approach to managing cardiovascular risk, which includes lifestyle changes and other pharmacological interventions. The medication's effectiveness in lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events makes it a valuable option in this market[3].

Generic and Branded Competition

The launch of generic versions of ATACAND and ATACAND HCT, as well as the presence of other branded antihypertensive medications, influences the market dynamics. ANI Pharmaceuticals' acquisition and re-launch of these products under its label have also impacted the competitive landscape[2][4].

Future Outlook

The future outlook for ATACAND HCT is shaped by the ongoing transition of commercial rights and the evolving market for antihypertensive medications.

Transition Period

During the three-year transition period, AstraZeneca will continue to manufacture and supply ATACAND and ATACAND HCT, ensuring a smooth handover to Cheplapharm. This period is crucial for maintaining patient access and market stability[1].

Market Evolution

As the hypertension market continues to evolve with new treatments and guidelines, ATACAND HCT remains a significant player. Its effectiveness and the strong commercial presence of Cheplapharm are expected to sustain its market position[3].

Key Takeaways

• Divestment Strategy: AstraZeneca's divestment of ATACAND and ATACAND HCT to Cheplapharm is part of its strategy to focus on newer medicines.
• Financial Impact: The divestment generated significant revenue for AstraZeneca, with $400 million from the global deal.
• Market Presence: Cheplapharm's strong presence in Europe and globally ensures continued patient access and commercial potential for ATACAND HCT.
• Comprehensive Management: ATACAND HCT is part of a broader approach to cardiovascular risk management.
• Competitive Landscape: The market is competitive, with generic and branded options available, but ATACAND HCT remains a valuable treatment option.

FAQs

Q: What are the indications for ATACAND HCT? A: ATACAND HCT is indicated for the treatment of hypertension, particularly when monotherapy with either candesartan or hydrochlorothiazide is not sufficiently effective[3].

Q: Who acquired the commercial rights to ATACAND and ATACAND HCT from AstraZeneca? A: Cheplapharm Arzneimittel GmbH acquired the commercial rights to ATACAND and ATACAND HCT from AstraZeneca in Europe and over 70 countries globally[1][5].

Q: How much did Cheplapharm pay for the commercial rights in the global deal? A: Cheplapharm paid a total of $400 million for the commercial rights, with $250 million payable upon completion and the remainder in the first half of 2021[1].

Q: What is AstraZeneca's strategy behind divesting ATACAND and ATACAND HCT? A: AstraZeneca aims to focus on newer medicines in its main therapy areas by divesting mature medicines like ATACAND and ATACAND HCT[1][5].

Q: How does ATACAND HCT fit into comprehensive cardiovascular risk management? A: ATACAND HCT is part of a broader approach to managing cardiovascular risk, including lifestyle changes and other pharmacological interventions to lower blood pressure and reduce cardiovascular events[3].

Sources

1. AstraZeneca Press Release: "Atacand to be divested to Cheplapharm in more than 70 countries" - October 30, 2020.
2. ANI Pharmaceuticals Financial Report: "ANI Pharmaceuticals Reports Second Quarter and Year-To-Date 2018" - August 7, 2018.
3. FDA Label: "ATACAND HCT" - August 20, 2020.
4. ANI Pharmaceuticals Financial Report: "ANI Pharmaceuticals Reports Third Quarter Results" - November 5, 2019.
5. AstraZeneca Press Release: "Atacand to be divested to Cheplapharm in Europe" - July 24, 2018.