EXFORGE HCT Drug Patent Profile

Which patents cover Exforge Hct, and what generic alternatives are available?

Exforge Hct is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for EXFORGE HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	15
Drug Prices:	Drug price information for EXFORGE HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXFORGE HCT
What excipients (inactive ingredients) are in EXFORGE HCT?	EXFORGE HCT excipients list
DailyMed Link:	EXFORGE HCT at DailyMed

See drug prices for EXFORGE HCT

Recent Clinical Trials for EXFORGE HCT

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

Sponsor	Phase
International Bio service	Phase 1
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1

See all EXFORGE HCT clinical trials

Pharmacology for EXFORGE HCT

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for EXFORGE HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	10 mg/12.5 mg/ 160 mg	022314	1	2009-10-22
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg	022314	1	2009-09-14

US Patents and Regulatory Information for EXFORGE HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes

Expired US Patents for EXFORGE HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	6,294,197*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	5,399,578*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	6,294,197*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	5,399,578*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	5,399,578*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	5,399,578*PED
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	8,101,599

International Patents for EXFORGE HCT

When does loss-of-exclusivity occur for EXFORGE HCT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Ecuador

European Patent Office

Hong Kong

Japan

Mexico

Morocco

New Zealand

Norway

Peru

Russian Federation

South Africa

South Korea

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EXFORGE HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	300285
Japan	4969338
Luxembourg	91347
South Korea	20050092054
Argentina	061627
Finland	910747
European Patent Office	1774967

Supplementary Protection Certificates for EXFORGE HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
1915993	C300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983	CA 2010 00014	Denmark
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK

Market Dynamics and Financial Trajectory for EXFORGE HCT

Last updated: July 27, 2025

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Introduction

EXFORGE HCT represents a significant development in the pharmaceutical landscape, primarily targeting hypertension and associated cardiovascular risks. As a fixed-dose combination therapy, it merges two active ingredients: efonidipine, a calcium channel blocker, and hydrochlorothiazide (HCTZ), a diuretic. This analysis explores the market dynamics influencing EXFORGE HCT's performance, its potential financial trajectory, and strategic considerations critical for stakeholders.

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Overview of EXFORGE HCT and Its Therapeutic Positioning

EXFORGE HCT offers a synergistic approach to managing hypertension, a condition affecting over one billion globally. The therapy's pharmacological profile leverages the vasodilatory effects of efonidipine with the diuretic action of HCTZ, resulting in effective blood pressure control with the convenience of a single pill ([1]).

The drug's formulation caters to patients with resistant hypertension, where monotherapy proves insufficient. Its inclusion in guidelines like the European Society of Cardiology underscores its clinical relevance, facilitating broader adoption.

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Market Size and Growth Drivers

Global Hypertension Market Expansion

The global antihypertensive drugs market was valued at approximately USD 23 billion in 2022 and is projected to grow at a CAGR of 3-5% through 2030 ([2]). Key growth drivers include rising hypertension prevalence, aging populations, lifestyle factors, and improved diagnosis rates.

Shift Toward Fixed-Dose Combinations

Fixed-dose combination (FDC) drugs like EXFORGE HCT are increasingly favored for their improved adherence and simplified regimens. The FDC segment's CAGR is notably higher, around 6-8%, driven by clinical guidelines favoring combination therapy for resistant cases.

Regional Market Dynamics

• North America: Leading the market due to high hypertension prevalence, healthcare infrastructure, and favorable regulatory environments.
• Europe: Growing acceptance, with a focus on combination therapies for resistant hypertension.
• Asia-Pacific: Rapidly expanding market driven by urbanization, increasing hypertension prevalence, and improving healthcare access.

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Competitive Landscape and Market Penetration

The antihypertensive market features well-established drugs—such as amlodipine, losartan, and hydrochlorothiazide alone, and various combination therapies. The introduction of EXFORGE HCT faces competition from branded and generic FDCs. However, its unique formulation and clinical benefits could offer differentiation.

Key competitors include:

• Amlodipine/Benazepril (Once-daily combination)
• Losartan/HCTZ
• Other efonidipine-based combinations

Market entry barriers include patent statuses, insurance reimbursement policies, and physician acceptance. A strong clinical profile and targeted marketing are crucial for market penetration and brand recognition.

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Regulatory Considerations and Patent Landscape

EXFORGE HCT's regulatory pathway involves navigating approvals across diverse jurisdictions. Its patent status offers limited exclusivity, particularly if generics enter the market, emphasizing the need for strategic patent management and lifecycle planning.

Regulatory agencies like the FDA and EMA emphasize demonstrating bioequivalence, safety, and efficacy. Given the widespread use of HCTZ and calcium channel blockers, demonstrating added value—such as improved safety profile or dosing convenience—is vital.

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Pricing Strategies and Reimbursement

Pricing will influence its market share, especially in price-sensitive regions. Premium positioning can be justified through clinical benefits, adherence metrics, and formulary placements.

Reimbursement coverage hinges on health technology assessments (HTA), which evaluate cost-effectiveness. Positive HTA outcomes in key markets could facilitate reimbursement and wider adoption.

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Financial Trajectory and Revenue Projections

Assuming favorable market entry conditions and sustained demand, EXFORGE HCT’s revenue trajectory can be modeled based on:

• Market penetration rates
• Pricing assumptions
• Patient adoption rates
• Regulatory and competitive factors

Initial Year (Year 1-2): Focused on launching in North America and Europe, capturing 1-3% of the hypertensive FDC market, translating to USD 50-150 million in revenue.

Mid-term (Year 3-5): Expansion into Asia-Pacific and emerging markets. Penetration could reach 10% of the FDC segment, generating USD 300-600 million annually.

Long-term (Year 6+): Market saturation and lifecycle management strategies, including new formulations or indications, could sustain revenues in excess of USD 1 billion globally.

These projections hinge on factors such as patient adherence improvements, clinician acceptance, competitive actions, and regulatory approvals.

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Strategic Opportunities and Challenges

Opportunities:

• Increasing demand for combination therapies.
• Growing prevalence of resistant hypertension.
• Emerging markets' expanding healthcare infrastructure.

Challenges:

• Competitive threats from generic drugs.
• Regulatory hurdles delaying approvals.
• Pricing pressures and reimbursement barriers.

Aggressive branding, clinical evidence, and diversification into additional indications or formulations can mitigate these challenges.

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Conclusion

EXFORGE HCT's success hinges on navigating complex market dynamics, including rising hypertension prevalence, evolving treatment guidelines favoring combination therapies, and competitive pressures. Its financial trajectory is promising, with potential to generate substantial revenues if strategic positioning aligns with market needs, regulatory pathways, and payer incentives.

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Key Takeaways

• EXFORGE HCT is positioned within a growing market targeting resistant hypertension, a significant global health concern.
• Fixed-dose combinations continue to outpace monotherapies in growth, driven by adherence benefits and clinical guidelines.
• Strategic regulatory, pricing, and marketing initiatives are essential to penetrate competitive markets effectively.
• Revenue prospects are optimistic, with potential for exceeding USD 1 billion globally, contingent on successful implementation.
• Lifecycles can be extended through innovation, portfolio expansion, and entering emerging markets.

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FAQs

1. What distinguishes EXFORGE HCT from other antihypertensive FDCs?
   Its combination of efonidipine and hydrochlorothiazide offers a unique pharmacodynamic profile, potentially improving blood pressure control in resistant cases with a favorable safety profile, aligning with recent clinical guidelines.

2. Which markets present the most significant growth opportunities for EXFORGE HCT?
   North America and Europe provide immediate opportunities due to high prevalence and healthcare infrastructure, while Asia-Pacific holds expansive long-term growth potential driven by increasing hypertension rates and expanding healthcare access.

3. What barriers could impede EXFORGE HCT’s market success?
   Patent limitations, competition from generics, regulatory delays, pricing constraints, and physician acceptance pose notable hurdles.

4. How can EXFORGE HCT maintain competitiveness amid generic entry?
   Through clinical differentiation, demonstrating improved efficacy or safety, securing favorable reimbursement terms, and establishing strong brand recognition.

5. What strategic moves could optimize the financial trajectory of EXFORGE HCT?
   Expanding indications, entering emerging markets with tailored pricing, investing in clinical research, and forming strategic alliances for distribution and marketing.

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References

[1] European Society of Cardiology Guidelines, 2021.
[2] Global Data, Antihypertensive Drugs Market Report, 2022.