LOTREL Drug Patent Profile

When do Lotrel patents expire, and when can generic versions of Lotrel launch?

Lotrel is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotrel

A generic version of LOTREL was approved as amlodipine besylate; benazepril hydrochloride by LUPIN PHARMS on February 5^th, 2010.

Summary for LOTREL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	9
Drug Prices:	Drug price information for LOTREL
What excipients (inactive ingredients) are in LOTREL?	LOTREL excipients list
DailyMed Link:	LOTREL at DailyMed

See drug prices for LOTREL

See drug sales revenues for LOTREL

Recent Clinical Trials for LOTREL

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Teva Pharmaceuticals USA	Phase 1
Dr. Reddy's Laboratories Limited	Phase 1

See all LOTREL clinical trials

Pharmacology for LOTREL

Drug Class	Angiotensin Converting Enzyme Inhibitor Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for LOTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	5 mg/40 mg and 10 mg/40 mg	020364	1	2006-11-17
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg	020364	1	2004-06-09

US Patents and Regulatory Information for LOTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-007	Apr 11, 2006	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-006	Apr 11, 2006	AB	RX	Yes	Yes
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002	AB	RX	Yes	No

Expired US Patents for LOTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995	4,572,909
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002	4,879,303
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-007	Apr 11, 2006	6,162,802
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	4,410,520*PED
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995	4,410,520*PED
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	4,410,520*PED
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-006	Apr 11, 2006	4,879,303

International Patents for LOTREL

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

Country	Patent Number	Title	Estimated Expiration
Sweden	463457	BENSENSULFONATSALTET AV AMLODIPIN, FARMACEUTISKA BEREDNINGSFORMER DAERAV OCH ANVAENDNING AV SALTET FOER BEHANDLING AV HJAERTSJUKDOM ELLER HYPERTENSION
Spain	544259
Spain	544256
South Korea	900009023
Italy	1203853	SALI DI AMLODIPINA FARMACEUTICAMENTE ACCETTABILI, MIGLIORATI
South Korea	900001192
Argentina	243165	PROCEDIMIENTO PARA OBTENER NOVEDOSOS ACIDOS 3-(5-AMINOPENTIL)-AMINO-1-BENZACEPIN-2-ONA-1-ALCANOICOS. (3-AMINO-(1)-BENZAZEPIN-2-ONE-1-ALKANOIC ACIDS)

Supplementary Protection Certificates for LOTREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
0089167	SPC/GB93/046	United Kingdom		SPC/GB93/046: 20040307
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LOTREL

Last updated: July 27, 2025

Introduction

LOTREL (amlodipine besylate and benazepril hydrochloride) is a combination antihypertensive medication primarily prescribed for managing high blood pressure, a leading risk factor for cardiovascular diseases worldwide. Since its launch, LOTREL has established itself as a pivotal therapy due to its combined action on calcium channels and renin-angiotensin systems, which enhances efficacy and reduces adherence issues associated with monotherapy. This article provides a comprehensive analysis of the current market dynamics and forecasts the financial trajectory of LOTREL within the evolving pharmaceutical landscape.

Market Landscape Overview

Global Hypertension Treatment Market

The global hypertension treatment market was valued at approximately USD 28 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 3.5% from 2023 to 2030 [1]. Growth drivers include increasing prevalence of hypertension driven by aging populations, obesity, and lifestyle factors, alongside advances in antihypertensive pharmacotherapy. Countries with emerging economies exhibit rapid uptake due to better healthcare access, expanding the market footprint.

Role of Combination Drugs

Combination therapies like LOTREL contribute significantly to this growth, accounting for nearly 20% of antihypertensive prescriptions globally [2]. Fixed-dose combinations (FDCs) improve patient adherence, simplify regimens, and reduce adverse effects, which are critical in hypertension management, especially among elderly populations with polypharmacy.

Competitive Landscape

LOTREL faces competition from various monotherapies and combination drugs, including:

• Norvasc (amlodipine) alone
• Benicar (olmesartan)
• Other FDCs such as Exforge (amlodipine/valsartan) and Tarka (triamterene and verapamil)

Major players include Pfizer (originator of LOTREL), Novartis, AstraZeneca, and Teva Pharmaceuticals. Patent expirations and generic entries influence market shares, with generic versions of both amlodipine and benazepril now available, impacting pricing and profitability.

Market Dynamics Influencing LOTREL

Patent Status and Generic Competition

While LOTREL's patent protections granted exclusivity in many regions, patent expirations have introduced generic equivalents, leading to price erosion. In the U.S., the patent expired in 2019, allowing generics to enter the market, significantly affecting revenue streams for Pfizer. Nonetheless, brand loyalty and physician prescribing patterns sustain some sales volumes.

Regulatory Environment

Stringent regulatory frameworks, especially concerning cardiovascular drugs, influence market entry, labeling, and post-market surveillance. Regulatory pathways for combination drugs face complexity, with approvals depending on demonstrating bioequivalence and safety.

Clinical Guidelines and Prescribing Trends

Guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) advocate for combination therapy as the initial or early treatment for stage 2 hypertension, reinforcing demand for drugs like LOTREL [3]. Physicians favor FDCs due to improved blood pressure control and patient compliance.

Patient Demographics and Epidemiology

Rapidly aging populations, notably in North America and Europe, augur increased treatment needs. The World Health Organization estimates that approximately 1.28 billion adults had hypertension globally in 2019, expected to rise further [4]. Uncontrolled hypertension remains a key driver for initiating combination therapy.

Healthcare Systems and Reimbursement Policies

Insurance coverage, especially in developed markets, enhances access to pricier branded drugs. Conversely, cost pressures lead to preference for generics. Some health systems implement formulary restrictions on newer or branded medications, influencing sales.

Financial Trajectory of LOTREL

Historical Revenue and Market Share

Post-launch, LOTREL contributed a substantial share to Pfizer's cardiovascular portfolio. However, following patent expiry and generic entry, U.S. sales declined by approximately 30% between 2018 and 2020 [5]. Globally, Pfizer's cardiovascular segment sustained revenues but faced margin pressures.

Current Revenue Streams and Outlook

In 2022, Pfizer reported cardiovascular segment revenue of approximately USD 2.1 billion, with LOTREL’s contribution decreasing but still significant in certain markets, including emerging economies. Growth in developing regions, driven by increasing hypertension prevalence and lower-cost generics, offsets some declines.

Forecasting Future Performance

The financial trajectory hinges on several factors:

• Market Penetration of Generics: The proliferation of generic amlodipine and benazepril reduces brand revenues but expands volume sales.

• Pipeline Developments: Pfizer has been focusing on biosimilars and novel therapeutics, which may dilute focus from established drugs like LOTREL.

• Pricing Strategies: Patent expirations drive price competition; however, differentiated formulations or fixed-dose combinations can sustain premium pricing.

• Market Expansion: Increasing adoption in emerging markets with high hypertension burdens bolsters revenue streams.

Given these dynamics, analyst projections suggest a moderate decline in brand-specific revenues over the next five years, stabilizing as market share consolidates among generics and biosimilars, with potential uplift from expanding global hypertension treatment markets.

Potential Strategies to Sustain Revenue

• Patent Extensions and Formulation Innovations: New fixed-dose combinations or improved formulations may extend market life cycles.
• Market Diversification: Entry into personalized medicine or targeted therapies for hypertension comorbidities.
• Strategic Collaborations: Licensing agreements with generic manufacturers could secure a foothold amidst intense price competition.
• Increased Focus on Emerging Markets: Tailored marketing strategies can capitalize on rising healthcare access.

Conclusion

The market dynamics of LOTREL reflect broader industry trends: patent expirations, increasing generic competition, evolving clinical guidelines, and demographic shifts. While revenue erosion due to generics is imminent, continued growth in hypertension prevalence, especially in emerging markets, offers pathways for sustained profitability. Strategic innovation and market expansion remain essential for Pfizer and other stakeholders seeking to optimize the drug's financial trajectory.

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Key Takeaways

• Market growth is driven by rising global hypertension prevalence, with combination therapies like LOTREL offering clinical advantages.
• Patent expirations have led to increased generic competition, intensifying price pressures and reducing brand revenues.
• Clinical guidelines favor early combination therapy, maintaining demand despite patent challenges.
• Emerging markets present significant growth opportunities due to increasing hypertension cases and healthcare access enhancements.
• Strategic innovation—including formulation improvements and market diversification—is vital to prolong the drug's market relevance and revenue stability.

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FAQs

1. How has the patent expiration of LOTREL impacted Pfizer’s sales?
The patent expiry in 2019 led to the entry of generic versions, causing a notable decline (~30%) in U.S. sales by 2020. While revenues from LOTREL decreased, volume sales persisted, especially in regions favoring generics.

2. What strategies can Pfizer employ to maintain profitability with LOTREL?
Pfizer can focus on formulation innovations, expand into emerging markets, develop new fixed-dose combinations, and form licensing partnerships to sustain revenue and market share.

3. How does the clinical guideline environment influence LOTREL’s market?
Guidelines supporting initial combination therapy for hypertension favor drugs like LOTREL, reinforcing demand among prescribers adhering to evidence-based practices.

4. What role do generics play in the future of LOTREL?
Generics are expected to dominate the volume market, suppressing brand revenues. However, they also increase overall drug accessibility and market size, creating opportunities for volume-based growth.

5. Are there new formulations or indications for LOTREL in development?
Currently, no major new formulations or indications are publicly announced; Pfizer’s focus appears to be on optimizing existing products and expanding into new therapeutic areas.

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Sources
[1] Market Research Future, “Hypertension Treatment Market,” 2022.
[2] IMS Health, “Global antihypertensive market analysis,” 2021.
[3] American College of Cardiology/American Heart Association, “Guidelines for hypertension management,” 2017.
[4] World Health Organization, “Hypertension Fact Sheet,” 2021.
[5] Pfizer Annual Reports, 2018-2022.