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. Eighteen 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

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

International Patents for LOTREL

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	93387	BENZAZEPIN-2-ONES
Denmark	171257
New Zealand	219868	AMLODIPINE SALTS (3 ETHYL 5-METHYL -2-(AMINOETHOXYMETHYL)- 4-(2-CHLOROPHENYL)-1,4-DIHYDRO-6-METHYLPYRIDINE-3,5- DICARBOXYLATE) AND PHARMACEUTICAL COMPOSITIONS
Croatia	P930370	PROCESS FOR THE PREPARATION OF 1,4 DIHYDROPYRIDINE
South Korea	900001191

Supplementary Protection Certificates for LOTREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016

Last updated: February 3, 2026

mmary
LOTREL (amlodipine besylate and benazepril hydrochloride) is a combination antihypertensive medication. Its market presence is supported by strong demand in hypertension management, with a focus on cardiovascular health. Its investment outlook depends on patent status, competitive landscape, regulatory approval, and market penetration. Fundamental analysis indicates steady revenue growth, but potential patent expirations and generic competition could pressure margins.

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What Is the Market Position of LOTREL?

LOTREL is marketed by Novartis and has been a prominent choice for hypertensive patients since its approval in 2007. It combines amlodipine, a calcium channel blocker, with benazepril, an ACE inhibitor, creating a dual-action medication for reducing blood pressure.

Market Share and Sales Data

• Estimated global sales: Approximately $600 million in 2022 ([1])
• Market penetration in the U.S.: Among top prescribed antihypertensives, especially in combination therapy
• CHA: Shares a segment with similar combination drugs like Hyzaar (losartan/hydrochlorothiazide) and various generic equivalents

Sales Drivers

• Rising prevalence of hypertension globally
• Uptake in developing markets due to increasing healthcare infrastructure
• FDA approvals for additional indications or combination formats could influence future sales

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How Does Patent and Regulatory Landscape Affect Investment?

Patent Status

• Original patent expiration: Around 2013-2014 in the U.S. ([2])
• Generic versions: Authorized generics and other firms now market AB-rated equivalents
• Patent litigation or new formulations could prolong exclusivity

Regulatory Approvals and Formulation Changes

• Current approvals: U.S. FDA, EMA, and other global health agencies
• Pending or recent formulations: Fixed-dose combinations or extended-release versions may provide revenue opportunities
• Regulatory hurdles: Any delays or failures in new formulations can impact growth

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What Are the Competitive Dynamics and Risks?

Generic Competition

• The availability of generics significantly diminishes profit per unit
• Price erosion: Margins can decline by 40-60% following generic entry ([3])

Other Drugs in Hypertension Segment

• Drugs with better side-effect profiles or simplified dosing, including newer classes such as ARNI or SGLT2 inhibitors, target similar patient groups
• The penetration of these newer classes may reduce LOTREL’s market share over time

Market Risks

• Shifts toward personalized medicine and alternative therapies
• Regulatory changes affecting combination drugs or patent protections

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What Are the Revenue and Financial Fundamentals?

Revenue Trends

• Stable revenue in the last five years largely driven by existing patient base
• Growth: Low to mid-single digits annually before generic competition
• Cost of goods sold (COGS): Approximate 20-25% of sales, stable over time

Profitability and Margins

• Gross margin: Approximately 65% in the branded phase, declines with generics
• R&D expenses: Moderate for a mature drug, around 10-15% of sales
• Operating margins: Historically 30-35%, likely to decline as generics dominate

Pipeline and Future Growth

• Limited pipeline specific to LOTREL; growth relies on market expansion and new formulations
• Licensing or new combination therapies could provide upside

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Is There Regulatory or Patent-Related Key Risk?

Patent Risks

• Loss of patent protection leads to generic competition and price compression
• Patent challenges or new formulation patents could temporarily extend exclusivity

Regulatory Risks

• Any adverse regulatory decision or safety concern could hamper sales
• Potential for formulary exclusions or reimbursement reductions in public sectors

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Investment Outlook Summary

Aspect	Assessment	Implication
Market Potential	Steady demand due to hypertension prevalence	Maintains baseline revenue
Patent Status	Patent expired, generics dominating	Revenue pressure, margins squeezed
Competition	Intense with multiple generics	Margins reduce over time
Regulatory Risks	Moderate; depends on safety data	Significant if safety issues arise
Pipeline	Limited; growth depends on market expansion	Low upside unless new formulations introduced

Key Takeaways

• LOTREL remains a significant antihypertensive medication but faces revenue decline due to patent expirations and generic competition.
• Its future depends on market expansion, development of new formulations, or combination therapies.
• While margins are declining, the drug maintains a stable revenue base driven by chronic disease prevalence.
• Competitive pressures may impact profitability; investments should consider lifecycle management strategies.
• Regulatory and patent-related risks are manageable but require monitoring for potential patent challenges or safety concerns.

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FAQs

1. What is the current patent status of LOTREL?
The original patents expired around 2013-2014 in the U.S. and other markets, leading to widespread generic availability.

2. How does generic competition affect LOTREL’s revenue?
Generics significantly reduce the drug's price, typically by 40-60%, eroding profit margins and limiting revenue growth.

3. Are there new formulations or indications for LOTREL?
No; the core formulation remains unchanged, with growth primarily from market expansion rather than innovation.

4. What are the primary market risks for investors?
The main risks include loss of patent exclusivity, competitive market entries, and potential regulatory issues related to safety or reimbursement.

5. What is the outlook for hypertensive drugs globally?
The increasing prevalence of hypertension and cardiovascular diseases supports steady demand, but evolving treatment standards and generics pressure are constraints.

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Sources

[1] IMS Health (IQVIA), 2022 Sales Data
[2] U.S. Patent Office records, patent expiration calendar
[3] MarketData Reports, 2022