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
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
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995

International Patents for LOTREL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	900001190
Croatia	P930370	PROCESS FOR THE PREPARATION OF 1,4 DIHYDROPYRIDINE
Germany	3481612
South Korea	900009023
Portugal	84611	PROCESSO PARA A PREPARACAO DE BENZENOSSULFONATO DE 2-(2-AMINOETOXIMETIL)-4-(2-CLOROFENIL)-1,4-DI-HIDRO-6-METILPIRIDINO-3,5-DICARBOXILATO 3-ETILICO 5-METILICO
Czechoslovakia	8401592

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	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
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
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

LOTREL Market Dynamics and Financial Trajectory

Last updated: April 22, 2026

What is LOTREL’s market footprint and how has it moved since launch?

LOTREL is a fixed-dose combination of amlodipine besylate + benazepril HCl, positioned for hypertension and launched in the U.S. market as a branded product. The product’s commercial trajectory is dominated by (1) patent-expiration dynamics, (2) erosion from generic ACE inhibitor plus calcium-channel blocker combinations, and (3) channel behavior typical of long-term cardiovascular antihypertensives.

Market footprint (U.S., 2020s):

• LOTREL sales declined materially as generics captured the majority of prescriptions.
• By the mid-to-late 2010s, branded volume typically shifted to niche segments, with remaining brand demand driven by prescriber preference, payer formularies, and patient continuity rather than new starts.

Commercial inflection drivers:

• Regulatory and exclusivity: After brand exclusivity ended, generic competition accelerated volume loss.
• Pricing pressure: Generic entry pulled average realized prices down even when unit volume stabilized.
• Therapeutic substitutability: Amlodipine + ACE inhibitor combinations are widely available, lowering switching costs for payers and pharmacy benefit managers.

Source for the product identity and combination components: FDA labeling database via DailyMed entry for LOTREL (amlodipine besylate and benazepril HCl) [1].

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How do patent and exclusivity timelines shape LOTREL’s financial path?

LOTREL’s revenue trajectory is structured around the standard life-cycle pattern for branded combination antihypertensives: strong early uptake, plateau around later-cycle indications and formulary penetration, then steep decline post-exclusivity.

Patent-driven commercialization pattern (high level)

• Early life cycle: Brand builds share with managed care adoption and clinician acceptance of the single-pill combination.
• Late cycle: Competition risk increases as patents approach expiration; payers pre-position with preferred generics.
• Post-expiration: Brand revenue drops as plan formularies and pharmacy channels steer to lower-priced alternatives.

What the patent landscape implies for forecasting

For investors and R&D planners, the critical takeaway is that LOTREL’s marketed value is limited by the availability of:

• Generic equivalents of the branded fixed-dose combination, and
• Therapeutic equivalents using separate generics (amlodipine + benazepril) that function as substitutes in most payer designs.

Because the product contains two well-established active ingredients with broad generic penetration, exclusivity effects typically end with limited residual brand differentiation.

Product and active ingredient composition confirmation: DailyMed [1].

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What market dynamics govern demand in cardiovascular fixed-dose combinations?

Demand dynamics for an antihypertensive fixed-dose combination are shaped by payer and prescriber behavior more than by molecule-level novelty.

Payer and channel mechanics

• Formulary placement: Once generics are available, managed care typically pushes combination brands to lower tiers or removes them from preferred status.
• Pharmacy behavior: Community dispensing trends to generics when copay differentials are material.
• Utilization management: Prior authorization or step therapy can increase switching, especially for brands after formulary changes.

Prescriber and patient behavior

• Switching friction: Fixed-dose combinations may keep some patients on the brand longer due to adherence convenience and tolerability history.
• Long prescription horizons: Cardiovascular maintenance therapy produces slower unit migration than acute therapies, which can make declines look gradual before accelerating post-formulary changes.

LOTREL composition and indication set: hypertension; single-pill amlodipine + benazepril fixed-dose regimen described in the FDA label [1].

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What financial trajectory is consistent with LOTREL’s market structure?

Given LOTREL’s nature as a fixed-dose combination of two generic-heavy actives, the consistent financial shape is:

1) Revenue and share contraction after generic entry

• Unit share declines once payers establish generic preferred status.
• Average net revenue per unit drops further as pricing compresses across channels.

2) Residual brand demand becomes limited and defensive

• Remaining brand sales typically depend on:
  • patient continuity,
  • smaller plan footprints,
  • and prescriber familiarity.

3) Profitability shifts

• Branded sales can remain profitable longer through pricing mix but margin tends to deteriorate as discounting, rebates, and trade terms respond to competitive pressure.
• Launch of generics or preferred competitors forces higher promotional and rebate costs for continued placement.

LOTREL’s fixed-dose concept and established actives support this pattern of branded erosion after generics proliferate [1].

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Where does LOTREL sit versus other antihypertensive combination strategies?

LOTREL competes in a crowded cardiovascular combination class where payers evaluate value on:

• clinical outcomes evidence,
• cost per treated patient,
• formulary tiering,
• and dosing simplicity.

Key strategic constraint for LOTREL:

• Because both components are widely available generically, cost and formulary placement dominate.

Competitive comparison logic (category-level):

• Fixed-dose ACE inhibitor + CCB combinations generally compete against:
  • separate-dose generic strategies,
  • other fixed-dose antihypertensive pairings (ACE/ARB + CCB, ACE/ARB + thiazide),
  • and newer branded combinations depending on specific payer preferences.

LOTREL’s fixed-dose structure (amlodipine + benazepril) defines the competitive set [1].

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What does this mean for R&D and investment decisions?

LOTREL is not a “molecule innovation” story; it is a life-cycle management story. The financial trajectory follows predictably from:

• broad generic availability of amlodipine and benazepril,
• generic substitution economics in hypertension,
• payer formularies that favor lower acquisition cost once equivalent options exist.

For business planning:

• New entrants into this exact combination face weak brand room unless differentiated by formulation, delivery, dosing convenience, or clinical claims supported by robust evidence.
• Investors should treat branded antihypertensive fixed-dose combinations with legacy ingredients as structurally exposed to sustained pricing pressure once generic competition is established.

Active ingredient structure: amlodipine besylate + benazepril HCl, indicated for hypertension [1].

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Key Takeaways

• LOTREL’s market dynamics are dominated by generic substitution of amlodipine + benazepril and payer formulary behavior typical of long-cycle antihypertensive maintenance therapy. [1]
• Financial trajectory follows a standard post-exclusivity pattern: share erosion, net price compression, and a move to defensive residual demand rather than new-growth momentum. [1]
• In this therapeutic class, cost and formulary tiering usually outweigh differentiation, because fixed-dose alternatives and separate generic dosing strategies are widely available. [1]

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FAQs

1) What drugs are in LOTREL?

LOTREL contains amlodipine besylate and benazepril HCl in a fixed-dose combination. [1]

2) What is LOTREL approved to treat?

LOTREL is approved for hypertension. [1]

3) Why does LOTREL face strong pricing pressure?

Both components (amlodipine and benazepril) are established antihypertensives with substantial generic availability, enabling substitution and payer switching to lower-cost options. [1]

4) How do payer formularies affect LOTREL’s demand?

Once generics exist, formularies and copay design typically steer prescriptions away from brands, reducing unit share and compressing realized net prices. [1]

5) Does LOTREL rely on clinical differentiation to sustain revenue?

In practice, LOTREL’s differentiation is limited by broad substitutability of its components; financial outcomes are driven more by exclusivity timing and channel pricing than by new clinical value creation. [1]

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References

[1] U.S. Food and Drug Administration. DailyMed. LOTREL (amlodipine besylate and benazepril hydrochloride) capsule, for oral use. https://dailymed.nlm.nih.gov/.