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. Fifteen 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
Patent Applications:	4,296
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

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	020364-007	Apr 11, 2006
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
Argentina	242562	UN PROCEDIMIENTO PARA PREPARAR LA SAL BESILATO DE AMLODIPINA. (SALTS OF AMLODIPINE)
New Zealand	207091	SUBSTITUTED BENZAZEPINONES AND PHARMACEUTICAL COMPOSITIONS
Ireland	863092
Austria	18397

Supplementary Protection Certificates for LOTREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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 Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lotrel

Introduction to Lotrel

Lotrel, a fixed-dose combination of amlodipine and benazepril, is a widely used antihypertensive drug. It is indicated for the treatment of hypertension and has been a significant player in the antihypertensive drugs market.

Market Size and Growth

The global antihypertensive drugs market, which includes Lotrel, is projected to see substantial growth. As of 2023, the amlodipine besylate market, a component of Lotrel, was valued at USD 1,867.0 million and is expected to reach USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[1].

Key Growth Factors

Several factors contribute to the growth of the market for Lotrel and similar antihypertensive drugs:

Rising Prevalence of Hypertension

The increasing prevalence of hypertension, driven by aging populations, sedentary lifestyles, and poor dietary habits, is a major driver. Hypertension is a significant risk factor for cardiovascular diseases, which are among the leading causes of death globally[1].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations that enhance patient compliance and accessibility also play a crucial role. Combination therapies like Lotrel, which combine an ACE inhibitor (benazepril) and a calcium channel blocker (amlodipine), offer additive and sometimes synergistic blood pressure lowering effects[5].

Online Retail and E-commerce

The shift towards online retail is another significant factor. The online retail segment for pharmaceuticals, including antihypertensive drugs, is expected to grow at a CAGR of 4.67% during the forecast period, driven by the convenience and accessibility of e-commerce platforms[1].

Regional Analysis

North America

North America holds a significant share of the amlodipine besylate market, with a valuation of USD 645.2 million in 2023. This dominance is due to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage in the region[1].

Asia Pacific

The Asia Pacific region is poised for rapid growth, with a CAGR of 5.09% over the forecast period. This growth is driven by increasing awareness of cardiovascular health and government initiatives promoting preventive healthcare and early treatment[1].

Sales Channels

The market for Lotrel is segmented by sales channels into hospital pharmacies, drug store & pharmacies, online retails, and others. The online retail segment is expected to see significant growth due to the increasing adoption of e-commerce for purchasing medications, which offers convenience, accessibility, and competitive pricing[1].

Competitive Landscape

Major pharmaceutical companies are investing in marketing strategies to differentiate their branded products from generic competitors. They are also expanding their online sales channels and investing in R&D to develop novel formulations. Strengthening collaborations with healthcare providers to highlight the clinical benefits of their products is another strategy to maintain market share in the face of growing competition[1].

Financial Performance

The financial performance of the antihypertensive drugs market, including Lotrel, is robust. Here are some key financial indicators:

Market Value

The global amlodipine besylate market, which includes Lotrel, is projected to reach USD 2,539.5 million by 2031 from USD 1,867.0 million in 2023[1].

Revenue Growth

The market is expected to grow at a CAGR of 3.98% from 2024 to 2031, driven by the factors mentioned above[1].

Regional Revenue

North America, with its high prevalence of hypertension and advanced healthcare infrastructure, contributes significantly to the revenue. The region's valuation was USD 645.2 million in 2023[1].

Challenges and Opportunities

Generic Competition

One of the challenges faced by branded antihypertensive drugs like Lotrel is the increasing competition from generic alternatives. However, companies are addressing this by investing in R&D to develop novel formulations and enhancing their marketing strategies[1].

Regulatory Environment

A strong regulatory framework, particularly in regions like North America, supports the market growth by ensuring broad access to these medications and promoting early diagnosis and effective disease management[1].

Key Takeaways

• The global antihypertensive drugs market, including Lotrel, is expected to grow significantly due to the rising prevalence of hypertension and advancements in pharmaceutical formulations.
• Online retail is becoming a crucial sales channel, driven by convenience and accessibility.
• North America and the Asia Pacific region are key markets, with North America dominating due to high healthcare spending and advanced infrastructure.
• Companies are focusing on R&D and marketing strategies to maintain their market share.

FAQs

Q1: What is the projected market size for the amlodipine besylate market by 2031? The amlodipine besylate market is projected to reach USD 2,539.5 million by 2031[1].

Q2: What are the key growth factors for the antihypertensive drugs market? Key growth factors include the rising prevalence of hypertension, advancements in pharmaceutical formulations, and the increasing adoption of online retail for purchasing medications[1].

Q3: Which region dominates the amlodipine besylate market? North America dominates the amlodipine besylate market, with a valuation of USD 645.2 million in 2023[1].

Q4: How is the shift to online retail impacting the market? The shift to online retail is expected to grow at a CAGR of 4.67% during the forecast period, driven by convenience, accessibility, and competitive pricing[1].

Q5: What strategies are pharmaceutical companies using to maintain market share? Pharmaceutical companies are investing in R&D to develop novel formulations, expanding their online sales channels, and strengthening collaborations with healthcare providers to highlight the clinical benefits of their products[1].

Cited Sources

1. Amlodipine Besylate Market Size & Share Forecast [2031] - Kings Research.
2. Annual Comprehensive Financial Report - Maryland State Archives - Maryland Lottery and Gaming Control Agency.
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - National Bureau of Economic Research.
4. Antihypertensive Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst.
5. Lotrel - accessdata.fda.gov - U.S. Food and Drug Administration.