AMLODIPINE BESYLATE; TELMISARTAN - Generic Drug Details

What are the generic drug sources for amlodipine besylate; telmisartan and what is the scope of freedom to operate?

Amlodipine besylate; telmisartan is the generic ingredient in two branded drugs marketed by Alembic, Lupin Ltd, Mylan, Torrent, and Boehringer Ingelheim, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; TELMISARTAN

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	2
DailyMed Link:	AMLODIPINE BESYLATE; TELMISARTAN at DailyMed

Pharmacology for AMLODIPINE BESYLATE; TELMISARTAN

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; TELMISARTAN

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for AMLODIPINE BESYLATE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	TELMISARTAN AND AMLODIPINE	amlodipine besylate; telmisartan	TABLET;ORAL	205234-001	Nov 17, 2016		DISCN	No	No
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-003	Oct 16, 2009		DISCN	Yes	No
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009		DISCN	Yes	No
Mylan	TELMISARTAN AND AMLODIPINE	amlodipine besylate; telmisartan	TABLET;ORAL	202516-002	Aug 26, 2014	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-001	Oct 16, 2009	5,591,762
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009	5,591,762
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-003	Oct 16, 2009	5,591,762
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	Oct 16, 2009	5,591,762

AMLODIPINE BESYLATE; TELMISARTAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Telmisartan

Introduction

Amlodipine besylate and telmisartan are two widely used antihypertensive medications that have significant market presence and growth potential. This article delves into the market dynamics, financial trajectories, and key factors influencing the demand for these drugs.

Amlodipine Besylate Market Overview

Market Size and Growth

The global amlodipine besylate market was valued at USD 1,867.0 million in 2023 and is projected to reach USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[3].

Drivers of Growth

• Rising Prevalence of Hypertension and Cardiovascular Diseases: The increasing incidence of hypertension and cardiovascular diseases globally is a significant driver for the amlodipine besylate market[3].
• Adoption of Combination Therapies: The growing preference for combination therapies, which often include amlodipine besylate, is another key factor driving market growth[3].
• Advancements in Pharmaceutical Formulations: Improvements in pharmaceutical formulations that enhance patient compliance and accessibility also contribute to the market's expansion[3].

Regional Analysis

• North America: This region dominated the market with a share of around 34.56% in 2023, driven by high healthcare spending, advanced infrastructure, and a strong regulatory framework[3].
• Asia Pacific: This region is expected to witness significant growth, with a CAGR of 5.09%, due to increasing awareness about cardiovascular health and government initiatives promoting preventive healthcare[3].

Telmisartan Market Overview

Market Size and Growth

The global telmisartan market was valued at USD 3,567.30 million in 2023 and is expected to reach USD 4,661.27 million by 2032, growing at a CAGR of 3.4% during the forecast period (2024–2032)[1]. Alternatively, another forecast suggests the market will be valued at USD 4.20 billion in 2024 and reach USD 5.41 billion by 2031, with a CAGR of 3.7%[4].

Drivers of Growth

• Increasing Demand for Hypertension Treatment: The primary driver is the increasing demand for effective drugs to treat hypertension. Telmisartan is prescribed for both primary hypertension treatment and to reduce the risk of cardiovascular events[4].
• Rising Healthcare Spending: Favorable government policies for hypertension prevention and control, along with rising healthcare spending, are also driving the market[1][4].
• Growing Demand for Generics: The shift towards more affordable healthcare options, particularly generic drugs, is a significant opportunity for telmisartan market players[4].

Regional Analysis

• Asia Pacific: This region is expected to grow at a higher CAGR, driven by a large patient population, increasing healthcare expenditures, and rising awareness about the use of telmisartan medications. Countries like India and China are key contributors to this growth[1][4].

Combination Therapies: Amlodipine Besylate and Telmisartan

TWYNSTA (Telmisartan/Amlodipine)

The combination of telmisartan and amlodipine, known as TWYNSTA, is indicated for patients whose blood pressure is not adequately controlled on monotherapy. This combination offers enhanced efficacy and adherence, providing a lucrative opportunity for market players[2][5].

Pharmacokinetics and Efficacy

Studies have shown that the combination of telmisartan and amlodipine results in a more rapid onset of blood pressure lowering and a significantly greater reduction in blood pressure compared to monotherapy. This additive effect makes the combination a preferred treatment option for many patients[2].

Market Challenges

Patent Expiration and Generic Competition

The expiration of patents for branded telmisartan and amlodipine besylate has led to increased competition from generic manufacturers. This shift towards generics has impacted the profit margins of innovator companies, as the average selling price of these drugs has declined[1][4].

Medication Shortages

Medication shortages, particularly for telmisartan, are expected to hinder market expansion. These shortages can disrupt supply chains and affect patient access to these essential medications[1].

Market Opportunities

Growing Demand for Generics

The increasing preference for generic drugs offers significant opportunities for companies in the telmisartan and amlodipine besylate markets. As healthcare costs rise, more patients and governments are seeking affordable treatment options, driving the expansion of the generic drug industry[4].

Emerging Markets

Developing nations, especially in Asia and LAMEA (Latin America, Middle East, and Africa), present lucrative opportunities due to a large patient base and the rising prevalence of cardiovascular diseases. Government initiatives and increasing healthcare spending in these regions are expected to fuel market growth[1][4].

Financial Trajectory

Revenue Projections

• Amlodipine Besylate: Expected to reach USD 2,539.5 million by 2031 from USD 1,867.0 million in 2023[3].
• Telmisartan: Expected to reach USD 4,661.27 million by 2032 from USD 3,567.30 million in 2023, or alternatively, USD 5.41 billion by 2031 from USD 4.20 billion in 2024[1][4].

Impact of Healthcare Spending

The rise in healthcare spending, particularly in regions like North America and Asia Pacific, is a critical factor in the financial trajectory of these drugs. Increased healthcare expenditures and government initiatives aimed at promoting preventive healthcare are expected to drive demand and revenue growth[1][3][4].

Key Takeaways

• The amlodipine besylate and telmisartan markets are driven by the rising prevalence of hypertension and cardiovascular diseases.
• Combination therapies, such as TWYNSTA, offer enhanced efficacy and adherence.
• Generic competition and medication shortages are significant challenges.
• Emerging markets, especially in Asia Pacific, present substantial growth opportunities.
• Increasing healthcare spending and government initiatives are crucial for market expansion.

FAQs

Q: What is the expected market size of the telmisartan market by 2032? A: The global telmisartan market is expected to reach USD 4,661.27 million by 2032[1].

Q: How does the combination of telmisartan and amlodipine (TWYNSTA) benefit patients? A: TWYNSTA provides a more rapid onset of blood pressure lowering and a significantly greater reduction in blood pressure compared to monotherapy, enhancing patient outcomes[2].

Q: What are the key drivers of the amlodipine besylate market? A: The key drivers include the rising prevalence of hypertension and cardiovascular diseases, adoption of combination therapies, and advancements in pharmaceutical formulations[3].

Q: How does the shift towards generic drugs impact the telmisartan market? A: The shift towards generics has led to increased competition, reducing the average selling price and impacting the profit margins of innovator companies[4].

Q: Which region is expected to witness the highest growth in the telmisartan market? A: The Asia Pacific region, particularly countries like India and China, is expected to witness the highest growth due to a large patient population and increasing healthcare expenditures[1][4].

Cited Sources

1. Straits Research - Telmisartan Market Size, Share and Forecast to 2030
2. Therapeutic Goods Administration - Australian Public Assessment Report for Telmisartan/Amlodipine
3. Kings Research - Amlodipine Besylate Market Size & Share Forecast [2031]
4. Coherent Market Insights - Telmisartan Market - Share, Size and Industry Analysis
5. FDA - TWYNSTA (telmisartan/amlodipine) Tablets