Telmisartan - Generic Drug Details

What are the generic sources for telmisartan and what is the scope of patent protection?

Telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for telmisartan. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for telmisartan

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	272
Patent Applications:	7,147
Drug Prices:	Drug price trends for telmisartan
Drug Sales Revenues:	Drug sales revenues for telmisartan
What excipients (inactive ingredients) are in telmisartan?	telmisartan excipients list
DailyMed Link:	telmisartan at DailyMed

See drug prices for telmisartan

See drug sales revenues for telmisartan

Recent Clinical Trials for telmisartan

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

Sponsor	Phase
Tyler J Curiel	Early Phase 1
THPharm Corp.	Phase 1
HK inno.N Corporation	Phase 1

See all telmisartan clinical trials

Generic filers with tentative approvals for TELMISARTAN

Applicant	Application No.	Strength	Dosage Form
		80MG; 25MG	TABLET; ORAL
		80MG; 12.5MG	TABLET; ORAL
		40MG; 12.5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for telmisartan

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for telmisartan

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

Paragraph IV (Patent) Challenges for TELMISARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MICARDIS	Tablets	telmisartan	20 mg, 40 mg and 80 mg	020850	1	2006-12-26

US Patents and Regulatory Information for telmisartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	204415-002	Sep 8, 2015	AB	RX	No	No
Hetero Labs Ltd V	TELMISARTAN	telmisartan	TABLET;ORAL	205901-002	Apr 22, 2016	AB	RX	No	No
Zydus Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	203325-003	Aug 26, 2014	AB	RX	No	No
Micro Labs	TELMISARTAN	telmisartan	TABLET;ORAL	207016-002	Oct 3, 2017	AB	RX	No	No
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-003	May 3, 2017	AB	RX	No	No

Expired US Patents for telmisartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998

EU/EMA Drug Approvals for telmisartan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Micardis	telmisartan	EMEA/H/C/000209 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type-2 diabetes mellitus with documented target-organ damage.	Authorised	no	no	no	1998-12-16
Krka, d.d., Novo mesto	Tolura	telmisartan	EMEA/H/C/001196 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.	Authorised	yes	no	no	2010-06-04
Teva B.V.	Telmisartan Teva Pharma	telmisartan	EMEA/H/C/002511 Treatment of essential hypertension in adults.	Authorised	yes	no	no	2011-10-03
Teva B.V.	Telmisartan Teva	telmisartan	EMEA/H/C/001146 Treatment of essential hypertension in adults	Withdrawn	yes	no	no	2010-01-25
Actavis Group PTC ehf	Telmisartan Actavis	telmisartan	EMEA/H/C/001168 HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.	Authorised	yes	no	no	2010-09-29

Telmisartan Market Analysis and Financial Projection Experimental

Telmisartan Market Dynamics and Financial Trajectory

Market Overview

The global telmisartan market is poised for significant growth, driven by several key factors. As of 2023, the market was valued at USD 3,567.30 million and is projected to reach USD 4,661.27 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.4% during the forecast period of 2024-2032[1].

Key Drivers

Increasing Senior Population and Sedentary Lifestyle

The rise in the senior population and the prevalence of sedentary lifestyles are major drivers of the telmisartan market. These factors contribute to an increase in hypertension cases, for which telmisartan is a commonly prescribed medication[1].

Approval of Generic Versions

The approval of abbreviated new drug applications (ANDA) for generic telmisartan tablets has also boosted market growth. Generic versions make the medication more accessible and affordable, increasing its demand[1].

Rising Prevalence of Chronic Renal Disease

An increase in the incidence of chronic renal disease further drives the demand for telmisartan, as it is often prescribed to manage blood pressure in patients with this condition[1].

Healthcare Spending and Awareness

Increased healthcare spending and growing awareness about hypertension treatment are additional drivers. For instance, the National Heart Foundation in Australia has highlighted the importance of better hypertension management, contributing to higher demand for telmisartan[1].

Regional Market Dynamics

North America

North America dominates the global telmisartan market, with an estimated market share of 40.2% in 2024. The region's robust healthcare infrastructure, favorable reimbursement policies, and high prevalence of hypertension contribute to its market leadership[4].

Asia Pacific

The Asia Pacific region is the fastest-growing market for telmisartan, expected to grow at a CAGR of 5.5% during the forecast period. Countries like China and India, with their large patient populations and rising healthcare expenditures, drive this growth. Government initiatives to improve healthcare access and the presence of significant pharmaceutical companies also contribute to the region's rapid expansion[1][3][4].

Market Segments

Hospital Pharmacies

The Hospital Pharmacies segment is expected to generate substantial revenue, growing at a CAGR of 3.5% during the forecast period. This growth is driven by an increase in hypertension patients, the expansion of hospital pharmacies, and improvements in their structure in emerging economies like China and India[1].

Generic and Branded Drugs

The market is also influenced by the shift towards generic drugs. By 2020, around 60% of global telmisartan consumption was fulfilled by generic drug manufacturers, up from 10% prior to the 2012 patent expiration. This shift reflects a preference for more affordable healthcare options[4].

Financial Trajectory

Market Size and Growth

The global telmisartan market is estimated to be valued at USD 4.20 billion in 2024 and is expected to reach USD 5.41 billion by 2031, growing at a CAGR of 3.7% during this period[4].

Revenue and Profit Margins

While the overall consumption and volume sales of telmisartan have increased due to its widespread affordability, the average selling price has declined annually, impacting profit margins. This decline is largely due to the availability of generic substitutes once patents expire[4].

Challenges and Opportunities

Patent Expiration and Generic Substitutes

The expiration of patents for major drugs and the subsequent availability of generic substitutes pose a challenge to the market. However, this also presents an opportunity for companies to capitalize on the growing demand for generic drugs, which are more affordable and increasingly preferred by patients and governments[4].

Emerging Markets and Fixed-Dose Combinations

Emerging markets, particularly in Asia Pacific, offer lucrative opportunities due to their large patient bases and rising healthcare expenditures. Additionally, the demand for fixed-dose combinations that offer enhanced efficacy and adherence is on the rise, providing further growth opportunities for telmisartan market players[4].

Key Players and Competitive Landscape

Major players such as Zydus Cadila, Aurobindo Pharma, Cipla Inc., and Sun Pharmaceutical Industries Ltd. (Ranbaxy Laboratories) are actively contributing to the market's expansion. These companies are focusing on increasing their geographic presence in rising Asia-Pacific nations to capitalize on significant growth potential[1].

Government Policies and Healthcare Infrastructure

Favorable government policies for the prevention and control of hypertension, along with robust healthcare infrastructure in regions like North America, further support market growth. Strategic initiatives by key market players, such as product launches and partnerships with healthcare providers, also fuel market expansion[3][4].

Illustrative Statistics

• Global Market Size (2023): USD 3,567.30 million[1]
• Projected Market Size (2032): USD 4,661.27 million[1]
• CAGR (2024-2032): 3.4%[1]
• Asia Pacific CAGR: 5.5%[1]
• North America Market Share: 40.2% in 2024[4]
• Generic Drug Consumption: 60% of global consumption in 2020[4]

Key Takeaways

• The global telmisartan market is driven by an aging population, sedentary lifestyles, and increasing healthcare spending.
• The Asia Pacific region is the fastest-growing market due to its large patient base and rising healthcare expenditures.
• Generic versions of telmisartan are increasingly popular, impacting profit margins but offering growth opportunities.
• Key players are expanding their presence in emerging markets to capitalize on growth potential.
• Favorable government policies and robust healthcare infrastructure support market growth.

FAQs

Q: What is the projected growth rate of the global telmisartan market from 2024 to 2031? A: The global telmisartan market is expected to grow at a CAGR of 3.7% from 2024 to 2031[4].

Q: Which region is expected to dominate the telmisartan market in the forecast period? A: North America is expected to dominate the market, but the Asia Pacific region is the fastest-growing segment[1][4].

Q: What are the key drivers of the telmisartan market? A: Key drivers include the increasing senior population, sedentary lifestyles, approval of generic versions, and rising healthcare spending[1].

Q: How has the shift to generic drugs impacted the telmisartan market? A: The shift to generic drugs has increased market volume but reduced average selling prices, impacting profit margins[4].

Q: What are the opportunities for telmisartan market players in emerging markets? A: Emerging markets offer opportunities due to large patient bases, rising healthcare expenditures, and the growing demand for fixed-dose combinations and generic drugs[4].

Cited Sources

1. Straits Research: Telmisartan Market Size, Share and Forecast to 2030[1]
2. OpenPR: Telmisartan Market Segment Size, Growth, and Trends Forecast[2]
3. Reanin: Telmisartan Market | Growth | Share | Size | Trends and Forecast[3]
4. Coherent Market Insights: Telmisartan Market - Share, Size and Industry Analysis[4]