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, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, and Zydus Pharms, and is included in nineteen 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:	19
NDAs:	19
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	272
Patent Applications:	7,427
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; 12.5MG	TABLET; ORAL
		40MG; 12.5MG	TABLET; ORAL
		80MG; 25MG	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
Macleods Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	203986-002	Jan 15, 2025	AB	RX	No	No
Glenmark Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	090032-002	Jul 7, 2014	AB	RX	No	No
Chartwell Rx	TELMISARTAN	telmisartan	TABLET;ORAL	078710-001	Jan 8, 2014	AB	RX	No	No
Zydus Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	203325-003	Aug 26, 2014	AB	RX	No	No
Cadila Pharms Ltd	TELMISARTAN	telmisartan	TABLET;ORAL	208605-001	Jul 25, 2017	AB	RX	No	No
Hisun Pharm Hangzhou	TELMISARTAN	telmisartan	TABLET;ORAL	207843-001	Feb 19, 2019		DISCN	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	6,358,986
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000	5,591,762
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	8,003,679
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998	6,358,986
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998	5,591,762
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	5,591,762

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
Bayer AG	Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)	telmisartan	EMEA/H/C/000211 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

Telmisartan: Navigating Market Dynamics and Financial Trajectory

Last updated: July 4, 2025

Introduction

Telmisartan, a cornerstone angiotensin II receptor blocker (ARB), has transformed hypertension management since its approval in the late 1990s. As global health challenges like cardiovascular diseases escalate, this drug's role in stabilizing blood pressure for millions underscores its commercial significance. For business professionals, understanding telmisartan's market dynamics and financial path offers critical insights into pharmaceutical trends, patent cliffs, and revenue resilience amid generics competition. This analysis delves into current market forces, financial performance, and future projections, drawing on key industry data to inform strategic decisions.

Overview of Telmisartan

Telmisartan operates by blocking angiotensin II receptors, effectively lowering blood pressure and reducing risks of strokes and heart attacks. Originally developed by Boehringer Ingelheim, it gained FDA approval in 1998 and quickly became a preferred treatment due to its long half-life and cardiovascular benefits. The drug's formulation extends to combination therapies, such as with hydrochlorothiazide, enhancing its appeal in a crowded ARB market.

In 2023, telmisartan captured a notable share of the global hypertension market, valued at over $20 billion annually. Its efficacy in diverse patient populations, including those with diabetes, drives demand, particularly in emerging economies where hypertension prevalence surges. Manufacturers like Boehringer Ingelheim and generic producers such as Teva Pharmaceuticals now compete fiercely, influenced by pricing pressures and regulatory shifts.

Current Market Dynamics

The telmisartan market thrives on rising hypertension rates, affecting over 1.28 billion people worldwide according to the World Health Organization. This growth propels demand, with the global ARB segment expanding at a compound annual growth rate (CAGR) of 4.5% through 2028. Telmisartan benefits from its established safety profile and generic availability, which broadens access in cost-sensitive regions like Asia-Pacific and Latin America.

Competition intensifies from peers like losartan and valsartan, eroding telmisartan's premium positioning. In the U.S., where generics dominate 90% of prescriptions, pricing has plummeted by 80% since patent expiration in 2014. Regulatory bodies, including the FDA, enforce strict quality controls, impacting supply chains and favoring producers with robust manufacturing capabilities. Boehringer Ingelheim maintains a lead in branded formulations, while Indian firms like Sun Pharma gain traction in low-cost generics.

Emerging dynamics include the shift toward personalized medicine, where telmisartan's role in combination therapies could unlock new segments. For instance, its integration with statins addresses comorbid conditions, potentially boosting market penetration in aging demographics. Geopolitical factors, such as supply chain disruptions from the COVID-19 pandemic, have also influenced distribution, with Asia-Pacific emerging as the fastest-growing region at a 5.8% CAGR.

Financial Performance and Trajectory

Telmisartan's financial story reflects a classic patent lifecycle: rapid growth followed by a generics-driven decline. Peak revenues for the branded version hit $1.5 billion annually in the mid-2000s, according to Boehringer Ingelheim's reports. Post-2014, U.S. sales dropped sharply as generics entered, slashing prices and eroding margins. Global revenues now hover around $800 million, with generics comprising 85% of total sales volume.

Boehringer Ingelheim's financials show resilience through international markets, where branded telmisartan still commands premiums. In Europe, annual sales exceed €300 million, supported by extended patent protections and favorable reimbursement policies. Emerging markets contribute significantly, with revenues growing 6% year-over-year in regions like India and China, driven by increasing healthcare spending.

Profitability faces headwinds from raw material costs and regulatory fees, but strategic partnerships mitigate risks. For example, licensing deals with generic manufacturers have generated steady licensing fees, stabilizing cash flows. Financial projections from IQVIA indicate a modest 3% CAGR for telmisartan revenues through 2027, fueled by volume growth in underserved areas. Investors should note that while overall profitability lags pre-generics levels, niche applications—such as in renal protection—offer upside potential.

Patent Landscape and Generics Impact

Telmisartan's patent landscape exemplifies the pharmaceutical industry's volatility. The original composition-of-matter patent expired in 2014 in the U.S. and 2015 in Europe, triggering a wave of generics that reduced branded market share from 70% to under 15%. Boehringer Ingelheim pursued extensions for specific formulations, securing secondary patents that expire in 2028 for certain combinations.

This patent erosion has reshaped financial trajectories, with generics flooding the market and compressing prices by up to 90%. Litigation, including challenges from firms like Mylan, delayed some entries but ultimately accelerated competition. In response, manufacturers innovate with extended-release versions or fixed-dose combinations, potentially extending revenue streams.

The generics influx benefits patients and payers through cost savings but challenges innovators like Boehringer Ingelheim, who now focus on value-added services like patient support programs. Regulatory agencies, such as the EMA, enforce biosimilar standards that could influence future entries, underscoring the need for ongoing intellectual property strategies.

Future Outlook

Looking ahead, telmisartan's market will evolve with demographic shifts and therapeutic advancements. By 2030, hypertension cases could rise to 1.5 billion, expanding the addressable market. Opportunities lie in emerging economies, where urbanization and lifestyle diseases drive demand, potentially adding $200 million in annual revenues.

Innovation plays a pivotal role; research into telmisartan's cardioprotective effects may lead to new indications, such as in heart failure management. Companies are exploring digital health integrations, like AI-driven adherence tools, to differentiate offerings. However, risks persist, including potential regulatory hurdles for new formulations and supply chain vulnerabilities.

Financially, projections suggest stabilization rather than explosive growth, with a forecasted global market value of $1 billion by 2028. Investors should monitor pipeline developments and geopolitical influences, as trade policies could affect export-dependent producers. Overall, telmisartan's trajectory hinges on adaptability in a generics-saturated environment.

Key Takeaways

• Telmisartan's market growth stems from rising hypertension prevalence, though generics have significantly reduced pricing and branded revenues.
• Financial performance shows a post-patent decline, with opportunities in emerging markets and combination therapies offering revenue recovery.
• Patent expirations highlight the need for innovation to maintain competitiveness amid intense rivalry.
• Regulatory and economic factors will shape future dynamics, making strategic partnerships essential for sustained profitability.
• Business professionals should prioritize data-driven insights into regional trends and intellectual property to navigate risks effectively.

FAQs

1. What factors primarily drive telmisartan's market growth today?
Telmisartan's growth relies on increasing hypertension rates in emerging markets and its use in combination therapies, offsetting declines in mature regions due to generics.

2. How has the patent expiration affected telmisartan's financials?
The 2014 U.S. patent expiry led to an 80% price drop and revenue fall from $1.5 billion to around $800 million annually, though international sales provide some buffer.

3. Who are the key competitors in the telmisartan market?
Major competitors include other ARBs like losartan and valsartan, with generic manufacturers such as Teva and Sun Pharma challenging Boehringer Ingelheim's dominance.

4. What are the projected revenue trends for telmisartan through 2030?
Revenues are expected to grow at a 3% CAGR, reaching approximately $1 billion by 2030, driven by demand in Asia-Pacific and new therapeutic applications.

5. How do regulatory changes impact telmisartan's market dynamics?
Stricter FDA and EMA regulations on generics quality have delayed some entries, allowing branded versions to retain market share in regulated markets like Europe.

Sources

1. Boehringer Ingelheim annual reports, accessed via company website for historical sales data and financial performance metrics.
2. IQVIA Market Prognosis reports, 2023 edition, for global market size, CAGR projections, and regional growth analysis.
3. World Health Organization data on hypertension prevalence, published in their 2023 global health statistics.