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-nine 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:	29
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	277
Patent Applications:	7,882
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
National Institute for Health Research, United Kingdom	PHASE3
John Black Charitable Foundation	PHASE3
Parkinson's UK	PHASE3

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
Sandoz	TELMISARTAN	telmisartan	TABLET;ORAL	203867-003	Nov 3, 2014	AB	RX	No	No
Zydus Pharms	TELMISARTAN	telmisartan	TABLET;ORAL	203325-001	Aug 26, 2014	AB	RX	No	No
Prinston Inc	TELMISARTAN	telmisartan	TABLET;ORAL	207882-003	May 3, 2017	AB	RX	No	No
Mankind Pharma	TELMISARTAN	telmisartan	TABLET;ORAL	218157-003	Oct 15, 2024	AB	RX	No	No
Jubilant Generics	TELMISARTAN	telmisartan	TABLET;ORAL	204164-003	Aug 22, 2016		DISCN	No	No
Sandoz	TELMISARTAN	telmisartan	TABLET;ORAL	203867-002	Nov 3, 2014	AB	RX	No	No
Jubilant Generics	TELMISARTAN	telmisartan	TABLET;ORAL	204164-001	Aug 22, 2016		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	5,591,762
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	7,998,953
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	6,358,986
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	020850-003	Apr 4, 2000	6,358,986

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/000209HypertensionTreatment 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/001196HypertensionTreatment 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/002511Treatment of essential hypertension in adults.	Authorised	yes	no	no	2011-10-03
Teva B.V.	Telmisartan Teva	telmisartan	EMEA/H/C/001146Treatment of essential hypertension in adults	Withdrawn	yes	no	no	2010-01-25
Actavis Group PTC ehf	Telmisartan Actavis	telmisartan	EMEA/H/C/001168HypertensionTreatment 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/000211HypertensionTreatment 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
Bayer AG	Pritor	telmisartan	EMEA/H/C/000210HypertensionTreatment 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	1998-12-11

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Telmisartan

Last updated: July 27, 2025

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Introduction

Telmisartan, marketed predominantly under the brand name Micardis by Boehringer Ingelheim, is an angiotensin II receptor blocker (ARB) primarily prescribed for hypertension and cardiovascular risk management. Since its approval, telmisartan has established itself as a significant player within the ARB segment, driven by its unique pharmacological properties and expanding therapeutic indications. This report analyzes the current market landscape, drivers and restraints influencing its growth, and forecasts its financial trajectory over the upcoming years.

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Pharmacological Profile and Therapeutic Indications

Telmisartan functions by selectively blocking angiotensin II type 1 (AT1) receptors, leading to vasodilation and blood pressure reduction. Its high lipophilicity confers prolonged plasma half-life, enabling once-daily dosing and improving patient adherence. Besides hypertension, telmisartan has received approval for cardiovascular event risk reduction in high-risk patients and is being investigated for additional indications such as metabolic syndrome and diabetic nephropathy. The drug’s favorable safety profile has also contributed to its widespread acceptance.

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Market Landscape and Competitive Positioning

The global ARB market, which exceeds USD 25 billion as of 2022, features prominent drugs like losartan, valsartan, irbesartan, and telmisartan. Telmisartan's market share remains robust, particularly in regions favoring once-daily dosing and benefits in metabolic profiles. Its differentiation lies in its long half-life and potential benefits in metabolic parameters, positioning it favorably against competitors.

Major manufacturers like Boehringer Ingelheim, along with generic producers, dictate market dynamics through patent protections and subsequent off-patent generic availability. The expiration of telmisartan's primary patent in most regions has facilitated generics' entry, significantly impacting sales and pricing strategies.

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Market Dynamics Influencing Telmisartan

1. Patent Expiry and Generic Competition

   The patent expiry in key markets, including the EU and the US (around 2019-2020), led to increased availability of generics, precipitating a sharp decline in branded sales. Despite this, the marketed formulations continue to see demand due to physician familiarity and perceived clinical efficacy.

2. Regulatory Approvals and Expanded Indications

   Regulatory agencies have approved telmisartan for additional uses, particularly for cardiovascular risk reduction. Ongoing clinical trials exploring benefits in metabolic syndrome and diabetic nephropathy could further expand its prescription base, influencing long-term growth.

3. Pricing Strategies and Reimbursement Policies

   Generic entry has drastically reduced prices, making telmisartan a cost-effective option. Reimbursement policies in major markets favor first-line antihypertensives, bolstering sales volume, though price pressures persist.

4. Emerging Market Penetration

   Countries in Asia, Latin America, and Africa exhibit increasing hypertension prevalence and income growth, creating expanding markets for telmisartan. Local manufacturers amplify competition but also pose opportunities for market share growth through affordable pricing strategies.

5. Physician Prescribing Trends

   The preference for ARBs over other antihypertensives due to superior tolerability sustains demand. However, the increasing preference for newer agents with additional benefits (e.g., ARNI drugs) may influence prescription patterns.

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Financial Trajectory and Forecasting

1. Historical Performance

   Prior to patent expiration, telmisartan's global sales peaked around USD 3.5 billion annually, driven primarily by the branded formulation. Post-patent expiry, sales declined sharply, with generics capturing a significant market share. Boehringer Ingelheim's revenues from telmisartan in 2018 (~USD 2.8 billion) saw a decline of approximately 35% by 2022, aligning with the generic market saturation.

2. Impact of Generic Competition

   Generics, now accounting for over 80% of the market share, have reduced average prices by up to 70%. As a result, the overall market volume remains stable or slightly increased due to the rising prevalence of hypertension, but revenues for original branded versions decline.

3. Forecasting Future Trends

   • Near-term (2023-2025): The market volume for telmisartan is projected to stabilize or modestly grow, driven by increased hypertension awareness and the expanded use in metabolic and nephrological conditions. However, revenue growth for branded formulations remains limited unless differentiated offerings or combination therapies emerge.

   • Medium to Long-term (2026-2030): Growth prospects hinge on clinical validation of new indications, strategic partnerships to develop combination drugs, and potential repositioning in non-hypertensive cardiovascular conditions. Nonetheless, the core market is expected to be mature, facing stiff price competition from generics.

   • Potential for Biosimilars or Next-Generation ARBs: The advent of biosimilar or innovative ARBs with enhanced efficacy or safety profiles could alter the competitive landscape, possibly revitalizing demand for telmisartan or its successors.

4. Strategic Opportunities

   • Market Expansion: Targeting emerging markets with increasing hypertension prevalence.
   • Value-added Formulations: Developing combination therapies or novel delivery mechanisms.
   • Differentiated Marketing: Emphasizing telmisartan's unique pharmacology and benefits in metabolic parameters.

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Regulatory and Patent Considerations

Patent protections for telmisartan have largely expired worldwide. Boehringer Ingelheim's strategy has focused on maintaining market share through pipeline development, such as fixed-dose combinations, and expanding clinical indications. Regulatory challenges in certain markets—especially regarding off-label uses—may influence future sales trajectories.

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Conclusion and Outlook

The telmisartan market exemplifies the lifecycle dynamics prevalent in blockbuster pharmaceuticals. After the initial high-revenue phase cultivated during patent exclusivity, the market transitioned into a generic-dominated landscape with constrained revenue growth. Moving forward, opportunities for growth will depend on clinical expansion, strategic innovation, and geographic penetration, primarily within emerging markets. Policymakers, pharma companies, and healthcare providers must adapt to evolving competition, driven by pricing pressures and incremental therapeutic innovations.

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Key Takeaways

• Patent expiry triggered a shift from branded to generic dominance, significantly impacting revenues.
• Long-term growth depends on expanding indications, combination formulations, and emerging markets.
• Pricing strategies and reimbursement policies are critical to sustaining profitability amid intense competition.
• Clinical validation of new therapeutic uses can create differentiation and open new revenue streams.
• Emerging markets offer substantial growth potential for telmisartan, driven by demographic and epidemiological trends.

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FAQs

1. What are the primary factors influencing telmisartan's market share post-patent expiry?
   Generic availability, pricing pressures, physician prescribing habits, and expansion into new indications significantly influence its market share after patent expiration.

2. Are there any notable clinical developments that could revive telmisartan sales?
   Ongoing research into its benefits beyond hypertension, such as in metabolic syndrome and diabetic nephropathy, could support increased indications and sales.

3. How does telmisartan compare to other ARBs in terms of efficacy and safety?
   Telmisartan's long half-life and favorable metabolic profile differentiate it favorably, though efficacy is broadly comparable among ARBs. Safety profiles are similar, with tolerability being a key advantage.

4. What strategies are pharmaceutical companies adopting to sustain revenues for telmisartan?
   Companies are focusing on developing fixed-dose combinations, expanding indications, targeting emerging markets, and investing in clinical research for new therapeutic uses.

5. What is the outlook for telmisartan in the global hypertension market?
   The outlook suggests maturation with limited revenue growth in developed markets but sustained demand through volume increases and market expansion in emerging regions.

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References

[1] Market research reports on ARB global market size and trends.
[2] Boehringer Ingelheim annual financial disclosures.
[3] Regulatory agency approvals and clinical trial databases.
[4] Industry analyses on patent expirations and generic market impacts.