micardis Drug Patent Profile

When do Micardis patents expire, and when can generic versions of Micardis launch?

Micardis is a drug marketed by Boehringer Ingelheim and is included in two NDAs.

The generic ingredient in MICARDIS is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for micardis

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	72
Patent Applications:	4,398
Drug Prices:	Drug price information for micardis
Drug Sales Revenues:	Drug sales revenues for micardis
What excipients (inactive ingredients) are in micardis?	micardis excipients list
DailyMed Link:	micardis at DailyMed

See drug prices for micardis

See drug sales revenues for micardis

Recent Clinical Trials for micardis

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

Sponsor	Phase
Tyler J Curiel	Early Phase 1
Queens Medical Center	Phase 2
University of Hawaii	Phase 2

See all micardis clinical trials

Pharmacology for micardis

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

Paragraph IV (Patent) Challenges for MICARDIS

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 micardis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	AB	RX	Yes	Yes
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	AB	RX	Yes	Yes
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	AB	RX	Yes	No

Expired US Patents for micardis

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
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-001	Nov 10, 1998
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000

EU/EMA Drug Approvals for micardis

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
Bayer AG	Pritor	telmisartan	EMEA/H/C/000210 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	1998-12-11

International Patents for micardis

See the table below for patents covering micardis around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	660209
Poland	340838
Mexico	9302034	BENCIDAZOLES, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS Y PROCEDIMIENTOS PARA SU PREPARACION.
Czech Republic	9203944
Hungary	0900792
Finland	920486
Germany	59209330	Benzimidazole, diese Verbindungen enthaltende Arzneimittel und Verfahren zu ihrer Herstellung

Supplementary Protection Certificates for micardis

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0502314	23/1999	Austria		PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211
0502314	99C0014	Belgium		PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	1190006-5.L	Sweden		PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007

Micardis Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Micardis (Telmisartan)

Introduction

Micardis, known generically as telmisartan, is a non-peptide angiotensin receptor blocker (ARB) primarily used to treat hypertension and reduce cardiovascular risk. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Global Market Size and Forecast

The global telmisartan market has been experiencing significant growth. As of 2023, the market size 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 from 2024 to 2032[1].

Key Market Drivers

Rising Prevalence of Hypertension

The increasing rates of high blood pressure, particularly among the aging population, are a major driver for the demand of telmisartan. Hypertension is anticipated to command the largest market share due to its growing prevalence[1][3].

Growing Geriatric Population

As the global population ages, cardiovascular diseases and hypertension become more common, boosting the demand for telmisartan. The elderly population is more prone to hypertension, which fuels the market growth[3].

Generic Drug Expansion

The approval of abbreviated new drug applications (ANDAs) for generic telmisartan tablets has significantly expanded the market. Generic versions of telmisartan are more affordable, making the medication accessible to a broader population[1][3].

Online Pharmacies and Healthcare Expenditure

The rise of online pharmacies and increased healthcare expenditures globally have also contributed to the market growth. Online pharmacies offer convenience and price comparison options, making it easier for patients to purchase telmisartan[1][3].

Regional Analysis

North America

North America is expected to be the highest shareholder in the telmisartan market, growing at a CAGR of 3.4% during the forecast period. This dominance is attributed to the high number of hypertension patients, advanced healthcare facilities, and a well-developed network of hospital and online pharmacies in the region[1].

Asia-Pacific

The Asia-Pacific region is expected to grow at a higher CAGR of 5.5% during the forecast period. Countries like China and India, with their large and densely populated areas, contribute significantly to the market expansion. Increased healthcare expenditures and rising awareness of cardiovascular diseases in this region also fuel the market growth[1].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies remain the dominant distribution channel, benefiting from the large number of hospitalized hypertension patients. These pharmacies ensure a steady supply of telmisartan to patients who require immediate and continuous treatment[3].

Online Pharmacies

Online pharmacies are expected to grow rapidly due to the convenience, price comparison options, and increased online drug purchasing trends. This shift is particularly beneficial for patients who prefer the ease of online shopping and home delivery of their medications[3].

Competitive Landscape

The telmisartan market is competitive, with several key players actively involved in research, development, and market expansion. Companies are focusing on increasing their geographic presence, especially in emerging markets in the Asia-Pacific region, to capitalize on the significant growth potential[1][3].

Financial Trajectory

Revenue Growth

The revenue from telmisartan is expected to increase substantially over the forecast period. The market's growth is supported by increasing healthcare spending, which is reflected in the rising National Health Expenditure (NHE) in countries like the U.S., projected to reach USD 4.4 trillion in 2022 and USD 4.6 trillion in 2023[1].

Impact of Generic Approvals

The approval of generic versions of telmisartan has a dual impact on the market. While it increases accessibility and affordability, it also poses a challenge to the revenue of branded versions. However, the overall market size is expected to grow due to the increased demand driven by generic expansions[1][3].

Challenges and Opportunities

Despite the positive outlook, the telmisartan market faces challenges such as medication shortages, which can hinder market expansion. However, the rise in telmisartan-related research in emerging nations is anticipated to create attractive prospects during the forecast period[1].

Side Effects and Safety Profile

Telmisartan, like any medication, has its side effects, including cough, dizziness, sinus pain, and lightheadedness. These side effects are crucial for patients and healthcare providers to consider when prescribing or taking the medication[5].

Key Takeaways

• The global telmisartan market is projected to grow at a CAGR of 3.4% from 2024 to 2032.
• Rising hypertension rates and an aging population are key drivers of the market.
• Generic drug expansions and online pharmacies are significant contributors to market growth.
• North America and the Asia-Pacific region are key markets, with the latter expected to grow at a higher CAGR.
• Hospital and online pharmacies are the primary distribution channels.

FAQs

Q: What is the primary use of telmisartan?

A: Telmisartan is primarily used to treat hypertension and reduce cardiovascular risk.

Q: What is the expected market size of telmisartan by 2032?

A: The global telmisartan market is expected to reach USD 4,661.27 million by 2032.

Q: Which region is expected to grow at a higher CAGR in the telmisartan market?

A: The Asia-Pacific region is expected to grow at a higher CAGR of 5.5% during the forecast period.

Q: What are the main distribution channels for telmisartan?

A: Hospital pharmacies and online pharmacies are the main distribution channels for telmisartan.

Q: What are some of the side effects of telmisartan?

A: Common side effects of telmisartan include cough, dizziness, sinus pain, and lightheadedness.

Sources

1. Straits Research: Telmisartan Market Size, Share and Forecast to 2030
2. Astellas: Financial Results of Astellas for Fiscal Year 2019
3. EIN Presswire: Telmisartan Market Surges Amid Rising Hypertension Rates and Expanding Generic Approvals: Key Drivers and Opportunities
4. Boehringer Ingelheim: 2023 Highlights | Boehringer Ingelheim Annual Report
5. KBV Research: Telmisartan Market Size, Share & Top Market Players, 2026