MICARDIS HCT Drug Patent Profile

Which patents cover Micardis Hct, and when can generic versions of Micardis Hct launch?

Micardis Hct is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in MICARDIS HCT 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 HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	72
Drug Prices:	Drug price information for MICARDIS HCT
What excipients (inactive ingredients) are in MICARDIS HCT?	MICARDIS HCT excipients list
DailyMed Link:	MICARDIS HCT at DailyMed

See drug prices for MICARDIS HCT

See drug sales revenues for MICARDIS HCT

Recent Clinical Trials for MICARDIS HCT

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

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

See all MICARDIS HCT clinical trials

Pharmacology for MICARDIS HCT

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for MICARDIS HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MICARDIS HCT	Tablets	hydrochlorothiazide; telmisartan	80 mg/12.5 mg and 40 mg/12.5 mg	021162	1	2008-12-31

US Patents and Regulatory Information for MICARDIS HCT

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 HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	AB	RX	Yes	No
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	AB	RX	Yes	Yes

Expired US Patents for MICARDIS HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000

EU/EMA Drug Approvals for MICARDIS HCT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Krka, d.d., Novo mesto	Tolucombi	telmisartan, hydrochlorothiazide	EMEA/H/C/002549 Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	yes	no	no	2013-03-13
Bayer AG	Kinzalkomb	telmisartan, hydrochlorothiazide	EMEA/H/C/000415 Treatment of essential hypertension.Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	no	no	no	2002-04-19
Bayer AG	PritorPlus	telmisartan, hydrochlorothiazide	EMEA/H/C/000414 Treatment of essential hypertension.PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone.PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	no	no	no	2002-04-22
Actavis Group hf	Actelsar HCT	telmisartan, hydrochlorothiazide	EMEA/H/C/002676 Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.	Authorised	yes	no	no	2013-03-13

International Patents for MICARDIS HCT

See the table below for patents covering MICARDIS HCT around the world.

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

Supplementary Protection Certificates for MICARDIS HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C990007	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211
0502314	99C0014	Belgium		PRODUCT NAME: TELMISARTAN REGISTRATION NO/DATE: EU/1/98/089/001 / 19981211
0502314	SPC/GB99/014	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211
0502314	CA 2002 00023	Denmark
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

MICARDIS HCT Market Analysis and Financial Projection Experimental

Telmisartan Market Dynamics and Financial Trajectory: Insights into MICARDIS HCT

Introduction to MICARDIS HCT

MICARDIS HCT is a combination medication consisting of telmisartan, an angiotensin II antagonist, and hydrochlorothiazide, a diuretic, used primarily to treat high blood pressure (hypertension)[2].

Global Telmisartan Market Overview

The global telmisartan market, which includes MICARDIS HCT, has been experiencing significant growth. In 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 of 2024-2032[1].

Key Drivers of Market Growth

Several factors are driving the growth of the telmisartan market:

Increasing Prevalence of Hypertension

The rise in hypertension cases globally is a major driver. For instance, in the United States, approximately 75 million people have high blood pressure, leading to a surge in demand for antihypertensive medications like telmisartan[1].

Aging Population and Sedentary Lifestyle

The increasing geriatric population and the prevalence of sedentary lifestyles are significant contributors to the market growth. Older adults are more susceptible to cardiovascular diseases, which in turn increases the demand for telmisartan[1][4].

Government Initiatives and Awareness

Government and health organizations' initiatives to raise awareness about hypertension and cardiovascular diseases also fuel market growth. Campaigns such as ‘May Measurement Month & World Hypertension Day’ have been instrumental in increasing awareness and driving demand for telmisartan[4].

Generic Drug Approvals

The approval of abbreviated new drug applications (ANDA) for generic telmisartan tablets has expanded the market. Generic entries have significantly reduced costs for consumers, leading to increased adoption and higher consumer welfare[3][4].

Distribution Channels

The market is segmented by distribution channels, with hospital pharmacies being the largest segment. This segment is expected to generate USD 2,427.30 million, growing at a CAGR of 3.5% during the forecast period. Hospital pharmacies are crucial due to the specialized healthcare professionals and the structure of hospital pharmacies in emerging economies like China and India[1][4].

Online Pharmacies

Online pharmacies are expected to exhibit the highest growth rate due to increased awareness, preference for online purchasing, and the convenience offered by online platforms. This segment is driven by factors such as ease of access, lower expenses, and the ability to compare prices and read patient reviews[4].

Regional Market Dynamics

The telmisartan market is geographically segmented, with North America and Asia-Pacific being key regions.

North America

North America is expected to be the highest shareholder, growing at a CAGR of 3.4% during the forecast period. The dominance of this region is attributed to the high prevalence of hypertension, advanced healthcare facilities, and a well-developed network of hospital and online pharmacies[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 large patient populations, are driving this growth. Increased healthcare expenditures, awareness campaigns, and the focus of leading manufacturers on expanding their presence in this region are key factors[1][4].

Challenges and Opportunities

Despite the growth, the market faces some challenges:

Medication Shortages

Drug shortages are expected to hinder the market expansion of telmisartan. These shortages can disrupt supply chains and impact patient access to necessary medications[1][4].

Research and Development

On the other hand, an increase in telmisartan-related research in emerging nations presents attractive opportunities. This research can lead to new formulations, better treatment options, and expanded market reach[1].

Financial Impact and Consumer Welfare

The entry of generic telmisartan has significantly impacted consumer welfare. Studies have shown that generic entry has resulted in substantial gains for consumers, estimated at $92 billion in the hypertension market between certain periods. This translates to approximately $133 per representative customer, highlighting the financial benefits of generic competition[3].

Healthcare Spending and Economic Impact

The growth in healthcare spending also plays a crucial role. In the U.S., the National Health Expenditure (NHE) is projected to grow, reflecting increased demand for health services and pharmaceuticals. This rise in healthcare spending further fuels the demand for medications like telmisartan[1].

Pharmacological and Clinical Aspects

MICARDIS HCT, as a combination therapy, offers effective blood pressure management. However, it is important to note the potential risks, especially during pregnancy. The use of drugs affecting the renin-angiotensin system during the second and third trimesters can lead to significant fetal and neonatal morbidity and mortality[2].

"Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death." - DailyMed[2]

Key Takeaways

• The global telmisartan market is projected to grow from USD 3,567.30 million in 2023 to USD 4,661.27 million by 2032.
• Hypertension is the primary indication driving market growth.
• North America is the largest market, while Asia-Pacific is the fastest-growing region.
• Hospital pharmacies are the major distribution channel, with online pharmacies showing the highest growth rate.
• Generic drug approvals and increased awareness campaigns are significant drivers.
• Medication shortages and pregnancy-related risks are key challenges.

Frequently Asked Questions (FAQs)

1. What is the primary indication for telmisartan medications like MICARDIS HCT?

The primary indication for telmisartan medications like MICARDIS HCT is the treatment of high blood pressure (hypertension).

2. Which region is expected to be the largest shareholder in the telmisartan market?

North America is expected to be the largest shareholder in the telmisartan market during the forecast period.

3. What are the key drivers of the telmisartan market growth?

Key drivers include the increasing prevalence of hypertension, aging population, sedentary lifestyle, government initiatives, and the approval of generic telmisartan tablets.

4. How do generic drug approvals impact the telmisartan market?

Generic drug approvals significantly reduce costs for consumers, leading to increased adoption and higher consumer welfare, estimated at $92 billion in the hypertension market.

5. What are the potential risks associated with the use of MICARDIS HCT during pregnancy?

The use of MICARDIS HCT during the second and third trimesters of pregnancy can lead to reduced fetal renal function, increased fetal and neonatal morbidity, and death.

Sources:

1. Straits Research - Telmisartan Market Size, Share and Forecast to 2030
2. DailyMed - MICARDIS HCT - telmisartan and hydrochlorothiazide tablet
3. National Bureau of Economic Research - Regulation and Welfare: Evidence from Paragraph IV Generic Entry
4. Allied Market Research - Telmisartan Market Size, Share, Growth & Trends Report, 2027