HYDROCHLOROTHIAZIDE; TELMISARTAN - Generic Drug Details

What are the generic drug sources for hydrochlorothiazide; telmisartan and what is the scope of freedom to operate?

Hydrochlorothiazide; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Natco, Prinston Inc, Torrent, and Zydus Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TELMISARTAN

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	47
Patent Applications:	92
DailyMed Link:	HYDROCHLOROTHIAZIDE; TELMISARTAN at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

Sponsor	Phase
IlDong Pharmaceutical Co Ltd	Phase 1
IlDong Pharmaceutical Co Ltd	Phase 3
The George Institute for Global Health, China	N/A

See all HYDROCHLOROTHIAZIDE; TELMISARTAN clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TELMISARTAN

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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 HYDROCHLOROTHIAZIDE; TELMISARTAN

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 HYDROCHLOROTHIAZIDE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-003	Feb 25, 2014		DISCN	No	No
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-002	Feb 25, 2014		DISCN	No	No
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-001	Feb 25, 2014		DISCN	No	No
Macleods Pharms Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204169-003	Nov 2, 2015		DISCN	No	No
Zydus Pharms	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	204221-003	Aug 15, 2017	AB	RX	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; TELMISARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	5,591,762
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	6,358,986
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	6,358,986
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	5,591,762

EU/EMA Drug Approvals for HYDROCHLOROTHIAZIDE; TELMISARTAN

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

HYDROCHLOROTHIAZIDE; TELMISARTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Telmisartan and Hydrochlorothiazide

Market Overview

The global market for telmisartan, often combined with hydrochlorothiazide (HCTZ), is experiencing significant growth driven by several key factors. Here are the key dynamics and financial projections for this market.

Global Market Size and Growth

The global telmisartan market was valued at USD 3,567.30 million in 2023 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 (2024-2032)[1][4].

Drivers of Market Growth

Increasing Prevalence of Hypertension

The rising prevalence of hypertension globally is a major driver of the telmisartan market. Hypertension is a significant health concern, and the increasing awareness about its treatment and management is fueling the demand for antihypertensive medications like telmisartan[1][3][4].

Aging Population and Sedentary Lifestyle

The aging population and sedentary lifestyles are contributing to the growing demand for telmisartan. As the global population ages, the incidence of chronic diseases such as hypertension, diabetes, and kidney disease increases, driving the market growth[1][3][4].

Government Initiatives and Awareness

Government initiatives and campaigns aimed at raising awareness about hypertension and its management are also driving the market. For example, the Argentinian Society of Hypertension's campaigns like ‘May Measurement Month & World Hypertension Day’ have contributed to increased awareness and treatment seeking[4].

Approval of Generic Versions

The approval of abbreviated new drug applications (ANDA) for generic telmisartan tablets has increased the availability and affordability of the drug, further boosting market growth[1][4].

Regional Market Dynamics

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 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 and increasing healthcare expenditures, are driving this growth. The region's strong development potential, due to the rising prevalence of cardiovascular diseases and the expansion of hospital and online pharmacies, also contributes to the market's expansion[1][4].

Distribution Channels

Hospital Pharmacies

The hospital pharmacies segment is the major shareholder in the global telmisartan market. This is due to the increasing number of hospitalized hypertension patients, the improvement in hospital pharmacy structures in emerging economies, and the fact that telmisartan is a prescription-based medication often prescribed by specialized healthcare professionals in hospitals[1][4].

Online Pharmacies

Online pharmacies are expected to exhibit the highest growth rate during the forecast period. The convenience, lower expenses, and easy access to patient reviews and price comparisons offered by online pharmacies are driving this segment's growth[4].

Combination Therapies

Telmisartan and Hydrochlorothiazide

Combination therapies, particularly telmisartan plus hydrochlorothiazide, have shown significant efficacy in treating mild to moderate hypertension. Studies have demonstrated that once-daily telmisartan 80 mg/HCTZ 12.5 mg is effective and well-tolerated, providing greater antihypertensive efficacy than monotherapy with either agent[2].

Challenges and Opportunities

Medication Shortages

Medication shortages are expected to hinder the market expansion of telmisartan. Disruptions in the pharmaceutical supply chain, especially during the COVID-19 pandemic, have affected market dynamics[1][3].

Research in Emerging Economies

Despite the challenges, the rise in telmisartan-related research in emerging nations is anticipated to create attractive opportunities during the forecast period. This includes increased funding from government and non-government sectors to create awareness about hypertension and cardiovascular diseases[1][4].

Financial Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the telmisartan market. While it increased the focus on health and wellness, prompting individuals to seek treatment for conditions like hypertension, it also caused disruptions in the pharmaceutical supply chain and healthcare access challenges during lockdowns[3].

Key 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 CAGR: 3.4%[1]
• Hospital Pharmacies Segment: Expected to generate USD 2,427.30 million, growing at a CAGR of 3.5%[1]

Pharmacokinetics and Efficacy

Telmisartan has a terminal elimination half-life of approximately 24 hours and shows bi-exponential decay kinetics. When combined with HCTZ, it provides additive antihypertensive efficacy and protects against potassium depletion, a common side effect of thiazide monotherapy[2][5].

Conclusion

The telmisartan market, particularly when combined with hydrochlorothiazide, is poised for significant growth driven by increasing prevalence of hypertension, aging population, sedentary lifestyles, and government initiatives. While challenges such as medication shortages exist, the rise in research and awareness in emerging economies presents lucrative opportunities.

Key Takeaways

• The global telmisartan market is expected to grow at a CAGR of 3.4% from 2024 to 2032.
• North America and Asia-Pacific are key regions driving market growth.
• Hospital pharmacies and online pharmacies are significant distribution channels.
• Combination therapies with HCTZ enhance efficacy and safety.
• Medication shortages and COVID-19 disruptions are challenges, but research in emerging economies offers opportunities.

FAQs

What is the projected global market size for telmisartan by 2032?

The global telmisartan market is projected to reach USD 4,661.27 million by 2032[1].

Which region is expected to grow at the highest CAGR in the telmisartan market?

The Asia-Pacific region is expected to grow at a CAGR of 5.5% during the forecast period[1].

What are the primary drivers of the telmisartan market growth?

The primary drivers include the increasing prevalence of hypertension, aging population, sedentary lifestyles, and government initiatives to raise awareness about hypertension[1][3][4].

How does the combination of telmisartan and hydrochlorothiazide impact treatment efficacy?

The combination of telmisartan and HCTZ provides greater antihypertensive efficacy than monotherapy with either agent and protects against potassium depletion[2].

What are the challenges facing the telmisartan market?

Medication shortages and disruptions in the pharmaceutical supply chain, particularly during the COVID-19 pandemic, are significant challenges[1][3].

Sources

1. Straits Research: Telmisartan Market Size, Share and Forecast to 2030
2. PubMed: Telmisartan plus hydrochlorothiazide versus telmisartan ...
3. OpenPR: Exploring the Global Telmisartan and Hydrochlorothiazide Drug
4. Allied Market Research: Telmisartan Market Size, Share, Growth & Trends Report, 2027
5. FDA: Micardis HCT (telmisartan and hydrochlorothiazide) Tablets, 40 mg ...