TELMISARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile

When do Telmisartan And Hydrochlorothiazide patents expire, and when can generic versions of Telmisartan And Hydrochlorothiazide launch?

Telmisartan And Hydrochlorothiazide is a drug marketed by Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Natco, Prinston Inc, Torrent, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE 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 TELMISARTAN AND HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	47
What excipients (inactive ingredients) are in TELMISARTAN AND HYDROCHLOROTHIAZIDE?	TELMISARTAN AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	TELMISARTAN AND HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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 TELMISARTAN AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for TELMISARTAN AND HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	203010-001	Feb 25, 2014	AB	RX	No	No
Natco	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	091648-003	Feb 25, 2014		DISCN	No	No
Torrent	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	201192-003	Feb 25, 2014		DISCN	No	No
Glenmark Pharms Ltd	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	202544-001	Mar 4, 2019	AB	RX	No	No

EU/EMA Drug Approvals for TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

TELMISARTAN AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Telmisartan and Hydrochlorothiazide Market Dynamics and Financial Trajectory

Market Overview

The global market for telmisartan and hydrochlorothiazide, a combination of antihypertensive agents, is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

As of 2023, the global telmisartan market was valued at USD 3,567.30 million. It 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][4].

Key Drivers

Increasing Prevalence of Hypertension

The rise in hypertension cases globally is a major driver for the telmisartan and hydrochlorothiazide market. Hypertension is a significant health concern, and the increasing awareness about its treatment and management is fueling the demand for these medications[1][3][4].

Aging Population and Sedentary Lifestyle

The growing geriatric population and the prevalence of sedentary lifestyles are contributing to the increased incidence of hypertension and other cardiovascular diseases. This demographic shift is expected to continue driving the market growth[1][3][4].

Government Initiatives and Awareness

Government and health organizations' initiatives to raise awareness about hypertension and its management are also driving the market. For example, campaigns like ‘May Measurement Month & World Hypertension Day’ by organizations such as the Argentinian Society of Hypertension (SAHA) are making a significant impact[4].

Approval of Generic Versions

The approval of abbreviated new drug applications (ANDA) for generic telmisartan tablets is another factor contributing to market growth. This has increased the availability and affordability of the drug, especially in emerging economies[1][4].

Distribution Channels

Hospital Pharmacies

The hospital pharmacies segment is expected to be a major shareholder in the global telmisartan market. This is due to the increase in the number of hospitalized hypertension patients, the growth in the number of hospital pharmacies worldwide, and improvements in the structure of hospital pharmacies in emerging countries like China and India[1][4].

Online Pharmacies

Online pharmacies are also expected to exhibit high growth rates during the forecast period. The convenience, lower costs, and ease of access to patient reviews and price comparisons offered by online pharmacies are driving this segment's growth[4].

Regional Analysis

North America

North America is anticipated to be the highest shareholder in the telmisartan market during the forecast period, growing at a CAGR of 3.4%. The region's dominance is attributed to the high number of hypertension patients, advanced healthcare facilities, and the presence of a large number 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. This growth is driven by the densely populated countries like China and India, increased healthcare expenditures, and rising awareness about the use of telmisartan medications[1][4].

Combination Therapy

Telmisartan is often used in combination with hydrochlorothiazide (HCTZ), a thiazide diuretic. This combination has been shown to be highly effective in reducing both systolic and diastolic blood pressure in patients with hypertension. Clinical trials have demonstrated that the combination of telmisartan and HCTZ results in significant reductions in blood pressure compared to monotherapy with either drug[2][5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the telmisartan and hydrochlorothiazide market. While the pandemic increased the focus on health and wellness, leading to higher demand for hypertension treatments, it also caused disruptions in the pharmaceutical supply chain and healthcare access challenges. These factors have affected market dynamics but have not significantly hindered long-term growth[3].

Competitive Analysis

The telmisartan market is competitive, with several key players actively involved in research, new drug launches, and expanding their geographic presence, especially in emerging economies. The focus on increasing their presence in Asia-Pacific countries is expected to drive market expansion[1][4].

Financial Trajectory

The financial trajectory of the telmisartan market is positive, driven by the increasing demand for antihypertensive medications. Here are some key financial statistics:

• Market Size in 2023: USD 3,567.30 million[1].
• Projected Market Size by 2032: USD 4,661.27 million[1].
• CAGR: 3.4% from 2024 to 2032[1][4].
• Hospital Pharmacies Segment: Expected to generate USD 2,427.30 million, growing at a CAGR of 3.5% during the forecast period[1].

Challenges and Opportunities

Challenges

• Medication Shortages: Drug shortages are expected to hinder the market expansion of telmisartan[1][4].
• Healthcare Costs: Substantial increases in healthcare costs can impact the expansion of the pharmaceutical industry[1].

Opportunities

• Emerging Markets: A rise in telmisartan-related research in emerging nations is anticipated to create attractive prospects during the forecast period[1].
• Online Pharmacies: The growing preference for online purchasing of drugs offers significant opportunities for market growth[4].

Key Takeaways

• The global telmisartan market is driven by the increasing prevalence of hypertension, an aging population, and sedentary lifestyles.
• The combination of telmisartan and hydrochlorothiazide is highly effective in managing hypertension.
• North America and the Asia-Pacific region are key markets, with the latter expected to grow at a higher CAGR.
• Hospital pharmacies and online pharmacies are significant distribution channels.
• Despite challenges like medication shortages, the market is expected to grow steadily.

FAQs

What is the current market size of the global telmisartan market?

The global telmisartan market was valued at USD 3,567.30 million in 2023[1].

What is the projected growth rate of the telmisartan market from 2024 to 2032?

The telmisartan market is expected to grow at a CAGR of 3.4% from 2024 to 2032[1][4].

Which region is expected to exhibit the highest growth rate in the telmisartan market?

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

What are the key drivers of the telmisartan market?

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

How does the combination of telmisartan and hydrochlorothiazide impact blood pressure?

The combination of telmisartan and hydrochlorothiazide results in significant reductions in both systolic and diastolic blood pressure, making it a highly effective treatment for hypertension[2][5].

Sources

1. Straits Research: Telmisartan Market Size, Share and Forecast to 2030
2. PubMed: Telmisartan/hydrochlorothiazide: in the treatment of essential hypertension
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 / 12.5 mg[5]