HYDROCHLOROTHIAZIDE Drug Patent Profile

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

Hydrochlorothiazide is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Norvium Bioscience, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, Oxford Pharms, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Alkem Labs Ltd, and Pharmeral. and is included in one hundred and eleven NDAs.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	48
NDAs:	111
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	383
Patent Applications:	3,825
Drug Prices:	Drug price information for HYDROCHLOROTHIAZIDE
Drug Sales Revenues:	Drug sales revenues for HYDROCHLOROTHIAZIDE
What excipients (inactive ingredients) are in HYDROCHLOROTHIAZIDE?	HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	HYDROCHLOROTHIAZIDE at DailyMed

See drug prices for HYDROCHLOROTHIAZIDE

See drug sales revenues for HYDROCHLOROTHIAZIDE

Recent Clinical Trials for HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 2
University of Bern	Phase 2
University Medical Center Groningen	Phase 3

See all HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for HYDROCHLOROTHIAZIDE

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	040735-002	Jan 23, 2007		DISCN	No	No
Vangard	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	087610-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Heritage	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	085182-003	May 2, 2023	AB	RX	No	No
Aurolife Pharma Llc	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	085219-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Inds Inc	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	040810-001	Mar 27, 2007		DISCN	No	No
Watson Labs Teva	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	083232-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Inwood Labs	HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	084776-001	Approved Prior to Jan 1, 1982		DISCN	No	No

HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydrochlorothiazide

Introduction to Hydrochlorothiazide

Hydrochlorothiazide (HCTZ) is a thiazide diuretic widely used in the treatment of hypertension and edema. It works by increasing urine production, which helps in reducing blood pressure and alleviating fluid retention.

Market Growth Drivers

Increasing Prevalence of Hypertension

The global hydrochlorothiazide market is significantly driven by the increasing prevalence of hypertension. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[1].

Geriatric Population Growth

The rise in the geriatric population is another key factor boosting the market growth. Older adults are more prone to hypertension and other cardiovascular diseases, leading to an increased demand for antihypertensive medications like hydrochlorothiazide[1].

FDA Approvals and New Product Launches

Recent FDA approvals and new product launches have also contributed to the market's growth. For instance, in August 2020, Schein launched a generic version of hydrochlorothiazide/triamterene, which was manufactured by Bolar Pharmaceutical and distributed by Schein[1].

Healthcare Expenditure and R&D Activities

Increased healthcare expenditure and robust research and development activities by pharmaceutical companies are further propelling the market. The launch of novel drugs and the ongoing development of new treatments for hypertension and related conditions are key drivers[1].

Market Trends

New Product Launches

The market has seen several significant product launches in recent years. For example, Beximco Pharmaceuticals Ltd. launched Telma Plus in 2018, which combines hydrochlorothiazide with telmisartan, an angiotensin II antagonist. Such combinations enhance the efficacy of treatment and attract more patients[1].

Generic Versions

Hydrochlorothiazide is available only as a generic drug, which tends to be more cost-effective than brand-name medications. This has made it more accessible to a wider population, contributing to its market growth[2].

Challenges and Restraints

Side Effects

Despite its widespread use, hydrochlorothiazide is associated with several side effects, such as electrolyte imbalance, increased urination, and potential kidney problems. These side effects can hamper the market growth as patients and healthcare providers may opt for alternative treatments with fewer adverse effects[1].

Financial Trajectory

Cost and Insurance Coverage

The cost of hydrochlorothiazide can vary based on factors such as treatment plans, insurance coverage, and the pharmacy used. However, since it is available as a generic, it generally costs less than brand-name drugs. Insurance coverage can significantly reduce the cost, but prior authorization may be required in some cases[2].

Long-Term Cost Reduction

Patients can lower the long-term costs of hydrochlorothiazide by opting for a 90-day supply or using mail-order pharmacies. These strategies can reduce the number of trips to the pharmacy and potentially lower the overall cost[2].

Market Size and Forecast

The global hydrochlorothiazide market is expected to witness significant growth from 2021 to 2030. The market size is driven by the increasing prevalence of hypertension, the growing geriatric population, and the rise in FDA approvals for new drugs. The market is also influenced by the ongoing COVID-19 pandemic, which has highlighted the importance of robust healthcare systems and the demand for effective antihypertensive medications[1].

Key Market Players

The hydrochlorothiazide market is competitive, with several key players such as Beijing Second Pharmaceutical, Par Pharmaceutical, Zhejiang Huahai Pharmaceutical, Novartis, Teva, and others. These companies are involved in the manufacture and distribution of hydrochlorothiazide and its combination drugs[1].

Regional Analysis

The market for hydrochlorothiazide is global, with different regions contributing to its growth. Economically developing nations are expected to see a significant rise in the prevalence of hypertension, thereby driving the demand for hydrochlorothiazide in these regions[1].

Competitive Analysis

The competitive landscape of the hydrochlorothiazide market is characterized by high promotional expenditures, particularly among non-leading firms. This is evident from studies that show non-leading firms in the oral diuretics market spend a higher percentage of their sales on promotion compared to leading firms[3].

Porter’s Five Forces Analysis

Porter’s five forces analysis highlights the competitive intensity and the bargaining power of buyers and suppliers in the market. The analysis indicates that the market is moderately competitive, with buyers having some bargaining power due to the availability of generic options[1].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the hydrochlorothiazide market. The increased demand for antihypertensive medications and the challenges in the supply chain have presented both opportunities and challenges for manufacturers[1].

"Pharmaceutical and biotech companies together with governments around the globe are working to address the COVID-19 outbreak, from supporting the development of vaccines to planning for medicine supply chain challenges."[1]

Future Projections

The future of the hydrochlorothiazide market looks promising, driven by the increasing prevalence of hypertension and the growing need for effective antihypertensive treatments. The market is expected to continue growing as new products are launched and healthcare expenditure increases globally[1].

Key Takeaways

• The global hydrochlorothiazide market is driven by the increasing prevalence of hypertension and the growing geriatric population.
• New product launches and FDA approvals are significant growth drivers.
• The market is challenged by side effects associated with hydrochlorothiazide.
• Generic versions of the drug are cost-effective and widely available.
• The COVID-19 pandemic has highlighted the importance of robust healthcare systems and the demand for effective antihypertensive medications.

Frequently Asked Questions (FAQs)

What are the primary uses of hydrochlorothiazide?

Hydrochlorothiazide is primarily used to treat hypertension (high blood pressure) and edema (fluid retention).

How does hydrochlorothiazide work?

Hydrochlorothiazide works by increasing urine production, which helps reduce blood pressure and alleviate fluid retention.

What are the common side effects of hydrochlorothiazide?

Common side effects include electrolyte imbalance, increased urination, and potential kidney problems.

Is hydrochlorothiazide available as a brand-name drug?

No, hydrochlorothiazide is available only as a generic drug, which tends to be more cost-effective than brand-name medications.

How can the cost of hydrochlorothiazide be reduced?

The cost can be reduced by opting for a 90-day supply, using mail-order pharmacies, or taking advantage of insurance coverage and financial assistance programs.

Cited Sources:

1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)[1]
2. Medical News Today: Hydrochlorothiazide cost 2024: Coupons and more[2]
3. Federal Trade Commission: Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets[3]
4. Cognitive Market Research: Global Triamterene Hydrochlorothiazide Market Report 2024 Edition[4]
5. NCBI Bookshelf: Chlorthalidone - StatPearls[5]