Hydrochlorothiazide - Generic Drug Details

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

Hydrochlorothiazide is the generic ingredient in sixty-three branded drugs 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, Teva Branded Pharm, Morton Grove, Roxane, Novartis, Halsey, 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, Merck, Abbvie, Sanofi Aventis Us, Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Sandoz, Watson Labs Inc, Schering, Glaxosmithkline, Aurobindo, Corepharma, Epic Pharma Llc, Invagen Pharms, Lupin, Sun Pharm Inds Ltd, Almatica, Organon, Granules, Teva Pharms, Torrent Pharms, Zydus Pharms Usa Inc, Parke Davis, Purepac Pharm, Rising, Strides Pharma, Concordia, Validus Pharms, Sun Pharm Inds, Glenmark Pharms, Ucb Inc, Cosette, Alkem Labs Ltd, Natco Pharma Usa, Teva Pharms Usa, Torrent, Umedica, Zydus Pharms, Wyeth Ayerst, Wyeth Pharms Inc, Duramed Pharms Barr, Ani Pharms, Pfizer Pharms, Pharmeral, Pfizer, Mutual Pharm, Ivax Pharms, Lederle, Upsher Smith, Boehringer Ingelheim, Glenmark Pharms Ltd, Natco, Glaxosmithkline Llc, Cadila, Vitarine, Aurobindo Pharma Usa, Am Therap, Pliva, Quantum Pharmics, Rubicon, Amneal Pharms, Mylan Pharms Inc, and Zydus Lifesciences, and is included in three hundred and thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide. Forty-five suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for hydrochlorothiazide

US Patents:	0
Tradenames:	63
Applicants:	118
NDAs:	333
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	383
Patent Applications:	6,865
Drug Prices:	Drug price trends 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

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE

Applicant	Application No.	Strength	Dosage Form
		12.5MG;300MG	TABLET;ORAL
		12.5MG;150MG	TABLET;ORAL
		25MG;300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Ani Pharms	PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; propranolol hydrochloride	TABLET;ORAL	070705-002	Oct 1, 1986		DISCN	No	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No
Watson Labs	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	073449-001	Sep 23, 1993	AB	RX	No	No
Sun Pharm Inds Ltd	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076007-003	Jul 1, 2002	AB	RX	No	No
Novartis	SERPASIL-ESIDRIX #1	hydrochlorothiazide; reserpine	TABLET;ORAL	011878-003	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]