MAXZIDE-25 Drug Patent Profile

When do Maxzide-25 patents expire, and what generic alternatives are available?

Maxzide-25 is a drug marketed by Aurobindo Pharma Usa and is included in one NDA.

The generic ingredient in MAXZIDE-25 is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for MAXZIDE-25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	107
What excipients (inactive ingredients) are in MAXZIDE-25?	MAXZIDE-25 excipients list
DailyMed Link:	MAXZIDE-25 at DailyMed

Recent Clinical Trials for MAXZIDE-25

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

Sponsor	Phase
VA Office of Research and Development
US Department of Veterans Affairs

See all MAXZIDE-25 clinical trials

US Patents and Regulatory Information for MAXZIDE-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	AB	RX	Yes	No

Expired US Patents for MAXZIDE-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988

International Patents for MAXZIDE-25

See the table below for patents covering MAXZIDE-25 around the world.

Country	Patent Number	Title	Estimated Expiration
France	2363326
Austria	29663
Philippines	21520	ANTIHYPERTENSIVE DIURETIC COMBINATION AND ASSOCIATED METHOD
Japan	H0231053

Supplementary Protection Certificates for MAXZIDE-25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

MAXZIDE-25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MAXZIDE-25

Introduction

MAXZIDE-25, a combination of hydrochlorothiazide and triamterene, is a potent diuretic used primarily to treat hypertension and edema. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Drivers

Several factors drive the market growth of MAXZIDE-25 and similar hydrochlorothiazide-based medications:

Increasing Prevalence of Hypertension

The global prevalence of hypertension is on the rise, with the World Health Organization (WHO) estimating that 1.13 billion people suffer from hypertension, a number expected to increase to 29% by 2025[1].

Geriatric Population Growth

The increasing geriatric population is another significant driver, as older adults are more likely to suffer from hypertension and other cardiovascular diseases[1].

FDA Approvals and R&D Activities

The rise in FDA approvals for new drugs and ongoing research and development activities by pharmaceutical companies also boost the market growth[1].

Market Trends

New Product Launches

The launch of novel drugs and combinations, such as MAXZIDE-25, which combines a potassium-conserving diuretic (triamterene) with a natriuretic agent (hydrochlorothiazide), enhances market growth by offering more effective treatment options[1][2].

Growing Awareness of Heart Diseases

Increased awareness and efforts to treat heart diseases contribute to the higher demand for diuretics like MAXZIDE-25[1].

Financial Trajectory

Price Increases

Pharmaceutical companies have been increasing the list prices of brand-name and generic drugs, including diuretics like MAXZIDE-25. For instance, prices for common diuretics have seen double-digit increases, with MAXZIDE-25 experiencing an 18% price hike recently[3].

Impact of PBMs

Pharmacy Benefit Managers (PBMs) play a crucial role in managing the financial impact of these price increases. PBMs negotiate with drugmakers and incentivize the use of less expensive alternatives, helping to mitigate the financial burden on health plans and patients. It is projected that PBMs will save health plan sponsors and consumers over $1 trillion from 2020 to 2029[3].

Competitive Landscape

Generic Competition

The generic drug industry is highly competitive, with prices falling as the number of competitors increases. However, generic prices remain above long-run marginal costs until there are 8 or more competitors in the market[4].

Key Market Players

Companies such as Beijing Second Pharmaceutical, Torrent Pharmaceuticals, Zhejiang Huahai Pharmaceutical, and others are key players in the hydrochlorothiazide market, including the production of MAXZIDE-25 and similar formulations[1].

Side Effects and Safety Concerns

Despite its effectiveness, MAXZIDE-25 comes with several side effects and safety concerns that can impact its market growth:

Hyperkalemia Risk

One of the significant risks associated with MAXZIDE-25 is the potential for hyperkalemia, especially in patients with diabetes, kidney disease, or severe illness. This condition can be deadly if not treated promptly[2][5].

Renal and Hepatic Impairment

The drug should be used cautiously in patients with renal or hepatic impairment, as it can exacerbate existing conditions such as renal stones or hepatic coma[2].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market dynamics of MAXZIDE-25. FDA approvals, safety guidelines, and monitoring of side effects are essential for maintaining the drug's market presence.

Global Market Outlook

The global hydrochlorothiazide market, including MAXZIDE-25, is expected to grow significantly due to the increasing prevalence of hypertension and other cardiovascular diseases. 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 medications[1].

Illustrative Statistics

• Hypertension Prevalence: 1.13 billion people globally suffer from hypertension, with an expected increase to 29% by 2025[1].
• Price Increases: An 18% price hike for MAXZIDE-25 and similar diuretics in recent months[3].
• PBM Savings: PBMs are projected to save over $1 trillion for health plan sponsors and consumers from 2020 to 2029[3].

Expert Insights

"Pharmaceutical companies continue to raise list prices year-over-year, but PBMs are actively working to lower costs for employers and patients by driving competition and negotiating with drugmakers," said an executive from a leading PBM[3].

Key Takeaways

• The market for MAXZIDE-25 is driven by increasing hypertension prevalence, geriatric population growth, and FDA approvals.
• Price increases are a significant trend, but PBMs help mitigate these costs.
• Safety concerns such as hyperkalemia and renal impairment need careful monitoring.
• The global market is expected to grow due to rising healthcare needs.

FAQs

Q: What is MAXZIDE-25 used for? A: MAXZIDE-25 is used to treat high blood pressure and edema.

Q: What are the potential side effects of MAXZIDE-25? A: Potential side effects include hyperkalemia, renal impairment, hepatic coma, and other electrolyte imbalances.

Q: How do PBMs impact the cost of MAXZIDE-25? A: PBMs negotiate with drugmakers and incentivize the use of less expensive alternatives, helping to lower costs for health plans and patients.

Q: What is the current market trend for hydrochlorothiazide-based drugs? A: The market is seeing price increases, but also benefits from new product launches and growing awareness of heart diseases.

Q: What regulatory considerations are important for MAXZIDE-25? A: FDA approvals, safety guidelines, and monitoring of side effects are crucial for maintaining the drug's market presence.

Citations

1. Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
2. FDA - MAXZIDE® TABLETS (triamterene and hydrochlorothiazide tablets, USP)
3. MedCity News - Pharma Just Increased the Price of Hundreds of Drugs. PBMs are Minimizing the Impact for Health Plans, Employers, and Patients.
4. Federal Trade Commission - Generic Drug Industry Dynamics
5. Drugs.com - Maxzide-25: Indications, Side Effects, Warnings