MAXZIDE Drug Patent Profile

Which patents cover Maxzide, and what generic alternatives are available?

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

The generic ingredient in MAXZIDE 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

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	1
Drug Prices:	Drug price information for MAXZIDE
DailyMed Link:	MAXZIDE at DailyMed

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See drug sales revenues for MAXZIDE

Recent Clinical Trials for MAXZIDE

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

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

See all MAXZIDE clinical trials

US Patents and Regulatory Information for MAXZIDE

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	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984	AB	RX	Yes	Yes
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	AB	RX	Yes	No

Expired US Patents for MAXZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984

International Patents for MAXZIDE

See the table below for patents covering MAXZIDE 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

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Maxzide

Introduction

Maxzide, a combination drug of triamterene and hydrochlorothiazide, is a significant player in the treatment of high blood pressure and swelling. Developed by Mylan, this drug has an intriguing market and financial history that reflects broader trends in the generic drug industry.

Development and Approval

Maxzide was introduced by Mylan after the patent for Dyazide, a similar combination drug, expired. Mylan developed a new formulation with different dosages of each active ingredient (50 mg hydrochlorothiazide and 75 mg triamterene) compared to Dyazide (25 mg hydrochlorothiazide and 50 mg triamterene). This new formulation allowed for once-daily dosing, which Mylan believed would give it a competitive edge against Dyazide, which had significant sales of $210 million in 1983[1].

Market Entry and Competition

Maxzide was approved in 1984, and its higher dose formulation was seen as a strategic move to capture market share. However, Mylan's patents on Maxzide were later declared invalid in court, and its marketing exclusivity expired in 1987. This led to a surge of generic competition, with companies like American Therapeutics Inc. and Vitarine Pharmaceuticals entering the market. Interestingly, Vitarine and Par Pharmaceutical were found to have used Mylan's Maxzide data to obtain bioequivalence, leading them to withdraw their generic versions temporarily[1].

Financial Performance

During its initial years, Maxzide contributed significantly to Mylan's financial growth. In the early 2000s, Mylan reported substantial increases in net revenues, gross profit, and net earnings. For instance, in fiscal 2002, Mylan's net revenues exceeded $1.1 billion, a 30% increase from the previous year, with gross profit increasing by 63% to $623.9 million and net earnings rising by 98% to $260.3 million[3].

Impact on Mylan's Growth Strategy

Maxzide was part of Mylan's broader strategy of selective product management and controlled growth. The company focused on maintaining high profit margins through the strategic selection of products with solid demand and technological exclusivities. Mylan's ability to manufacture over 95% of its dosage units also helped in controlling service levels and achieving higher profit margins[3].

Generic Drug Industry Dynamics

The entry of generic competitors into the Maxzide market illustrates key dynamics of the generic drug industry. More firms enter markets with greater expected rents, and prices fall as the number of competitors increases. However, prices remain above long-run marginal costs until there are eight or more competitors. This pattern is consistent with broader industry trends where generic drug prices decline with increased competition but do not immediately reach long-run marginal costs[4].

Market Share and Prescription Volume

Despite the entry of generics, Mylan managed to maintain market share through effective marketing and product differentiation. For example, in fiscal 2002, Mylan saw significant growth in prescription volumes for several of its products, including a new once-daily form of phenytoin, which was approved in December 2001[3].

Regulatory and Litigation Challenges

The journey of Maxzide was not without regulatory and litigation challenges. Mylan's investigation into corruption and the use of its bioequivalence data by competitors led to legal battles. This highlights the complex regulatory environment and the importance of intellectual property protection in the pharmaceutical industry[1].

Consumer Demand and Technological Exclusivities

Maxzide's success was also driven by consumer demand and technological exclusivities. The once-daily dosing regimen was a significant selling point, making it more convenient for patients compared to other diuretic combinations. This convenience factor, combined with effective marketing, helped in maintaining a strong market presence[1].

Future Growth and Market Positioning

As the generic drug market continues to evolve, products like Maxzide remain crucial for companies like Mylan. The company's strategy of introducing new formulations and maintaining a robust generic pipeline positions it well for future growth. Mylan's focus on quality, people, and strategic product management has been key to its success and will continue to be important as the market becomes increasingly competitive[3].

Key Takeaways

• Market Entry and Competition: Maxzide's entry into the market was strategic, with a new formulation allowing once-daily dosing.
• Financial Performance: Maxzide significantly contributed to Mylan's financial growth in the early 2000s.
• Generic Drug Industry Dynamics: The entry of generics led to price reductions, but prices remained above long-run marginal costs until multiple competitors entered.
• Regulatory and Litigation Challenges: Mylan faced regulatory and litigation issues, including the use of its bioequivalence data by competitors.
• Consumer Demand and Technological Exclusivities: The convenience of once-daily dosing and effective marketing were key to Maxzide's success.

FAQs

What is Maxzide, and how does it differ from Dyazide?

Maxzide is a combination drug of triamterene and hydrochlorothiazide, developed by Mylan. It differs from Dyazide in its dosages (50 mg hydrochlorothiazide and 75 mg triamterene vs. 25 mg hydrochlorothiazide and 50 mg triamterene) and allows for once-daily dosing[1].

How did Mylan's patents on Maxzide impact its market exclusivity?

Mylan's patents on Maxzide were declared invalid in court, leading to the expiration of its marketing exclusivity in 1987 and the entry of generic competitors[1].

What were the financial implications of Maxzide for Mylan?

Maxzide contributed significantly to Mylan's financial growth, with net revenues exceeding $1.1 billion in fiscal 2002, a 30% increase from the previous year[3].

How does the generic drug industry's competitive environment affect prices?

In the generic drug industry, prices fall as the number of competitors increases, but they remain above long-run marginal costs until there are eight or more competitors[4].

What role did consumer demand and technological exclusivities play in Maxzide's success?

The convenience of once-daily dosing and effective marketing, driven by consumer demand and technological exclusivities, were crucial factors in Maxzide's market success[1].

Sources

1. Wikipedia: Triamterene
2. PMC: Multicenter validation of a machine learning phase space electro...
3. Mylan 2002 Annual Report: Mylan 2002 Annual Report
4. Federal Trade Commission: Generic Drug Industry Dynamics
5. National Quality Forum: NATIONAL QUALITY FORUM