PRINZIDE Drug Patent Profile

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

Prinzide is a drug marketed by Merck and is included in one NDA.

The generic ingredient in PRINZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for PRINZIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	1
Patent Applications:	3,817
DailyMed Link:	PRINZIDE at DailyMed

Recent Clinical Trials for PRINZIDE

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

Sponsor	Phase
Centre Hospitalier Universitaire de Saint Etienne	Phase 4

See all PRINZIDE clinical trials

US Patents and Regulatory Information for PRINZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-003	Nov 18, 1993		DISCN	Yes	No
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-001	Feb 16, 1989		DISCN	Yes	No
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989		DISCN	Yes	No

Expired US Patents for PRINZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989	4,374,829*PED
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-003	Nov 18, 1993	4,374,829*PED
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989	4,472,380
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-001	Feb 16, 1989	4,472,380

International Patents for PRINZIDE

See the table below for patents covering PRINZIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1275349	DERIVES D'ACIDE AMINIQUE (AMINO ACID DERIVATIVES)
Zimbabwe	24479	AMINO ACID DERIVATIVES AS ANTIHYPERTENSIVES
Slovenia	7913000	PROCESS FOR OBTAINING DERIVATIVES OF CARBOXYALKYLDIPEPTIDES
Morocco	18664

Supplementary Protection Certificates for PRINZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

PRINZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: PRINZIDE

Introduction

PRINZIDE, a combination of lisinopril and hydrochlorothiazide, is a widely used medication for the treatment of hypertension. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients alike.

Market Indications and Usage

PRINZIDE is specifically indicated for the treatment of hypertension and is not recommended for initial therapy. It combines an angiotensin-converting enzyme (ACE) inhibitor, lisinopril, with a diuretic, hydrochlorothiazide, making it a potent antihypertensive agent[1].

Patient Demographics and Response

The efficacy of PRINZIDE has been observed across various patient demographics. However, it is noteworthy that the antihypertensive effect of PRINZIDE 20-12.5 and PRINZIDE 20-25 combinations appeared somewhat less effective in Black patients compared to Caucasian patients, although the number of Black patients studied was relatively small[1].

Market Competition

The antihypertensive drug market is highly competitive, with numerous drugs available for treating hypertension. PRINZIDE competes with other ACE inhibitors and diuretics, as well as other classes of antihypertensive medications. The competitive landscape is influenced by factors such as efficacy, side effect profiles, and pricing strategies[3].

Pricing Strategies

Pharmaceutical companies often employ differential pricing strategies, offering discounts to different segments of the market. For PRINZIDE, pricing can vary based on the strength of the formulation and the market segment. Discounts may be offered to large buyers such as hospitals, health maintenance organizations (HMOs), and pharmacy benefit managers (PBMs)[3].

Impact of Vertical Consolidation

The pharmaceutical industry has seen significant vertical consolidation, with drug companies acquiring PBMs and entering into vertical contracts with HMOs. These arrangements can influence the pricing and availability of drugs like PRINZIDE. For instance, volume-based rebate provisions in contracts can lead to exclusive dealing arrangements that may affect the competitive dynamics and prices of the drug[3].

Regulatory Considerations

PRINZIDE, like other prescription drugs, is subject to stringent regulatory oversight. The FDA has specific guidelines for its use, particularly regarding its contraindications during pregnancy and potential risks such as angioedema and hyperkalemia. Compliance with these regulations can impact the drug's market trajectory[1].

Financial Performance

The financial performance of PRINZIDE is influenced by several factors, including sales volume, pricing, and market competition. As a combination therapy, it benefits from the synergistic effects of its two active ingredients, which can enhance patient compliance and reduce the need for multiple prescriptions. This can lead to higher sales and revenue for the drug.

Sales Volume and Market Share

PRINZIDE's sales volume is significant due to its efficacy and the widespread prevalence of hypertension. The drug's market share can fluctuate based on the introduction of new antihypertensive medications and changes in prescribing practices.

Pricing and Discounts

The pricing of PRINZIDE is a critical factor in its financial performance. Discounts offered to large buyers can reduce the average revenue per unit but increase overall sales volume. This strategy can help maintain market share and revenue in a competitive market.

Cost Savings and Importation

In some regions, importation programs can affect the pricing and availability of PRINZIDE. For example, programs that allow the importation of prescription drugs from countries like Canada can offer significant cost savings, potentially impacting the domestic market for the drug[4].

Quality of Care and Performance Metrics

The quality of care associated with PRINZIDE is measured through various performance metrics, such as blood pressure control rates and patient outcomes. National quality forums and healthcare organizations track these metrics to ensure that antihypertensive treatments, including PRINZIDE, meet high standards of care[2].

Challenges and Opportunities

Side Effects and Safety Concerns

PRINZIDE, like other ACE inhibitors and diuretics, comes with potential side effects such as cough, hyperkalemia, and renal function changes. Managing these risks is crucial for maintaining patient safety and trust in the drug[1].

Market Expansion

Despite the competitive landscape, there are opportunities for market expansion, particularly in regions with high prevalence of hypertension. Educational campaigns and clinical trials demonstrating the efficacy and safety of PRINZIDE can help increase its market share.

Generic Competition

The expiration of patents for branded drugs like PRINZIDE can lead to generic competition, which can significantly impact the financial trajectory of the drug. Generic versions often offer lower prices, which can erode the market share of the branded product.

Key Takeaways

• Market Indications: PRINZIDE is specifically indicated for the treatment of hypertension.
• Patient Response: The drug's efficacy varies slightly across different patient demographics.
• Pricing Strategies: Differential pricing and discounts to large buyers are common.
• Regulatory Compliance: Strict adherence to FDA guidelines is necessary.
• Financial Performance: Influenced by sales volume, pricing, and market competition.
• Quality Metrics: Measured through blood pressure control rates and patient outcomes.
• Challenges and Opportunities: Managing side effects, market expansion, and generic competition are key considerations.

FAQs

Q: What are the primary components of PRINZIDE?

A: PRINZIDE combines an angiotensin-converting enzyme (ACE) inhibitor, lisinopril, with a diuretic, hydrochlorothiazide.

Q: Is PRINZIDE recommended for initial therapy in hypertension?

A: No, PRINZIDE is not indicated for initial therapy; it is typically used after other treatments have been considered.

Q: What are the potential side effects of PRINZIDE?

A: Potential side effects include cough, hyperkalemia, and changes in renal function.

Q: How does vertical consolidation in the pharmaceutical industry affect PRINZIDE?

A: Vertical consolidation can influence pricing and availability through contracts with HMOs and PBMs, potentially leading to exclusive dealing arrangements.

Q: What impact does generic competition have on PRINZIDE's market share?

A: Generic competition can significantly erode the market share of PRINZIDE by offering lower-priced alternatives.

Sources

1. FDA Label for PRINZIDE: accessdata.fda.gov
2. National Quality Forum: qualityforum.org
3. FTC Report on Pharmaceutical Industry: ftc.gov
4. Prescription Drug Reimportation in Connecticut: portal.ct.gov