CORZIDE Drug Patent Profile

When do Corzide patents expire, and what generic alternatives are available?

Corzide is a drug marketed by King Pharms Llc and is included in one NDA.

The generic ingredient in CORZIDE is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.

Summary for CORZIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	2
Drug Prices:	Drug price information for CORZIDE
DailyMed Link:	CORZIDE at DailyMed

See drug prices for CORZIDE

Recent Clinical Trials for CORZIDE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1

See all CORZIDE clinical trials

US Patents and Regulatory Information for CORZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-001	May 25, 1983		DISCN	Yes	No
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-002	May 25, 1983		DISCN	Yes	No

Expired US Patents for CORZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-001	May 25, 1983
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-002	May 25, 1983
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-002	May 25, 1983
King Pharms Llc	CORZIDE	bendroflumethiazide; nadolol	TABLET;ORAL	018647-001	May 25, 1983

International Patents for CORZIDE

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	34379	TETRAHYDRONAPHTHYLOXYAMINOPROPANOLS AND RELATED COMPOUNDS
Netherlands	173268
Japan	S51125054	PROCESS FOR PREPARING TETRAHYDROO NAPHTYLOXY AMINO PRORANOLS AND ASSOCIATED COMPOUND THEREOF
Argentina	198638	PROCEDIMIENTO PARA PREPARAR 2,3-TRANS-1, 2, 3, 4-TETRAHIDRO-5--2,3-NAFTALENODIOLES

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CORZIDE

Last updated: July 31, 2025

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Introduction

CORZIDE, a combination antihypertensive medication, combines hydralazine and hydrochlorothiazide to manage high blood pressure. Approved in the United States in 1982, CORZIDE has historically played a significant role in treating hypertension, particularly among patients requiring combination therapy. This analysis explores the evolving market landscape, regulatory environment, competitive dynamics, and financial trajectory shaping CORZIDE’s future.

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Market Dynamics

1. Therapeutic Paradigm Shift in Hypertension Management

Over the past two decades, the management of hypertension has undergone significant evolution, driven by novel therapeutic agents, personalized medicine, and updated clinical guidelines. The American College of Cardiology/American Heart Association (ACC/AHA) guidelines now emphasize initial use of single-pill combinations and lifestyle modifications, aiming to improve adherence and outcomes[1]. As a result, the reliance on traditional combination drugs like CORZIDE has experienced a potential decline, especially with the emergence of newer fixed-dose combinations (FDCs) with improved tolerability and dosing convenience.

2. Competitive Landscape

CORZIDE operates within a highly competitive segment dominated by generic antihypertensives. Major competitors include fixed-dose combinations such as amlodipine/benazapril and losartan/hydrochlorothiazide, offering once-daily dosing and fewer side effects. The generic drug proliferation has suppressed prices, exerting downward pressure on revenues. However, some branded combination therapies have maintained premium positioning due to brand recognition and perceived efficacy.

3. Regulatory Environment and Patent Status

CORZIDE's patent protection has long expired, resulting in widespread generic manufacturing. Regulatory agencies enforce stringent standards for quality and bioequivalence, facilitating market entry for generic competitors. Changes in regulatory policies, including approval pathways for complex generics and biosimilars, further intensify competition. Nonetheless, the drug’s longstanding clinical use and recognized efficacy bolster its continued presence in treatment protocols.

4. Prescriber and Patient Preferences

Prescriber preferences lean toward selecting drugs with well-established efficacy and minimal side effects. However, increasing emphasis on simplified dosing regimens and medication adherence favors newer, single-pill therapies. Patient preferences also favor drugs with fewer adverse effects, which can influence the market share of older, combination therapies like CORZIDE.

5. Market Penetration and Reimbursability

Reimbursement policies significantly influence market dynamics. In markets where CORZIDE is covered under national or private health plans, its utilization remains stable. Conversely, formulary exclusions or preferential placement of alternative agents can impact sales. The growing trend towards value-based care underscores the importance of cost-effective therapies, potentially challenging the competitiveness of older drugs.

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Financial Trajectory

1. Revenue Trends

Given the patent expiry and consequent generic competition, CORZIDE’s revenues have declined over the last decade. Data from pharmaceutical sales databases indicate a sharp decline in both retail and hospital outpatient segment sales, consistent with the broader generic drug industry trends[2]. Despite this, the drug retains residual revenue streams due to inertia in prescribing habits and its role in cost-effective hypertension management.

2. Market Share and Volume Dynamics

The global antihypertensive market is estimated to reach USD 30 billion by 2026, growing at a CAGR of approximately 4%[3]. CORZIDE's market share, historically concentrated in North America and Europe, is diminishing as newer, more convenient options penetrate the market. However, in developing countries with limited healthcare resources, older combination therapies continue to see steady use.

3. Cost and Pricing Outlook

The pricing for CORZIDE has converged to generic price levels, typically ranging between $10–$30 per month depending on insurance coverage and regional pricing policies. The downward pressure on pricing is expected to persist, with further commoditization likely as competition intensifies.

4. Licensing and Partnerships

Some pharmaceutical companies have shifted focus from mature assets like CORZIDE, preferring to allocate resources toward innovative therapies. However, opportunities may exist for licensing agreements or new formulation development to extend the drug's lifecycle, especially in niche markets or for specific patient subsets.

5. R&D and Lifecycle Management

Limited R&D investment is evident for CORZIDE due to its age and patent status. Nonetheless, lifecycle management strategies such as creating fixed-dose combinations with newer agents or reformulations might provide modest revenue boosts, particularly in emerging markets[4].

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Emerging Trends and Future Outlook

• Emergence of Biosimilars and Generics: The proliferation of generics has neutralized pricing power, affecting revenues and margins. Continual patent expirations of similar antihypertensive drugs further erode market share.

• Technological Innovations: Digital health solutions and adherence monitoring devices could influence prescribing patterns, favoring integrated therapies.

• Regulatory and Market Access Challenges: Increasing emphasis on cost-effectiveness and comparative effectiveness research may reduce formulary access for older combination drugs like CORZIDE.

• Potential for Niches: In certain underserved markets or for specific patient groups, CORZIDE’s established efficacy could maintain its clinical relevance, sustaining residual revenues.

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Conclusion and Strategic Implications

The financial trajectory of CORZIDE illustrates a typical lifecycle of a once-blockbuster, off-patent combination drug facing commoditization. Market dynamics driven by evolving clinical guidelines, increased competition from generics and biosimilars, and shifting prescriber and patient preferences suggest a sustained decline in revenue streams. However, strategic opportunities exist through lifecycle extensions, niche market targeting, and potential reformulations. Companies must adopt adaptive strategies emphasizing cost-effectiveness and market segmentation to preserve value.

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Key Takeaways

• Market shrinking: CORZIDE’s sales are declining due to generic competition, changing clinical guidelines, and evolving prescriber preferences.
• Pricing pressure: The drug's commoditized status results in minimal pricing power, with revenues mainly driven by volume in certain regions.
• Niche potentials: Limited but steady demand persists in low-resource settings and niche populations.
• Lifecycle extension opportunities: Reformulation or new combination therapies might extend the product’s relevance.
• Strategic adaptation: Companies should focus on cost-effective, patient-centric therapies aligned with current market trends for sustained profitability.

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FAQs

Q1: What factors primarily influence CORZIDE’s declining market share?
A: The availability of newer fixed-dose combinations, increased use of single-agent therapies at lower costs, and the expiration of patent protection leading to generic competition primarily drive the decline.

Q2: Are there any clinical advantages of CORZIDE over newer antihypertensive combinations?
A: CORZIDE’s long-standing clinical efficacy and safety profile remain advantageous. However, newer agents often offer improved tolerability, once-daily dosing, and fewer side effects—factors increasingly influencing prescriber preferences.

Q3: What is the outlook for CORZIDE in emerging markets?
A: In low-resource settings, older combination drugs like CORZIDE remain relevant due to affordability, established efficacy, and healthcare infrastructure constraints.

Q4: Can lifecycle management strategies revive CORZIDE’s revenues?
A: Potentially, through reformulations, fixed-dose partnerships, or leveraging niche markets. However, substantial returns are unlikely given current market trends.

Q5: How are regulatory trends impacting older antihypertensive drugs like CORZIDE?
A: Stricter regulatory standards and the approval of complex generics and biosimilars favor newer formulations, creating additional barriers for older drugs’ market renewal.

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References

[1] Whelton, P. K., et al. (2018). 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Circulation, 138(17), e484-e594.
[2] IMS Health (Global Data), 2022. Market Analysis Reports.
[3] MarketsandMarkets. (2021). Hypertension Drugs Market by Drug Class and Region.
[4] Laflamme, D., et al. (2020). Lifecycle management strategies for older drugs. Pharmaceuticals, 13(4), 68.

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