CARDIZEM Drug Patent Profile

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

Cardizem is a drug marketed by Biovail, Biovail Labs Intl, and Bausch. and is included in six NDAs.

The generic ingredient in CARDIZEM is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardizem

A generic version of CARDIZEM was approved as diltiazem hydrochloride by TEVA on May 31^st, 1995.

Summary for CARDIZEM

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	10
Drug Prices:	Drug price information for CARDIZEM
What excipients (inactive ingredients) are in CARDIZEM?	CARDIZEM excipients list
DailyMed Link:	CARDIZEM at DailyMed

See drug prices for CARDIZEM

Recent Clinical Trials for CARDIZEM

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

Sponsor	Phase
Assiut University	Early Phase 1
CAMC Health System	Phase 4
University of South Florida	N/A

See all CARDIZEM clinical trials

Pharmacology for CARDIZEM

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for CARDIZEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail	CARDIZEM	diltiazem hydrochloride	INJECTABLE;INJECTION	020792-001	Sep 5, 1997		DISCN	No	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003	AB	RX	Yes	Yes
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	AB	RX	Yes	Yes
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-001	Nov 5, 1982	AB	RX	Yes	No

Expired US Patents for CARDIZEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-001	Nov 5, 1982
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986

International Patents for CARDIZEM

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

Country	Patent Number	Title	Estimated Expiration
Germany	2226210
Sweden	337887
Germany	1643738	7-[3alpha,5alpha-Dihydroxy-2-(3-hydroxyoctenyl-(1))-cyclopentyl]-heptan-1-ol,dessen Tetraacetat und Verfahren zu deren Herstellung
Germany	1643740	Dihydro-PGF1ss,dessen Methylester und Methylerstertriacetat und Verfahren zur Herstellung dieser Verbindungen

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CARDIZEM

Last updated: July 29, 2025

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Introduction

CARDIZEM, a trade name for diltiazem, is a calcium channel blocker approved for managing hypertension, angina pectoris, and certain arrhythmias. Since its initial formulation, CARDIZEM has maintained a pivotal role within cardiovascular therapeutics, driven by its efficacy and versatility. This analysis explores the evolving market dynamics influencing CARDIZEM's trajectory and the financial outlook shaped by regulatory, competitive, and socioeconomic factors.

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Historical Context and Market Penetration

Introduced in the 1980s, CARDIZEM established itself as a leading pharmaceutical for cardiovascular indications due to its targeted mechanism of action and favorable safety profile. Its widespread adoption in hospitals and outpatient settings contributed significantly to its market share. Over the decades, generic formulations entered the market, leading to a notable decline in brand-name sales but ensuring broader patient access.

According to IQVIA data, CARDIZEM remains among the top prescribed calcium channel blockers in the U.S., with annual prescriptions exceeding 5 million [1]. Globally, the drug continues to be a staple amid rising prevalence of hypertension and cardiovascular diseases, especially in aging populations across Asia and Europe.

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Regulatory and Patent Landscape

The original patents for CARDIZEM have long expired, facilitating generic manufacturing and intensifying price competition. This patent expiry significantly broadened access but squeezed the revenue of the original formulation. Despite this, branded versions, including extended-release formulations and combination therapies, retain premium pricing in certain markets, especially where branded drugs are preferred due to perceived quality or formulary restrictions.

Regulatory bodies like the FDA and EMA continuously monitor both branded and generic versions for manufacturing quality, impacting market stability. Moreover, ongoing research for new indications and formulations sustains moderate innovation-driven revenues.

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Market Dynamics Influences

1. Competition and Generics

The entry of multiple generic manufacturers has transformed the market landscape into a price-sensitive environment. Generic versions of diltiazem are typically priced 70-80% lower than branded CARDIZEM, pressuring margins for the original manufacturer. Nonetheless, brands retain market segments through physician and patient loyalty, particularly in hospital settings.

2. Prescribing Trends and Clinical Guidelines

Guideline updates for hypertension and angina management increasingly favor newer or combination therapies, possibly marginally impacting diltiazem prescription volume [2]. However, the drug's proven efficacy ensures steady demand, especially in cases contraindicating certain drug classes.

3. Emerging Therapies and Innovations

Novel calcium channel blockers with improved pharmacokinetics or reduced side effect profiles could challenge CARDIZEM's dominance. Additionally, fixed-dose combination therapies involving diltiazem and other antihypertensives are gaining traction, influencing prescribing patterns and sales.

4. Global Epidemiology and Demographic Shifts

The rising prevalence of hypertension, especially in developing economies, secures a steady demand trajectory. World Health Organization projections indicate a 25% increase in hypertension prevalence by 2030, complementing the continued need for accessible medications like CARDIZEM [3].

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Financial Trajectory Outlook

1. Revenue Projections

Post-patent expiry, sales of CARDIZEM have stabilized at a lower plateau, primarily driven by chronic guideline-based use. The global market size for diltiazem-based therapies is estimated at approximately USD 900 million annually [4]. Regional variations are significant, with North America accounting for roughly 50% of the market share.

2. Profitability and Cost Structure

Branded formulations maintain higher margins due to brand premiums, whereas generics operate on thin margins. Manufacturing and regulatory compliance costs continue to influence profitability. Companies investing in marketing and clinician education still realize higher market penetration, sustaining revenue streams.

3. Future Growth Drivers

• Extended-Release Formulations: Demand for improved adherence through extended-release versions is growing, maintaining premium pricing.
• Combination Therapies: Co-formulations with antihypertensives or antianginal agents expand market potential.
• Emerging Markets: Accelerated urbanization and health infrastructure improvements in Asia-Pacific increase prescription volumes.

4. Potential Risks

• Market Saturation: High generic penetration limits growth opportunities.
• Regulatory Challenges: Stringent manufacturing standards could raise costs.
• Innovation Gaps: Lack of significant new indications for diltiazem could dampen revenue prospects.

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Competitive Landscape

Major pharmaceutical players such as Pfizer, Teva, Mylan, and Sun Pharmaceutical dominate the generic diltiazem market, while Novo Nordisk and others hold rights to branded formulations. The competitive intensity exerts downward pressure on prices but sustains volume-driven revenues.

South Asian and Latin American markets present cost-sensitive growth opportunities due to expanding healthcare access, although regulatory hurdles may slow penetration.

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Impact of Socioeconomic Factors

The global increase in cardiovascular risk factors, coupled with an aging demographic, sustains demand. However, disparities in healthcare access, prescription practices, and pricing pressures create uneven market probabilities across regions. Policymaker initiatives to contain healthcare costs reinforce the reliance on generics, influencing the financial trajectory.

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Regulatory and Patent Strategies

Manufacturers emphasize formulation innovations—such as modified-release systems and combination products—to extend life cycles. Some companies pursue patent strategies around specific delivery mechanisms to delay generic competition, though these are often challenged legally.

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Key Opportunities and Challenges

• Opportunities: Growing demand in emerging markets; development of novel formulations; strategic partnerships for extended indications.
• Challenges: Price erosion; competition from new therapeutic classes; regulatory complexities; market saturation.

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Conclusion

The market dynamics for CARDIZEM underscore a landscape characterized by mature, volume-driven sales amid intense generic competition. Financially, manufacturers focus on extending product life cycles through formulation innovations and regional expansion. The drug’s long-standing efficacy secures its presence in cardiovascular therapeutics, but future growth hinges on innovation, strategic market positioning, and navigating regulatory pathways.

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Key Takeaways

• Brand-name revenue for CARDIZEM has declined due to patent expiry and generic competition but remains resilient in specific niches.
• Growth opportunities exist in emerging markets, extended-release formulations, and combination therapies.
• Price competition in the generics space constrains profit margins, emphasizing cost efficiency and differentiated formulations.
• Demographic shifts and rising cardiovascular disease prevalence support sustained demand.
• Strategic innovation and regional expansion are critical to optimizing CARDIZEM’s financial trajectory.

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FAQs

1. What factors contributed to the decline in CARDIZEM’s brand revenue?
Patent expirations, the proliferation of generic manufacturers, and pricing pressures significantly reduced brand-name sales, although niche markets and formulations retain premium pricing.

2. How does the global prevalence of hypertension influence CARDIZEM’s market?
The rising prevalence of hypertension globally, particularly in aging populations, ensures a consistent demand for calcium channel blockers like CARDIZEM.

3. What competitive strategies are pharmaceutical companies employing for CARDIZEM?
Innovations in extended-release formulations, combination therapies, regional market targeting, and legal patent strategies to extend product lifecycle.

4. Are there clinical developments that could impact CARDIZEM’s position?
Yes, new class drugs with better safety profiles or efficacy, and alternative therapies for hypertension and angina, may challenge CARDIZEM’s market share.

5. What are the growth prospects for CARDIZEM in emerging markets?
Significant, given increasing healthcare access, rising cardiovascular disease burden, and demand for affordable medications, though regulatory and infrastructural challenges persist.

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References

[1] IQVIA. (2022). Global Prescription Data Analysis.
[2] American College of Cardiology. (2023). Guidelines for Hypertension Management.
[3] WHO. (2021). Hypertension Prevalence and Impact.
[4] MarketWatch. (2022). Global Calcium Channel Blocker Market Size & Forecast.

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Disclaimer: This detailed synthesis provides a professional analysis based on current market data and scientific literature as of 2023. Continuous market shifts warrant ongoing monitoring for accurate strategic decision-making.