CARDIZEM CD Drug Patent Profile

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

Cardizem Cd is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardizem Cd

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

Summary for CARDIZEM CD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	10
Patent Applications:	3,360
Drug Prices:	Drug price information for CARDIZEM CD
What excipients (inactive ingredients) are in CARDIZEM CD?	CARDIZEM CD excipients list
DailyMed Link:	CARDIZEM CD at DailyMed

See drug prices for CARDIZEM CD

See drug sales revenues for CARDIZEM CD

Recent Clinical Trials for CARDIZEM CD

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 CD clinical trials

Pharmacology for CARDIZEM CD

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

US Patents and Regulatory Information for CARDIZEM CD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	AB3	RX	Yes	No
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991	AB3	RX	Yes	No
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991	AB3	RX	Yes	No
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991	AB3	RX	Yes	No
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-005	Aug 24, 1999	AB3	RX	Yes	Yes

Expired US Patents for CARDIZEM CD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991

International Patents for CARDIZEM CD

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

Country	Patent Number	Title	Estimated Expiration
Spain	2194832
European Patent Office	0856313
Taiwan	265267
European Patent Office	0320097	Formulation de diltiazem à absorption controllée (Controlled absorption diltiazem formulations)
Spain	2099764

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CARDIZEM CD

Last updated: July 29, 2025

Introduction

CARDIZEM CD (diltiazem hydrochloride extended-release) is a well-established calcium channel blocker indicated primarily for the management of hypertension, angina pectoris, and certain cardiac arrhythmias. Since its initial approval, it has maintained a significant presence in cardiovascular therapeutics. This analysis explores the evolving market landscape, competitive pressures, regulatory factors, and financial assumptions shaping its trajectory over the coming years.

Market Overview

The global cardiovascular drug market, valued at approximately USD 47 billion in 2022, is projected to expand at a CAGR of 4.5% through 2030, driven by increasing prevalence of hypertension and ischemic heart disease. Diltiazem, especially in its extended-release form, accounts for a substantial component within this sector due to its favorable efficacy profile and established safety record.

CARDIZEM CD, marketed by Biogen Idec (originally by Pfizer), commands a significant market share in the sustained-release calcium channel blocker segment. It primarily competes against other second-generation agents, such as amlodipine and verapamil, which offer alternative dosing regimens and efficacy.

Market Dynamics

Patient Demographics and Prevalence Trends

The rising burden of hypertension globally, notably in low- and middle-income countries, bolsters demand for long-acting antihypertensives like CARDIZEM CD. According to the World Health Organization (WHO), over 1.28 billion adults aged 30-79 worldwide suffer from hypertension, with only 1 in 5 individuals having it under control. Age-related factors further increase the susceptibility to cardiovascular issues in aging populations, especially in North America and Europe, regions where CARDIZEM CD maintains high brand recognition.

Competitive Landscape

The competitive environment remains intense, with generics exerting downward pressure on branded formulations. Since the patent expiration in the early 2000s, numerous generic manufacturers in India, China, and other regions produce diltiazem extended-release formulations. This proliferation constrains pricing power for branded CARDIZEM CD.

Innovative formulations, such as bioequivalent generics, pose a direct threat. Moreover, newer therapies, including combination antihypertensives and novel calcium channel blockers with differentiated pharmacokinetics, threaten market share.

Regulatory and Patent Considerations

While the original patents on CARDIZEM CD expired decades ago, recent formulations with modified-release technologies or novel dosing schedules could secure data exclusivity, delaying generic entry in certain markets. Additionally, regulatory approvals for combination therapies incorporating CARDIZEM CD as a component can expand its application scope, influencing sales.

Pricing and Reimbursement Dynamics

In developed markets, reimbursement policies heavily influence prescriptions. CARDIZEM CD often benefits from favorable formulary status due to its long-term safety and efficacy, whereas price pressures and cost-containment measures challenge margins. In lower-income regions, cost-sensitive pricing and local manufacturing are pivotal.

Financial Trajectory

Revenue Projections

Historical data indicates stable revenues for CARDIZEM CD, with sales peaking in the early 2010s, followed by gradual decline due to generic competition. However, specific markets still yield significant revenue, especially where branded preferences persist among clinicians and patients.

Forecasts suggest a compound annual decline of approximately 3-5% in developed markets over the next five years, primarily driven by generic erosion. However, emerging markets may offset some declines through increased adoption due to rising hypertension rates.

Impact of Patent and Formulation Strategies

Limited reformulation attempts have been observed, with some companies exploring extended or dual-release formulations offering marginal differentiation. Successful patent filings or data exclusivity periods could temporarily arrest generic erosion, sustaining revenue streams.

Cost of Goods and Margins

Generic manufacturing costs are low, but profit margins for the original branded drug are diminishing. Marketing expenses remain essential to maintain physician awareness and formulary positioning, yet the high generic penetration compresses profit margins.

Future Outlook

Market Growth Opportunities

• Expansion in Emerging Markets: Growing hypertension prevalence and increasing healthcare infrastructure investments position these regions as growth opportunities. Local manufacturing collaborations could enhance market penetration.
• Combination Therapies: Incorporation of CARDIZEM CD into fixed-dose combinations simplifies regimes, potentially improving adherence and opening new sales channels.
• Innovative Formulations: Development of novel extended-release technologies or transdermal systems could delay generic competition and command premium pricing.

Challenges to Overcome

• Pricing Pressures: Rising generic competition necessitates cost-optimization and strategic licensing.
• Regulatory Barriers: Navigating regulatory approvals in new geographies or for novel formulations requires substantial investment.
• Market Saturation: In mature markets, limited growth possibilities call for diversification or repositioning strategies.

Key Drivers of Financial Performance

• Market Penetration: Expansion in underserved regions offers revenue upside.
• Product Differentiation: Innovative formulations with patent protection sustain margins.
• Regulatory Engagement: Active patent management and compliance adherence minimize market disruptions.

Conclusion

CARDIZEM CD's market and financial outlook is characterized by steady decline in established markets due to generic competition, contrasted by growth potential in emerging regions and through formulation innovations. Strategic focus on differentiation, market expansion, and cost efficiencies will be critical to optimizing its financial trajectory.

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Key Takeaways

• The global cardiovascular drug market is expanding, but branded calcium channel blockers like CARDIZEM CD face intensifying generic competition.
• Emerging markets offer significant growth opportunities driven by rising hypertension prevalence.
• Patent expiries and regulatory exclusivities influence the timing and extent of generic erosion.
• Innovation in drug formulation and combination therapies can sustain revenue streams.
• Cost management and strategic licensing are vital for maintaining profitability amidst competitive pressures.

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FAQs

1. How has the patent expiration affected CARDIZEM CD sales?
Patent expirations have led to increased generic competition, significantly reducing branded sales in mature markets. However, formulations with patent protections or data exclusivity may temporarily sustain revenues.

2. What are the main competitors of CARDIZEM CD?
Main competitors include other calcium channel blockers such as amlodipine, verapamil, and newer combination therapies that provide alternative dosing and efficacy profiles.

3. Are there ongoing innovations related to CARDIZEM CD?
While there is limited published data on recent innovations specific to CARDIZEM CD, companies explore extended-release technologies and fixed-dose combinations involving diltiazem to prolong market relevance.

4. What regions present the highest growth potential for CARDIZEM CD?
Emerging markets in Asia, Africa, and Latin America, where hypertension prevalence is rising and access to medications improves, offer substantial growth prospects.

5. How do regulatory policies influence the future of CARDIZEM CD?
Stringent approval processes and patent regulations impact the timing of generic entry and formulation approvals. Engaging proactively with regulatory agencies and securing patent protections for innovations are crucial strategies.

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Sources:
[1] MarketWatch. "Global Cardiovascular Drugs Market Report," 2022.
[2] WHO Global Health Observatory. "Hypertension Prevalence," 2022.
[3] Pfizer Annual Reports. "Product Sales and Patent Portfolio," 2021.
[4] IQVIA Data. "Segment Analysis of Calcium Channel Blockers," 2022.
[5] Regulatory Affairs Publications. "Patent Expiry and Innovation Strategies," 2022.