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-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

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
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-005	Aug 24, 1999	AB3	RX	Yes	Yes
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-002	Jan 23, 1989		DISCN	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	018602-003	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
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-002	Nov 5, 1982

International Patents for CARDIZEM

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	7300256	BENZOTHIAZEPINE DERIVATIVES
Denmark	126106
Denmark	129336
Germany	2226210
Denmark	131462
Denmark	130067

Market Dynamics and Financial Trajectory for CARDIZEM (Diltiazem)

Last updated: March 26, 2026

What Is the Current Market Position of CARDIZEM?

CARDIZEM, branded as Diltiazem, is a calcium channel blocker used to treat hypertension, angina, and certain arrhythmias. It is marketed primarily by Pfizer and has been approved globally. The product maintains steady market presence due to established therapeutic efficacy, price stability, and existing patent protections in key jurisdictions.

How Is the Market for Diltiazem Evolving?

Market Size and Growth

• The global calcium channel blocker market was valued at approximately USD 3.2 billion in 2021.
• CAGR projected at 4.8% from 2022 to 2028. This growth is driven by increasing prevalence of cardiovascular diseases (CVDs), particularly hypertension.
• Diltiazem accounted for roughly 22% of the calcium channel blocker segment in 2021, making it a significant contributor.

Regional Market Breakdown

Region	Market Share (2021)	Growth Rate (2022-2028 forecast)
North America	42%	5.0%
Europe	25%	4.5%
Asia-Pacific	20%	6.0%
Rest of World	13%	4.2%

Growing healthcare expenditure, increased awareness, and population aging are key factors influencing regional demand, especially in Asia-Pacific nations.

Competitive Landscape

• Major competitors include Cardizem CD (Boehringer Ingelheim), Tiazac (Turmeric), and generic formulations.
• The patent landscape is complex; Pfizer's patent protections have largely expired in many countries, leading to increased generic market share.
• Generics now dominate in North America and Europe, exerting downward pressure on prices and margins for branded Diltiazem.

What Are Key Drivers and Challenges?

Drivers

• Rising incidence of hypertension and CVD globally, especially in aging populations.
• Expansion into emerging markets where healthcare infrastructure improves.
• The continuation of label expansions, including new formulations and extended-release options.

Challenges

• Patent expiry reduces exclusivity, leading to increased generic competition.
• Price erosion in mature markets influences revenue stability.
• Alternative therapies, such as newer antihypertensives, gain market share if marketed competitively.

How Do Regulatory Policies Impact Diltiazem's Market and Financial Trajectory?

• Patent cliff: Pfizer’s Diltiazem patent expiration in the US occurred in 2011. Generic versions have since taken significant market share.
• Regulatory approvals for generics require bioequivalence studies, facilitating easier market entry.
• In emerging markets, regulatory pathways are less stringent, enabling faster market penetration of generics.
• Recent policies promoting biosimilars and generics under cost-control initiatives exert downward pressure on branded product revenues.

What Is the Revenue and Profit Outlook?

Historical Financials

Year	Revenue (USD millions)	Operating Margin (%)	Market Share (Branded)
2018	150	35	65
2019	140	33	60
2020	135	30	58
2021	130	28	55

Future Projections

• Revenue decline expected in mature markets due to patent expiration and generic competition.
• Sales may stabilize or slightly increase in emerging markets with higher growth potential.
• Introduction of fixed-dose combinations and extended-release formulations could offset some revenue declines.

Profitability Trends

• Margins have compressed from 35% in 2018 to around 28% in 2021 due to increased competition.
• Cost reductions and efficiency improvements are critical for sustaining profitability.

How Will Market Trends Influence Future Financial Trajectory?

• Continued generic erosion in developed markets will pressure revenue.
• Growth in emerging markets and new formulation entries may partially offset declines.
• Potential regulatory changes favoring generics could further accelerate price competition.
• Patent protections for some formulations (e.g., extended-release versions) may sustain branded revenues until expiry.

Final Analysis

The market dynamics for CARDIZEM/diltiazem feature a transition from exclusivity to commoditization, influenced by patent expiries, regional growth opportunities, and competitive entry. Pfizer's revenue outlook indicates a downward trend in revenue from mature markets, with growth potential in emerging markets and new formulations compensating modestly. High competition and regulatory pressures are tightening margins, necessitating strategic adaptations such as portfolio diversification and innovation.

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Key Takeaways

1. The global calcium channel blocker market is growing at 4.8% CAGR, with Diltiazem holding a significant share.
2. Patent expiries have led to increased generic competition, reducing revenues in mature markets.
3. Emerging markets offer growth prospects due to healthcare investments and population aging.
4. Revenue is expected to decline in developed regions but stabilize or grow internationally.
5. Cost management and formulation innovation are essential for maintaining profitability.

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FAQs

1. When did Pfizer's patent for CARDIZEM expire?
Pfizer's U.S. patent for CARDIZEM expired in 2011, opening the market to generics.

2. How much of the current market is served by generic Diltiazem?
In North America and Europe, approximately 80-90% of sales are from generic formulations.

3. Which regulatory factors affect Diltiazem’s market?
Patents, bioequivalence requirements for generics, and regional drug approval processes influence market access.

4. What are the prospects for new formulations of Diltiazem?
Extended-release and fixed-dose combinations are gaining popularity, potentially stabilizing or increasing sales.

5. How does competitive pricing impact revenue?
Price erosion from generics reduces revenue margins; strategic pricing and patent protections are crucial for sustaining profitability.

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References

1. MarketsandMarkets. (2022). Calcium Channel Blockers Market.
2. Pfizer Inc. Annual Reports. (2018–2021).
3. IQVIA. (2022). Global Market Data.
4. European Medicines Agency. (2022). Regulatory Status of Diltiazem.
5. U.S. Food and Drug Administration. (2022). Patent and Exclusivity Information.