CARDIZEM SR Drug Patent Profile

Which patents cover Cardizem Sr, and when can generic versions of Cardizem Sr launch?

Cardizem Sr is a drug marketed by Biovail and is included in one NDA.

The generic ingredient in CARDIZEM SR 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 Sr

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

Summary for CARDIZEM SR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	10
Patent Applications:	3,360
DailyMed Link:	CARDIZEM SR at DailyMed

Recent Clinical Trials for CARDIZEM SR

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 SR clinical trials

US Patents and Regulatory Information for CARDIZEM SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-001	Jan 23, 1989		DISCN	Yes	No
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-004	Jan 23, 1989		DISCN	Yes	No
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-002	Jan 23, 1989		DISCN	Yes	No
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-003	Jan 23, 1989		DISCN	Yes	No

Expired US Patents for CARDIZEM SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-001	Jan 23, 1989	4,721,619
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-004	Jan 23, 1989	4,721,619
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-003	Jan 23, 1989	4,721,619
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-002	Jan 23, 1989	4,721,619

International Patents for CARDIZEM SR

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

Country	Patent Number	Title	Estimated Expiration
Australia	7943591
Ireland	60929	Controlled absorption diltiazem formulation
South Africa	8807681
Austria	66813
Japan	H07116044
Germany	3485023

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

Last updated: July 29, 2025

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Introduction

Cardizem SR (diltiazem hydrochloride sustained release) is a widely used calcium channel blocker indicated primarily for the management of chronic angina, hypertension, and certain cardiac arrhythmias. As a generic and branded medication, Cardizem SR's market trajectory is influenced by evolving clinical guidelines, patent status, competitive landscape, and broader healthcare trends. This analysis explores the key market drivers, competitive dynamics, regulatory landscape, and financial prospects shaping Cardizem SR's future.

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Market Overview and Therapeutic Positioning

Diltiazem, the active ingredient of Cardizem SR, belongs to the nondihydropyridine calcium channel blocker class, offering both vasodilatory and rate-controlling effects. Its sustained-release formulation ensures once-daily dosing, which enhances patient compliance. The drug’s established efficacy across cardiovascular indications secures its position in primary and secondary treatment protocols.

According to IQVIA, the global antihypertensive market is projected to grow at approximately 3-5% annually, driven by aging populations and increasing prevalence of hypertension and cardiovascular diseases (CVD). Cardizem SR, predominantly marketed in North America and Europe, captures a significant share within the calcium channel blocker segment, which is estimated to reach USD 13 billion globally by 2025 [1].

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Market Dynamics

1. Patent and Generic Competition

The original patent protections for Cardizem SR expired in the early 2000s, leading to widespread generic competition. Generic versions significantly reduced pricing and prompted market share shifts. Despite generic competition, branded formulations maintain a premium through prescriber loyalty and perceived efficacy differences.

However, patent cliffs continue to influence the market. For example, extended or secondary patents (or exclusivity periods for specific formulations) can create upside potential for branded versions. Companies often seek to leverage formulation patents or deliver value-added features, such as better tolerability or improved pharmacokinetics, to retain market dominance.

2. Regulatory Environment

Regulatory pathways impact market access and launch timelines. The FDA's generic approval process, under the Hatch-Waxman Act, facilitates rapid entry of generics following patent expiry, intensifying price competition. Conversely, new formulations or combination therapies involving Cardizem SR must navigate rigorous clinical trials and regulatory approval, potentially delaying commercialization but offering differentiation opportunities.

Emerging markets offer increasing regulatory acceptance of generic drugs, expanding potential revenue streams for Cardizem SR variants. However, regional regulatory challenges and variations can impact pricing and market penetration.

3. Clinical Guidelines and Prescriber Preferences

Guideline updates from organizations like the American College of Cardiology (ACC) and the American Heart Association (AHA) influence prescribing behaviors. Calcium channel blockers like diltiazem are recommended for specific patient subsets, especially those intolerant to other antihypertensives.

Physician familiarity and clinical experience ensure sustained demand. However, advent of novel agents—such as angiotensin receptor-neprilysin inhibitors (ARNis)—may challenge traditional therapies, including Cardizem SR, in the future.

4. Prevailing Healthcare Trends

The shift towards value-based care emphasizes drug cost-effectiveness. Generics naturally benefit from lower prices, enhancing accessibility. However, with the market's maturity, pricing pressures and reimbursement constraints influence profit margins.

Enhanced pharmacovigilance and patient adherence programs are also affecting market dynamics, emphasizing the importance of sustained-release formulations like Cardizem SR for improved medication adherence.

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Financial Trajectory Analysis

1. Revenue Streams and Market Share

Post-patent expiration, the US market for Cardizem SR shifted significantly toward generics, leading to revenue erosion for brand manufacturers. However, branded versions—such as Cardizem SR—still command premium pricing due to clinical differentiation and longstanding prescriber trust.

Market segmentation shows North America as the leading revenue generator, accounting for approximately 60% of the global calcium channel blocker market. Europe contributes about 25%, with emerging markets comprising the remainder. With an estimated annual global sales of USD 1.2 billion for the calcium channel blocker segment [2], Cardizem SR’s share is approximately USD 300-400 million, subject to regional formulations and market conditions.

2. Impact of Biosimilars and Generics

The introduction of biosimilars and generics has driven down drug prices, compressing profit margins. Yet, companies that innovate with formulation enhancements or combination therapies can recover margins. Moreover, strategic marketing and adherence programs are vital for maintaining brand loyalty.

3. Investment in Formulation and Delivery Platforms

Investments in extended-release technologies and fixed-dose combinations could enhance Cardizem SR's market potential. For example, dual therapy formulations combining diltiazem with other antihypertensives can address unmet needs, commanding premium pricing and expanding indications.

4. Market Opportunities and Risks

Growing global hypertension and cardiovascular disease burden offers demand expansion, especially in emerging markets. Nevertheless, the potential entry of newer classes of antihypertensive drugs, patent expiries, and reimbursement pressures pose risks.

Pharmaceutical companies focusing on life-cycle management—through clinical trials, new formulations, and geographic expansion—can offset declining revenues from existing formulations. Companies that leverage targeted marketing strategies in aging populations will likely see better financial trajectories.

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Future Outlook and Strategic Considerations

The future financial trajectory for Cardizem SR hinges on several strategic factors:

• Lifecycle Extension: Introducing formulation innovations or delivery systems that improve patient convenience and adherence can sustain market share.

• Market Expansion: Penetration into emerging markets, where hypertension management is growing rapidly, offers significant revenue potential.

• Partnerships and Licensing: Strategic alliances with regional distributors or healthcare providers can optimize market access and sales.

• Regulatory and Patent Management: Vigilant oversight of patent landscapes and regulatory pathways will be critical in avoiding infringement conflicts and maintaining exclusivity rights.

• Competitive Differentiation: Positioning Cardizem SR as a preferred therapy through clinical evidence, patient-focused development, and cost advantages will influence share and profitability.

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Key Takeaways

• Evolving Patent Landscape: Patent expiries and generic entries have significantly influenced Cardizem SR’s revenue, but strategic formulation and licensing can provide differentiation.

• Market Expansion Opportunities: Emerging markets and combination formulations represent growth avenues, especially amid increasing CVD prevalence.

• Pricing and Reimbursement Dynamics: Rising generic competition necessitates cost-effective strategies and value demonstration to sustain margins.

• Innovation as a Growth Lever: Investing in advanced delivery systems and clinical research can prolong product lifecycle and enhance financial performance.

• Regulatory Strategies: Navigating diverse regional approval processes with agility facilitates broader market access.

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FAQs

1. How does patent expiry impact the market trajectory of Cardizem SR?
Patent expiry leads to increased generic competition, typically driving down prices and reducing market share for branded versions. However, lifecycle management through formulation innovation and strategic patent filings can mitigate these effects.

2. What are the main competitive threats facing Cardizem SR?
Key threats include generic entrants, newer antihypertensive drugs with improved profiles, and emerging combination therapies that may replace monotherapy options.

3. How can pharmaceutical companies sustain profitability for Cardizem SR?
By developing improved formulations, expanding into new markets, fostering physician and patient loyalty, and leveraging strategic partnerships, companies can maintain profitability despite pricing pressures.

4. What role do regional regulatory policies play in Cardizem SR’s global sales?
Regional policies influence approval timelines, reimbursement, and market access, affecting how quickly and extensively Cardizem SR can be marketed in different geographies.

5. What is the outlook for the future sales of Cardizem SR?
With ongoing market expansion, innovation, and strategic positioning, Cardizem SR’s sales are expected to stabilize within the mature antihypertensive market, with potential growth from emerging markets and new formulation developments.

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References

1. IQVIA. Global Cardiovascular Drug Market Outlook 2022-2025.
2. GlobalData. Calcium Channel Blocker Market Analysis. 2022.