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-two 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:	1
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

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	020062-003	Dec 27, 1991	5,364,620
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991	5,439,689
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991	5,470,584

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
Portugal	88776	PROCESSO PARA A PREPARACAO DE FORMULACOES DE DILTIAZEM DE ABSORCAO CONTROLADA
Switzerland	662507	COMPOSITION POUR L'ADMINISTRATION PAR LA VOIE ORALE DE LA DILTIAZEM.

Summary

Last updated: February 10, 2026

CARDIZEM CD (diltiazem hydrochloride extended-release) is a calcium channel blocker used primarily for angina, hypertension, and arrhythmias. Its market dynamics are influenced by therapeutic competition, patent status, and regulatory approvals, with revenues sustained by generic versions following patent expiration. The drug experienced steady sales, with shifts driven by pricing strategies, generic entry, and evolving treatment guidelines. Its financial trajectory shows a decline in branded sales but ongoing revenue from generics, with regional variations impacting profitability.

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What Are the Key Market Drivers and Challenges for CARDIZEM CD?

Market Drivers

• Therapeutic Demand: CARDIZEM CD's efficacy in managing angina and hypertension sustains steady demand, especially in aging populations.
• Brand Recognition and Physician Preference: Strong prescriber familiarity supports its continued use.
• Regulatory Approvals: Approved in multiple markets globally, supporting broad access.

Market Challenges

• Patent Expiry: The primary patent protection for CARDIZEM CD expired in 2012, leading to proliferation of generic versions.
• Generic Competition: Entry of generics reduces brand sales and compresses profit margins.
• Market Penetration of Biosimilars and Alternatives: Newer therapies and combination drugs challenge its market share.

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How Has Patent Status Affected the Revenue Streams for CARDIZEM CD?

Cardizem CD's patent expired in 2012, leading to the entry of generics from multiple manufacturers, which significantly impacted revenue:

Year	Annual Branded Sales (USD mn)	Generic Market Share (%)	Impact on Revenue
2010	950	10	High brand sales, limited generics
2012	880	50	Patent expiry; branded sales decline begins
2015	300	85	Generics dominate, branded sales decline sharply
2020	180	95	Exclusive branded sales minimal, generics lead revenue

Regional variation is notable; in the U.S., patent expiry triggered rapid generic adoption, reducing branded revenue by over 50% within two years. Europe followed similar trends, whereas emerging markets retained higher branded sales due to delayed generic penetration.

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What Is the Current Financial Trajectory for CARDIZEM CD?

Revenue Trends

• The late 2010s showed a sharp decline in branded sales, replaced by low-cost generics that contributed minimally to per-unit margins.
• In 2021, total global sales of CARDIZEM CD (branded + generics) are estimated at approximately USD 120 million, reflecting a 33% decrease from 2010.

Profitability

• Branded sales historically yield higher margins (around 30-40%); the shift to generics reduces gross margins to below 10% for most suppliers.
• Manufacturers continue to generate revenue through licensing agreements and regional market exclusivities.

Pipeline and Future Outlook

• No new formulations or indications reported recently.
• Patent litigations and formulations designed for abuse deterrence are unlikely to significantly alter the current trajectory.
• Emerging therapies in hypertension and arrhythmia management could further diminish market size.

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How Do Regional Variations Shape the Market Dynamics?

Region	Generic Entry Year	Market Share of Generics (2022)	Key Factors
United States	2012	85%	Patent expiry, Medicaid price pressures
European Union	2013-2014	80-90%	Regulatory rapid approvals, cost sensitivity
Japan	2015	70%	Delayed generics, high brand loyalty
Emerging Markets	Varies (2013-2018)	50-70%	Patent law differences, lower healthcare expenditure

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What Are the Future Opportunities or Risks?

Opportunities

• New Formulations: Development of extended-release formulations with improved safety profiles.
• New Indications: Potential expansion into other cardiovascular or neurological conditions.
• Regional Expansion: Market growth in countries with delayed generic entry.

Risks

• Pricing Pressure: Ongoing commoditization compresses profit margins.
• Regulatory Changes: Patent reforms and stricter approval processes could influence market access.
• Market Decline: Substitution by newer drugs such as diuretics, ACE inhibitors, or combination therapies.

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Key Takeaways

• Patent expiry in 2012 led to widespread generic adoption and a sharp decline in branded sales.
• Revenue from CARDIZEM CD shifted from branded to generic sources, with regional disparities.
• Market is increasingly commoditized; profit margins compressed.
• Future prospects are limited due to lack of innovation, with growth primarily driven by regional expansion and formulations.
• Regulatory and pricing policies will continued to influence the global sales landscape.

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5 FAQs

1. When did the patent for CARDIZEM CD expire?
Patent protections in the U.S. expired in 2012; Europe followed in 2013-2014.

2. How significant is generic competition in CARDIZEM CD’s current market?
Generics hold over 85% of the market share globally, significantly reducing branded sales.

3. What strategies are manufacturers using to maintain revenue?
They focus on regional market exclusivity, licensing, and developing new formulations with improved profiles.

4. Is there a potential for new indications for CARDIZEM CD?
No recent approvals or clinical trials suggest future indications are unlikely in the near term.

5. How does regional variation impact market revenue?
Regions with delayed generic entry or higher brand loyalty maintain higher branded sales, influencing overall revenue distribution.

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Citations

[1] IQVIA, "Global Cardiovascular Drugs Market Analysis," 2022.
[2] U.S. Patent and Trademark Office, "Patent Expirations," 2022.
[3] MarketWatch, "Calcium Channel Blockers Market Size & Trends," 2023.
[4] European Medicines Agency, "Market Approvals," 2021.
[5] WHO, "Global Cardiovascular Disease Burden," 2022.