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Last Updated: April 1, 2025

CARDIZEM SR Drug Patent Profile


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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.

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Summary for CARDIZEM SR
Drug patent expirations by year for CARDIZEM SR
Recent Clinical Trials for CARDIZEM SR

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

SponsorPhase
Assiut UniversityEarly Phase 1
CAMC Health SystemPhase 4
University of South FloridaN/A

See all CARDIZEM SR clinical trials

US Patents and Regulatory Information for CARDIZEM SR

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-001 Jan 23, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-002 Jan 23, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-003 Jan 23, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-004 Jan 23, 1989 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for CARDIZEM SR

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-001 Jan 23, 1989 ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-002 Jan 23, 1989 ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-004 Jan 23, 1989 ⤷  Try for Free ⤷  Try for Free
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-003 Jan 23, 1989 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for CARDIZEM SR

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

CountryPatent NumberTitleEstimated Expiration
Australia 615221 ⤷  Try for Free
Austria 66813 ⤷  Try for Free
European Patent Office 0149920 PHARMACEUTICAL FORMULATION ⤷  Try for Free
Ireland 872790 ⤷  Try for Free
Japan H01132521 DILTIAZEM PREPARATION OF CONTROLLED ABSORPTION ⤷  Try for Free
South Africa 8807681 ⤷  Try for Free
Switzerland 662507 COMPOSITION POUR L'ADMINISTRATION PAR LA VOIE ORALE DE LA DILTIAZEM. ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory for CARDIZEM SR (Diltiazem)

Market Overview

The global diltiazem market, which includes CARDIZEM SR, is poised for significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this medication.

Market Size and Growth

The diltiazem market is projected to grow from US$ 369.95 million in 2021 to US$ 832.51 million by 2028, at a Compound Annual Growth Rate (CAGR) of 12.3% during the forecast period[1][3].

Market Drivers

Increase in Cardiovascular Disease Incidence

The rising incidence of cardiovascular diseases, such as hypertension, angina, and atrial fibrillation, is a major driver of the diltiazem market. Cardiovascular diseases are more prevalent among the elderly, and the increasing geriatric population globally is contributing to this trend[1][3].

Increasing Elderly Population

The elderly population is more prone to cardiovascular diseases due to factors like weak immunity, stiffening of the heart and blood vessels, and rising systolic blood pressure. This demographic shift is bolstering the demand for diltiazem[3].

Prevalence of Atrial Fibrillation

Diltiazem is effective for initial ventricular rate control in patients with atrial fibrillation, a condition whose prevalence is increasing globally. This effectiveness further drives the market growth[3].

Market Restraints

Side Effects of Diltiazem

Despite its therapeutic benefits, diltiazem is associated with several side effects, including dermatological, gastrointestinal, and cardiovascular issues. These side effects can hamper the market growth by reducing patient compliance and increasing the risk of adverse reactions[1][3][5].

Market Opportunities

Growth Opportunities in Developing Nations

Developing countries offer significant growth opportunities for the diltiazem market due to their large and growing populations, increasing healthcare expenditure, and improving access to healthcare services. Market players can leverage these opportunities to expand their market share[1][3].

Product Type Insights

The diltiazem market is segmented into capsules, injections, and tablets based on product type.

Tablets

In 2021, the tablets segment held the largest share of the market. However, the capsules segment is expected to witness the fastest CAGR during the forecast period, driven by the convenience and compliance associated with sustained-release formulations[1][3].

Capsules

The capsules segment, particularly the sustained-release (SR) formulations like CARDIZEM SR, is anticipated to grow rapidly. SR formulations are associated with better patient compliance and reduced healthcare expenditures, as they require less frequent dosing[2][3].

Injections

Diltiazem injections are used in acute settings, such as controlling heart rate in patients with atrial fibrillation. While this segment is crucial, it is expected to grow at a slower rate compared to capsules and tablets[1][3].

Application Insights

The diltiazem market is segmented into angina, hypertension, and other applications.

Hypertension

In 2021, the hypertension segment held the largest share of the market. Diltiazem is widely used to manage hypertension, especially in elderly patients, due to its efficacy in reducing blood pressure[1][3].

Angina

The angina segment is expected to grow at the fastest CAGR during the forecast period. Diltiazem helps in reducing the frequency of angina attacks and is often prescribed for chronic stable angina[1][3].

Geographic Analysis

The global diltiazem market is analyzed across various regions, including North America, Europe, Asia-Pacific, and the Middle East and Africa.

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the diltiazem market. While there were initial disruptions in supply chains and demand due to lockdowns, the market witnessed growth as diltiazem was seen to inhibit viral growth and related hypertension. Different regions experienced varying levels of impact, with some regions recovering faster than others[1].

Key Market Players

The diltiazem market is competitive, with several key players including Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer, Inc, Glenmark, Sandoz (Novartis Ag), Sun Pharmaceutical Company Ltd, Hikma Pharmaceuticals, and Zydus Pharmaceuticals[1][3].

Financial Benefits of Sustained-Release Formulations

Studies have shown that sustained-release formulations of diltiazem, such as CARDIZEM SR, can lead to significant economic benefits. For instance, a study in South Carolina's Medicaid program found that patients prescribed the SR formulation of diltiazem had a significant decrease in aggregate healthcare expenditures over a one-year period, primarily due to reduced hospital and physician services[2].

Future Trends

Recent Developments

The market is expected to see continued innovation in formulation technologies and delivery systems, which could enhance patient compliance and therapeutic outcomes. Recent developments in the market include the introduction of new dosage forms and the expansion of existing product lines by key market players[1].

Impact Analysis

The growth of the diltiazem market is influenced by various factors, including regulatory environments, technological advancements, and changes in healthcare policies. The market's future trajectory will be shaped by how these factors interact and evolve over time[1].

Key Takeaways

  • The global diltiazem market is projected to reach US$ 832.51 million by 2028, growing at a CAGR of 12.3%.
  • The increasing incidence of cardiovascular diseases and the growing elderly population are key drivers.
  • Sustained-release formulations like CARDIZEM SR are expected to drive market growth due to their convenience and economic benefits.
  • Side effects of diltiazem remain a significant restraint.
  • Developing nations offer significant growth opportunities.

FAQs

What is the projected market size of the diltiazem market by 2028?

The diltiazem market is projected to reach US$ 832.51 million by 2028[1][3].

What are the primary drivers of the diltiazem market?

The primary drivers include the increasing incidence of cardiovascular diseases and the growing elderly population[1][3].

Which product type segment is expected to grow the fastest in the diltiazem market?

The capsules segment, particularly sustained-release formulations, is expected to witness the fastest CAGR during the forecast period[1][3].

How has the COVID-19 pandemic impacted the diltiazem market?

The pandemic initially caused disruptions but ultimately led to market growth as diltiazem was seen to inhibit viral growth and related hypertension[1].

What are the economic benefits of sustained-release formulations of diltiazem?

Sustained-release formulations like CARDIZEM SR are associated with a significant decrease in aggregate healthcare expenditures due to reduced hospital and physician services[2].

Which companies are major players in the diltiazem market?

Key players include Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer, Inc, Glenmark, Sandoz (Novartis Ag), Sun Pharmaceutical Company Ltd, Hikma Pharmaceuticals, and Zydus Pharmaceuticals[1][3].

Sources

  1. Global Diltiazem Market (2021 to 2028) - Featuring Zydus Cadila, Glenmark, and Athenex Among Others. PR Newswire.
  2. Effect of pharmaceutical formulation for diltiazem on health care expenditures. PubMed.
  3. Diltiazem Market Size, Share & Growth Analysis by 2028. The Insight Partners.
  4. Cardizem CD 180 mg modified release capsules. Medsafe.
  5. CARDIZEM® (diltiazem hydrochloride) Tablets Rx only. FDA.

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