You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 10, 2025

Diltiazem malate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for diltiazem malate and what is the scope of patent protection?

Diltiazem malate is the generic ingredient in two branded drugs marketed by Merck and Biovail, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for diltiazem malate.

Summary for diltiazem malate

US Patents and Regulatory Information for diltiazem malate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-003 Oct 4, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-001 Oct 4, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-002 Oct 4, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for diltiazem malate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-001 Oct 4, 1996 4,880,631 ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-002 Oct 4, 1996 4,968,507 ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-001 Oct 4, 1996 4,968,507 ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-003 Oct 4, 1996 4,880,631 ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-003 Oct 4, 1996 4,968,507 ⤷  Subscribe
Merck TIAMATE diltiazem malate TABLET, EXTENDED RELEASE;ORAL 020506-002 Oct 4, 1996 4,880,631 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Diltiazem malate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Diltiazem Malate

Introduction to Diltiazem Malate

Diltiazem malate, a malate salt of diltiazem, is a benzothiazepine calcium channel blocking agent used primarily to treat high blood pressure, angina, and certain heart rhythm disorders. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth Projections

The global diltiazem market is anticipated to experience significant growth over the coming years. By 2028, the market is projected to reach US$ 832.51 million from US$ 369.95 million in 2021, growing at a Compound Annual Growth Rate (CAGR) of 12.3% from 2021 to 2028[1][3].

Regional Insights

The market is segmented geographically into North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America. The North America diltiazem market, for instance, is expected to grow from US$ 161.53 million in 2021 to US$ 369.22 million by 2028, with a CAGR of 12.5% during this period[3].

Driving Factors

Increase in Cardiovascular Diseases

The rising incidence of cardiovascular diseases, particularly among the elderly population, is a major driver of the diltiazem market. As people age, they are more prone to heart conditions such as hypertension, coronary artery disease, and heart failure, which necessitate the use of medications like diltiazem[1].

Aging Population

The global elderly population is increasing, and this demographic shift is expected to continue, with significant implications for the healthcare sector. By 2100, the elderly population is projected to reach 3.1 billion, further bolstering the demand for diltiazem and other cardiovascular medications[1].

Government Initiatives and Awareness

Government initiatives aimed at promoting healthcare and increasing awareness about cardiovascular diseases also contribute to the market growth. These initiatives often include public health campaigns and policies that encourage the use of effective medications like diltiazem[3].

Market Segmentation

By Product Type

The diltiazem market is segmented into tablets, capsules, and injections. In 2021, the tablets segment held the largest share of the market, while the capsules segment is expected to witness the fastest CAGR of 12.8% during the forecast period[1][3].

By Application

The market is also segmented by application into hypertension, angina, and others. The hypertension segment dominated the market in 2021, while the angina segment is expected to grow at the fastest CAGR in the coming years[1][3].

Impact of COVID-19

The COVID-19 pandemic has had a positive impact on the diltiazem market. The pandemic accelerated the development and distribution of various pharmaceutical products, including those for cardiovascular diseases. This has led to increased demand and production of diltiazem, contributing to market growth[3].

Economic Utility and Compliance

Studies have shown that the sustained-release (SR) formulation of diltiazem can significantly reduce aggregate healthcare expenditures. For instance, a study in South Carolina's Medicaid program found that patients prescribed the SR formulation of diltiazem had higher medication compliance and lower overall healthcare costs compared to those on the immediate-release (IR) formulation[2].

Side Effects and Challenges

Despite the growth prospects, the diltiazem market faces challenges due to the side effects associated with the medication. These side effects can hamper market growth as they may lead to reduced patient compliance and increased healthcare costs related to managing these adverse effects[1][3].

Key Market Players

The diltiazem market is characterized by a significant presence of major pharmaceutical companies. 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 among others. These companies are focusing on product innovations and expanding their offerings to meet evolving customer demands[1].

Financial Impact on Healthcare

The use of diltiazem, particularly in its SR formulation, can have a positive financial impact on healthcare systems. By reducing the need for frequent dosing, SR formulations can increase patient compliance and decrease overall healthcare expenditures, including costs associated with physician visits, hospital stays, and laboratory services[2].

Future Trends and Innovations

The market is expected to see continued innovation, with companies focusing on developing more effective and patient-friendly formulations. Research into new applications of diltiazem, such as in the treatment of cluster headaches and reduction of cocaine cravings, may also expand the market scope[4].

Key Takeaways

  • The global diltiazem market is projected to grow significantly, driven by increasing cardiovascular disease incidence and an aging population.
  • The North America market is expected to reach US$ 369.22 million by 2028, growing at a CAGR of 12.5%.
  • The tablets segment currently dominates the market, but the capsules segment is expected to grow at the fastest CAGR.
  • Hypertension is the largest application segment, with angina expected to grow rapidly.
  • Side effects of diltiazem may hamper market growth despite overall positive trends.
  • Major pharmaceutical companies are driving innovation and market expansion.

FAQs

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

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

Q: 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].

Q: Which segment holds the largest share in the diltiazem market by product type?

The tablets segment currently holds the largest share in the diltiazem market by product type[1][3].

Q: How does the sustained-release formulation of diltiazem impact healthcare costs?

The sustained-release formulation of diltiazem is associated with a significant decrease in aggregate healthcare expenditures due to increased patient compliance and reduced need for frequent dosing[2].

Q: Which companies are major players in the diltiazem market?

Major players include Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer, Inc, and others[1].

Sources

  1. The Insight Partners: Diltiazem Market Size, Share & Growth Analysis by 2028.
  2. PubMed: Effect of pharmaceutical formulation for diltiazem on health care expenditures.
  3. Business Market Insights: Diltiazem Market in North America report 2028.
  4. Wikipedia: Diltiazem.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.