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-five 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:	5
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	10
Patent Applications:	4,315
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

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
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	AB3	RX	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	018602-004	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	018602-003	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
Sweden	337027
Netherlands	6815390
Switzerland	516587	Verfahren zur Herstellung von Benzothiazepinderivaten
Netherlands	141879
Germany	2226210
Germany	1643738	7-[3alpha,5alpha-Dihydroxy-2-(3-hydroxyoctenyl-(1))-cyclopentyl]-heptan-1-ol,dessen Tetraacetat und Verfahren zu deren Herstellung
United Kingdom	851827

CARDIZEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDIZEM (Diltiazem)

Introduction

CARDIZEM, or diltiazem, is a calcium channel blocker widely used in the treatment of hypertension, angina, and certain types of arrhythmias. The market for diltiazem is influenced by several key factors, including the increasing prevalence of cardiovascular diseases, the growing elderly population, and advancements in pharmaceutical technologies.

Market Size and Growth

The global diltiazem market is projected to experience significant growth, reaching US$ 832.51 million by 2028 from US$ 369.95 million in 2021, with a Compound Annual Growth Rate (CAGR) of 12.3% from 2021 to 2028[1][4].

Growth Drivers

Increase in Cardiovascular Disease Incidence

The rising incidence of cardiovascular diseases, such as hypertension, coronary artery disease, and heart failure, is a major driver of the diltiazem market. Cardiovascular diseases are more prevalent among the elderly, and the structural and functional changes in the cardiovascular system associated with aging contribute to this trend[1][4].

Growing Awareness of Diltiazem Benefits

Increasing awareness among healthcare providers and patients about the benefits of diltiazem in treating angina and arrhythmias is also driving market growth. Diltiazem's efficacy in reducing conduction in the atrioventricular node makes it particularly useful for heart rate control in patients with atrial fibrillation[4].

Increasing Geriatric Population

The global elderly population is expected to rise significantly, leading to a higher incidence of cardiovascular diseases and, consequently, an increased demand for diltiazem therapy. Elderly patients are more prone to atypical presentations, comorbid conditions, and unfavorable outcomes, further bolstering the market[1][4].

Market Restraints

Side Effects of Diltiazem

Despite its therapeutic benefits, diltiazem is associated with several side effects, such as dizziness, headache, and edema, which can hamper market growth. These side effects may lead to patient non-compliance and a preference for alternative treatments[1][4].

Future Trends

Development of Novel Delivery Systems

The development of novel delivery systems, such as extended-release formulations, is expected to improve patient compliance and outcomes. These formulations can provide more consistent drug levels, reducing the need for frequent dosing and enhancing patient adherence[1].

Personalized Medicine Approaches

There is an increasing focus on personalized medicine approaches to optimize diltiazem therapy based on individual patient profiles. This tailored approach can improve the efficacy and safety of the treatment, making it more appealing to both patients and healthcare providers[1].

Advancements in Telemedicine and Digital Health

Advancements in telemedicine and digital health technologies are facilitating remote monitoring of patients on diltiazem therapy. This can improve patient outcomes by enabling real-time monitoring and timely interventions, which is particularly beneficial for elderly patients who may have difficulty accessing healthcare facilities[1].

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 during the forecast period[1][4].

By Application

The market is also segmented by application into hypertension, angina, and others. The hypertension segment held the largest share in 2021, while the angina segment is expected to grow at the fastest CAGR in the coming years[1][4].

Regional Analysis

North America

The North America diltiazem market is expected to reach US$ 369.22 million by 2028 from US$ 161.53 million in 2021, growing at a CAGR of 12.5% from 2021 to 2028. This growth is driven by government initiatives, the increasing prevalence of cardiovascular diseases, and the rising elderly population[4].

Opportunities

Expansion of Generic Formulations

The expansion of generic formulations provides cost-effective alternatives to branded diltiazem products, which can increase market accessibility and drive growth. Generic formulations are particularly appealing in regions with limited healthcare budgets[1].

Potential for Combination Therapies

There is potential for combination therapies that incorporate diltiazem with other cardiovascular medications to enhance efficacy. Such combination therapies can offer better treatment outcomes and may attract more patients and healthcare providers[1].

Growth in Developing Regions

Improving healthcare infrastructure and rising access to essential medications in developing regions present significant opportunities for the diltiazem market. As these regions invest more in healthcare, the demand for cardiovascular treatments is expected to increase[1].

Key Players

The diltiazem market includes major players such as 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. These companies are focusing on product innovations and expanding their product portfolios to meet evolving customer demands[1].

Impact of COVID-19

The COVID-19 pandemic has had a substantial positive impact on the diltiazem market. The pandemic accelerated the development of vaccines and drugs, and various pharmaceutical companies have been working to combat the pandemic, which has indirectly boosted the demand for essential medications like diltiazem[4].

Financial Trajectory

The financial trajectory of the diltiazem market is promising, with significant growth projected over the next few years. Here are some key financial highlights:

• Global Market Size: Expected to reach US$ 832.51 million by 2028 from US$ 369.95 million in 2021[1].
• North America Market Size: Expected to reach US$ 369.22 million by 2028 from US$ 161.53 million in 2021[4].
• CAGR: 12.3% globally and 12.5% in North America from 2021 to 2028[1][4].

"The rising geriatric population worldwide is leading to an increase in the incidence of cardiovascular disease, bolstering the growth of the diltiazem market"[1].

Key Takeaways

• The diltiazem market is driven by the increasing incidence of cardiovascular diseases and the growing elderly population.
• The market is expected to grow significantly, with a global CAGR of 12.3% from 2021 to 2028.
• Novel delivery systems, personalized medicine approaches, and advancements in telemedicine are future trends that will shape the market.
• The expansion of generic formulations and potential for combination therapies offer additional growth opportunities.
• Key players are focusing on product innovations to maintain their market presence.

FAQs

What are the primary drivers of the diltiazem market?

The primary drivers of the diltiazem market include the increase in cardiovascular disease incidence, growing awareness of diltiazem benefits, and the increasing geriatric population.

What are the major segments of the diltiazem market?

The diltiazem market is segmented by product type into tablets, capsules, and injections, and by application into hypertension, angina, and others.

How is the COVID-19 pandemic impacting the diltiazem market?

The COVID-19 pandemic has had a positive impact on the diltiazem market by accelerating the development of essential medications and affecting the global supply chain positively.

What are the future trends in the diltiazem market?

Future trends include the development of novel delivery systems, increasing focus on personalized medicine approaches, and advancements in telemedicine and digital health technologies.

Which region is expected to show significant growth in the diltiazem market?

North America is expected to show significant growth, with the market projected to reach US$ 369.22 million by 2028 from US$ 161.53 million in 2021.

Sources

1. The Insight Partners, Diltiazem Market Size, Share & Growth Analysis by 2028.
2. Journal of the American College of Cardiology, 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.
3. American Heart Association, Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
4. Business Market Insights, Diltiazem Market in North America report 2028.
5. American Heart Association, 2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia.