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-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 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:	3
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	10
Patent Applications:	3,033
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
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991	AB3	RX	Yes	No
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-005	Aug 24, 1999	AB3	RX	Yes	Yes

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	020062-004	Dec 27, 1991	5,470,584
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-002	Dec 27, 1991	5,364,620
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991	5,439,689
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991	5,364,620
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-005	Aug 24, 1999	5,286,497

International Patents for CARDIZEM CD

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0149920	PHARMACEUTICAL FORMULATION
South Africa	9203474
Australia	653223
Austria	147982
Australia	615221

CARDIZEM CD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CARDIZEM CD

Introduction

CARDIZEM CD, a formulation of diltiazem hydrochloride, is a crucial medication for treating hypertension, angina, and certain heart conditions. Understanding its market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, healthcare providers, and patients.

Market Drivers

Increase in Cardiovascular Disease Incidence

The rising prevalence of cardiovascular diseases, such as hypertension and angina, is a significant driver for the diltiazem market. As the global population ages, the incidence of these conditions increases, leading to a higher demand for effective treatments like CARDIZEM CD[3].

Increasing Elderly Population

The elderly population is more prone to cardiovascular diseases, and the growing number of older individuals worldwide is expected to boost the demand for diltiazem. This demographic shift is a key factor in the market's growth[3].

Market Restraints

Side Effects of Diltiazem

Despite its efficacy, diltiazem can have side effects, particularly in patients with preexisting ventricular function impairment. These side effects can include increased heart failure and other cardiovascular complications, which may negatively impact market growth[4].

Financial Performance and Revenue Forecast

Historical Revenue

In the late 1990s, CARDIZEM CD was a highly lucrative drug for Hoechst, earning over $700 million in 1997 alone. This revenue was significantly influenced by the company's efforts to prevent generic alternatives from entering the market[2].

Current Market Size and Growth

The North America diltiazem market, which includes CARDIZEM CD, is projected to grow from $161.53 million in 2021 to $369.22 million by 2028, at a Compound Annual Growth Rate (CAGR) of 12.5%. This growth is driven by increasing government initiatives, the rising prevalence of cardiovascular diseases, and the growing elderly population[3].

Market Segmentation

Product Type

The diltiazem market is segmented into capsules, injections, and tablets. While tablets held the largest share in 2021, the capsules segment, which includes CARDIZEM CD, is expected to witness the fastest CAGR from 2021 to 2028[3].

Application

The market is also segmented by application, with hypertension being the largest segment in 2021. However, the angina segment is expected to grow at the fastest CAGR in the coming years[3].

Impact of Antitrust and Consumer Protection Issues

Historical Antitrust Issues

In the past, CARDIZEM CD's market dominance was maintained through anticompetitive practices. Hoechst and Andrx conspired to prevent the entry of generic alternatives, leading to artificially high prices and significant financial gains for Hoechst. This practice was challenged in court, highlighting the importance of fair market competition[2].

Supply Chain and Market Access

Recent Supply Chain Changes

In New Zealand, the supply of diltiazem hydrochloride capsules has undergone changes. The Apo-Diltiazem CD brand was delisted from the Pharmaceutical Schedule, and the Cardizem CD brand became the only funded brand of 180 mg and 240 mg diltiazem hydrochloride capsules from February 2022. This change ensures a stable supply of the medication but also highlights the complexities of pharmaceutical supply chains[1].

Pharmacological and Clinical Impact

Mechanism of Action

CARDIZEM CD works by decreasing vascular resistance, increasing cardiac output, and slightly reducing heart rate. It is effective in lowering blood pressure and managing angina, making it a valuable treatment option for patients with cardiovascular conditions[4].

Future Trends and Developments

Recent Developments and Market Growth

The COVID-19 pandemic has had a positive impact on the diltiazem market, with increased focus on healthcare and pharmaceuticals. Future trends include the development of new formulations and the expansion of market access through government initiatives and increased awareness of cardiovascular health[3].

Key Takeaways

• The diltiazem market, including CARDIZEM CD, is driven by the increasing incidence of cardiovascular diseases and the growing elderly population.
• The market is expected to grow significantly, reaching $369.22 million by 2028.
• Historical antitrust issues have impacted the market, but current trends focus on fair competition and expanded market access.
• The pharmacological efficacy of CARDIZEM CD makes it a crucial treatment option for hypertension and angina.

Frequently Asked Questions (FAQs)

Q: What is CARDIZEM CD used for? A: CARDIZEM CD is used for the treatment of hypertension, angina, and certain heart conditions.

Q: Why is the diltiazem market growing? A: The market is growing due to the increasing incidence of cardiovascular diseases and the growing elderly population.

Q: What was the impact of antitrust issues on CARDIZEM CD? A: Antitrust issues led to artificially high prices and prevented the entry of generic alternatives, affecting consumer access and healthcare costs.

Q: How has the supply chain for diltiazem hydrochloride changed in New Zealand? A: The Apo-Diltiazem CD brand was delisted, and the Cardizem CD brand became the only funded brand of 180 mg and 240 mg diltiazem hydrochloride capsules from February 2022.

Q: What are the future trends for the diltiazem market? A: Future trends include the development of new formulations, expanded market access, and increased focus on cardiovascular health driven by government initiatives and the COVID-19 pandemic.

Cited Sources

1. Pharmac.govt.nz: Decision to secure supply of 180 mg and 240 mg diltiazem hydrochloride capsules.
2. Maine.gov: AG Rowe files suit against drug manufacturers for keeping generic alternatives off the market.
3. Business Market Insights: North America Diltiazem Market report 2028.
4. Accessdata.fda.gov: Cardizem CD (diltiazem hydrochloride) capsule label.