cardizem la Drug Patent Profile

Which patents cover Cardizem La, and what generic alternatives are available?

Cardizem La is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardizem La

A generic version of cardizem la was approved as diltiazem hydrochloride by TEVA on May 31^st, 1995.

Summary for cardizem la

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 la
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cardizem la
What excipients (inactive ingredients) are in cardizem la?	cardizem la excipients list
DailyMed Link:	cardizem la at DailyMed

See drug prices for cardizem la

See drug sales revenues for cardizem la

Recent Clinical Trials for cardizem la

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 la clinical trials

Pharmacology for cardizem la

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Paragraph IV (Patent) Challenges for CARDIZEM LA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	120 mg, 180 mg, 240 mg, 300 mg and 360 mg	021392	1	2005-08-30
CARDIZEM LA	Extended-release Tablets	diltiazem hydrochloride	420 mg	021392	1	2005-04-25

US Patents and Regulatory Information for cardizem la

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-001	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-002	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	AB	RX	Yes	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003	AB	RX	Yes	Yes
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003	AB	RX	Yes	No

Expired US Patents for cardizem la

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	6,923,984
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003	6,923,984
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-001	Feb 6, 2003	5,288,505
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	5,529,791
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	5,288,505
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	5,288,505

International Patents for cardizem la

See the table below for patents covering cardizem la around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0591424	DILTIAZEM SE PRESENTANT SOUS UNE FORME A LIBERATION PROLONGEE (EXTENDED-RELEASE FORM OF DILTIAZEM)
Canada	2292247
Australia	6566700
World Intellectual Property Organization (WIPO)	9300093
Austria	184196
Germany	69229949

Cardizem la Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for CARDIZEM LA

Introduction to CARDIZEM LA

CARDIZEM LA, a long-acting formulation of diltiazem hydrochloride, is a calcium channel blocker developed by Biovail (now part of Bausch Health Companies Inc.). It is designed to provide 24-hour antianginal and antihypertensive control, making it a significant player in the treatment of chronic stable angina and hypertension[3].

Market Drivers

Increase in Cardiovascular Disease Incidence

The rise in cardiovascular diseases, particularly among the elderly population, is a major driver for the diltiazem market. Heart diseases such as coronary artery disease, heart failure, and hypertension are more prevalent in older adults due to factors like weak immunity, stiffening of heart and blood vessels, and increased systolic blood pressure. This trend is expected to continue, bolstering the demand for diltiazem formulations like CARDIZEM LA[1][4].

Increasing Elderly Population

The global elderly population is projected to increase significantly, with estimates suggesting a substantial rise by 2100. This demographic shift is crucial because elderly individuals are more prone to cardiovascular diseases, atypical presentations, comorbid conditions, and unfavorable outcomes. As a result, the growing geriatric population drives the demand for cardiovascular treatments, including CARDIZEM LA[4].

Government Initiatives and Promotions

Government initiatives aimed at promoting healthcare and managing cardiovascular diseases also contribute to the market growth. These initiatives often include awareness campaigns, subsidies for medications, and investments in healthcare infrastructure, all of which can increase the adoption of diltiazem-based treatments[1].

Market Restraints

Side Effects of Diltiazem

Despite its therapeutic benefits, diltiazem is associated with several side effects that can hamper market growth. These include potential interactions with other medications, contraindications in patients with certain conditions (such as sick sinus syndrome or second- or third-degree atrioventricular block), and precautions needed for patients with impaired hepatic or renal function. These factors can limit the prescription and use of CARDIZEM LA[1][3][4].

Market Segmentation

By Product Type

The diltiazem market, including CARDIZEM LA, is segmented into capsules, injections, and tablets. In 2021, the tablets segment held the largest share of the market, but the capsules segment is expected to witness the fastest CAGR from 2021 to 2028. CARDIZEM LA, being a long-acting tablet formulation, falls under this category and benefits from the growing demand for tablet forms[1][4].

By Application

The market is also segmented by application, with hypertension and angina being the primary uses. In 2021, the hypertension segment held the largest share, while the angina segment is expected to grow at the fastest CAGR during the forecast period. CARDIZEM LA's approval for both hypertension and angina treatment positions it well in these growing segments[1][4].

Financial Trajectory

Market Size and Growth

The North America diltiazem market, which includes CARDIZEM LA, is projected to grow significantly. From US$ 161.53 million in 2021, the market is expected to reach US$ 369.22 million by 2028, growing at a CAGR of 12.5% from 2021 to 2028. This growth is driven by the increasing incidence of cardiovascular diseases and the rising elderly population[1].

Revenue Forecast by Product Type

The tablets segment, where CARDIZEM LA is categorized, held the largest market share in 2021. However, the capsules segment is expected to grow at the fastest rate, with a CAGR of 12.8% from 2021 to 2028. This indicates a potential shift in market dynamics that could influence the financial performance of CARDIZEM LA and similar products[1][4].

Impact of COVID-19

The COVID-19 pandemic has had a substantial positive impact on the diltiazem market. The increased focus on healthcare and the development of vaccines and drugs to combat the pandemic have boosted the demand for cardiovascular treatments. This trend is expected to continue, supporting the financial trajectory of CARDIZEM LA[1].

Recent Developments and Strategies

Clinical Experience Programs

Biovail initiated a Clinical Experience Program called “PLACE” to better evaluate the performance of CARDIZEM LA in clinical settings. Such programs help in gathering real-world data, improving patient outcomes, and enhancing the market position of the drug[5].

Competitive Landscape

The diltiazem market is competitive, with major players including Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer, Inc, and others. Bausch Health, the parent company of Biovail, continues to invest in research and development, marketing, and strategic partnerships to maintain its market share and drive growth for CARDIZEM LA[1][4].

Key Takeaways

• The diltiazem market, driven by the rise in cardiovascular diseases and the increasing elderly population, is expected to grow significantly.
• CARDIZEM LA, as a long-acting tablet formulation, benefits from the growing demand for tablets and its approval for treating hypertension and angina.
• Despite side effects and potential interactions, the market is expected to grow at a CAGR of 12.5% from 2021 to 2028.
• The COVID-19 pandemic has positively impacted the market, and ongoing clinical experience programs and strategic initiatives by Bausch Health are expected to support the financial trajectory of CARDIZEM LA.

FAQs

1. What is CARDIZEM LA, and how does it work?

CARDIZEM LA is a long-acting formulation of diltiazem hydrochloride, a calcium channel blocker. It works by inhibiting the calcium ion influx during membrane depolarization in cardiac and smooth muscle, leading to a decrease in heart rate and systemic blood pressure.

2. What are the primary applications of CARDIZEM LA?

CARDIZEM LA is primarily used for the treatment of hypertension and chronic stable angina.

3. What are the key drivers of the diltiazem market?

The key drivers include the increase in cardiovascular disease incidence and the rising elderly population.

4. What are the potential side effects and contraindications of CARDIZEM LA?

CARDIZEM LA has potential side effects and interactions, and it is contraindicated in patients with certain conditions such as sick sinus syndrome or second- or third-degree atrioventricular block.

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

The COVID-19 pandemic has had a substantial positive impact on the diltiazem market by increasing the focus on healthcare and boosting the demand for cardiovascular treatments.

Cited Sources:

1. Business Market Insights: North America Diltiazem Market report 2028.
2. Bausch Health: Biovail Reports Third-Quarter 2009 Financial Results.
3. Pharmacy Times: Profile: Cardizem LA (diltiazem hydrochloride).
4. The Insight Partners: Diltiazem Market Size, Share & Growth Analysis by 2028.
5. Biovail Corporation: Second Quarter Report 2003.