DILTIAZEM HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for diltiazem hydrochloride and what is the scope of freedom to operate?

Diltiazem hydrochloride is the generic ingredient in twelve branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Alembic, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Exela Pharma, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in sixty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for diltiazem hydrochloride. Fifty-five suppliers are listed for this compound.

Summary for DILTIAZEM HYDROCHLORIDE

US Patents:	0
Tradenames:	12
Applicants:	40
NDAs:	63
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	106
Patent Applications:	4,739
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILTIAZEM HYDROCHLORIDE
What excipients (inactive ingredients) are in DILTIAZEM HYDROCHLORIDE?	DILTIAZEM HYDROCHLORIDE excipients list
DailyMed Link:	DILTIAZEM HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE

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

Sponsor	Phase
Ascension Genesys Hospital	Phase 2
Aurora Health Care	Phase 4
Hospices Civils de Lyon	Phase 2

See all DILTIAZEM HYDROCHLORIDE clinical trials

Pharmacology for DILTIAZEM HYDROCHLORIDE

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DILTIAZEM HYDROCHLORIDE

C05AE	Muscle relaxants
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

C08DB	Benzothiazepine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE

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 DILTIAZEM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	074067-001	Nov 5, 1992		DISCN	No	No
Apotex	DILTZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	076395-005	Feb 1, 2006		DISCN	No	No
Sciegen Pharms Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216327-001	Apr 6, 2023	AB	RX	No	No

Expired US Patents for DILTIAZEM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-006	Feb 6, 2003
Biovail	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020939-004	Jan 28, 2000
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-004	Dec 27, 1991

DILTIAZEM HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diltiazem Hydrochloride

Introduction

Diltiazem hydrochloride, a calcium channel blocker, is widely used to manage hypertension, angina pectoris, and certain heart rhythm disorders. The market for this drug is influenced by several key factors, including demographic changes, healthcare policies, and advancements in pharmaceutical technology.

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% during this period[1].

In North America, the market is expected to grow from US$ 161.53 million in 2021 to US$ 369.22 million by 2028, at a CAGR of 12.5%[3].

Segmentation

The diltiazem market is segmented based on product type and application.

Product Type

• The tablets segment held the largest share of the market in 2021, but the capsules segment is expected to witness the fastest CAGR from 2021 to 2028[1][3].
• Other product forms include injections, which are also gaining traction, particularly in hospital and clinical settings[4].

Application

• The hypertension segment held the largest share of the market in 2021, while the angina segment is expected to grow at the fastest CAGR during the coming years[1][3].

Market Drivers

Several factors are driving the growth of the diltiazem hydrochloride market:

Rising Prevalence of Cardiovascular Diseases

The increasing incidence of cardiovascular diseases, such as hypertension and angina, is a significant driver. As the global population ages, the demand for effective cardiovascular treatments is on the rise[3][4].

Government Initiatives and Funding

Government initiatives to promote cardiovascular health and increase funding in this sector are boosting the market. These initiatives include public health campaigns and subsidies for cardiovascular medications[4].

Availability of Generic Formulations

The availability of generic formulations of diltiazem hydrochloride has increased access and affordability, contributing to market growth[4].

Impact of COVID-19

The COVID-19 pandemic has had a positive impact on the diltiazem market. The increased stress on healthcare systems and the need for effective treatments for hypertension and related conditions have driven demand for diltiazem[1][3].

Market Restraints

Despite the growth drivers, there are several challenges that could impact the market:

Side Effects

The side effects associated with diltiazem consumption, such as dermatological events and potential hepatic damage, could negatively impact market growth[2].

Regulatory and Quality Control Issues

Stringent quality control standards and regulatory barriers can affect the production and distribution of diltiazem hydrochloride. Ensuring compliance with these standards is crucial to avoid recalls and safety concerns[4].

Supply Chain Disruptions

Supply chain disruptions, particularly during the COVID-19 pandemic, have affected the availability of diltiazem. However, the market has shown resilience and adaptability in response to these challenges[1].

Market Opportunities

There are several opportunities for growth and expansion in the diltiazem hydrochloride market:

Emerging Markets

Emerging markets with inadequate healthcare infrastructure present significant opportunities for the adoption of diltiazem hydrochloride. These regions have a growing need for effective cardiovascular treatments[4].

Advancements in Drug Delivery Systems

Research and development in novel drug delivery systems, such as sustained-release formulations, can enhance patient compliance and comfort. These advancements are expected to drive market growth[4].

Geographic Analysis

The market for diltiazem hydrochloride varies across different regions:

North America

The North American market is expected to reach US$ 369.22 million by 2028, driven by government initiatives and the rising prevalence of cardiovascular diseases[3].

Europe

Europe has been significantly affected by COVID-19, leading to increased demand for diltiazem. Countries like the UK, Germany, France, Spain, and Italy are key markets in this region[1].

Asia Pacific

The Asia Pacific region is also experiencing rapid growth, driven by the increasing incidence of cardiovascular diseases and advancements in healthcare infrastructure[1].

Middle East and Africa

This region is seeing growth due to the rising prevalence of cardiovascular diseases and government initiatives to improve healthcare access[1].

Competitive Landscape

The competitive landscape of the diltiazem hydrochloride market is characterized by:

Market Share and Strategic Approaches

Leading market players are focusing on strategic approaches such as product diversification, geographic expansion, and investments in research and development. These strategies help in maintaining market share and driving growth[4].

Product Innovation

Companies are investing in the development of new and improved formulations, such as sustained-release capsules and injections, to enhance patient compliance and reduce side effects[4].

Financial Trajectory

The financial trajectory of the diltiazem hydrochloride market is positive, with significant growth projected over the next few years.

Revenue Forecast

The global market is expected to reach US$ 832.51 million by 2028, with regional markets such as North America and Europe contributing substantially to this growth[1][3].

Investment Opportunities

The market offers several investment opportunities, particularly in research and development, and in expanding into emerging markets. These investments can help companies capitalize on future growth opportunities[4].

Key Takeaways

• The global diltiazem hydrochloride market is expected to grow significantly, driven by the rising prevalence of cardiovascular diseases and government initiatives.
• The market is segmented into tablets, capsules, and injections, with the capsules segment expected to grow the fastest.
• Emerging markets and advancements in drug delivery systems present key opportunities for growth.
• Side effects and regulatory issues are potential restraints that need to be addressed.
• The financial trajectory is positive, with substantial revenue growth projected over the next few years.

FAQs

Q: What is the projected global market size for diltiazem hydrochloride by 2028? A: The global diltiazem market is projected to reach US$ 832.51 million by 2028[1].

Q: Which segment is expected to grow the fastest in the diltiazem hydrochloride market? A: The capsules segment is expected to witness the fastest CAGR from 2021 to 2028[1][3].

Q: How has the COVID-19 pandemic impacted the diltiazem hydrochloride market? A: The COVID-19 pandemic has had a positive impact on the market due to increased demand for hypertension treatments and the strain on healthcare systems[1][3].

Q: What are the main drivers of the diltiazem hydrochloride market? A: The main drivers include the rising prevalence of cardiovascular diseases, government initiatives, and the availability of generic formulations[3][4].

Q: What are the potential restraints on the diltiazem hydrochloride market? A: Potential restraints include side effects, regulatory and quality control issues, and supply chain disruptions[2][4].

Cited Sources:

1. Global Diltiazem Market Forecast to 2028 - COVID-19 Impact and ... - ResearchAndMarkets
2. CARDIZEM® (diltiazem hydrochloride) Direct Compression Tablets ... - FDA
3. Diltiazem Market in North America report 2028 - BusinessMarketInsights
4. Injection Diltiazem Hydrochloride Market Size 2025-2030 - 360iResearch
5. Diltiazem: Uses, Interactions, Mechanism of Action | DrugBank Online - DrugBank