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 thirteen branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Ph Health, Pharmobedient, 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, Hq Spclt Pharma, Exela Pharma, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, and Zydus Lifesciences, and is included in sixty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for DILTIAZEM HYDROCHLORIDE

US Patents:	0
Tradenames:	13
Applicants:	42
NDAs:	68
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	117
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
Second Affiliated Hospital, School of Medicine, Zhejiang University	PHASE4
Anne E. Zepeski	PHASE4
Oman Medical Speciality Board	PHASE3

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
Actavis Labs Fl Inc	TAZTIA XT	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	075401-002	Apr 10, 2003		DISCN	No	No
Chartwell Rx	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	091022-004	Sep 28, 2012	AB4	RX	No	No
Sun Pharm	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203023-004	Jun 8, 2017		DISCN	No	No
Sciegen Pharms Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	216521-003	Sep 23, 2022	AB	RX	No	No

Expired US Patents for DILTIAZEM HYDROCHLORIDE

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
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-002	Feb 6, 2003
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003

Market Dynamics and Financial Trajectory for Diltiazem Hydrochloride

Last updated: July 27, 2025

Introduction

Diltiazem hydrochloride, a calcium channel blocker, plays a pivotal role in managing hypertension, angina pectoris, and certain cardiac arrhythmias. As a cornerstone in cardiovascular therapy, its market landscape is shaped by evolving medical guidelines, patent statuses, manufacturing trends, and competitive forces. This analysis explores the current market dynamics and projects the financial trajectory for diltiazem hydrochloride, offering vital insights for industry stakeholders, investors, and healthcare providers.

Market Overview and Therapeutic Significance

Diltiazem hydrochloride is positioned within the broader cardiovascular therapeutics segment, which has exhibited steady growth owing to increasing prevalence of hypertension and ischemic heart diseases globally. According to the World Health Organization (WHO), cardiovascular diseases remain the leading cause of mortality, underpinning sustained demand for effective antihypertensive and anti-anginal agents like diltiazem. In 2022, the global cardiovascular drugs market was valued at approximately $120 billion, with calcium channel blockers comprising a significant share [1].

Diltiazem is available in various formulations—immediate-release tablets, sustained-release formulations, injectables—which influence market segmentation and revenue streams. Its efficacy, favorable side effect profile, and versatility bolster its longstanding clinical use.

Market Drivers

Rising Prevalence of Cardiovascular Diseases

The global burden of hypertension is projected to reach 1.6 billion people by 2025, fueling demand for antihypertensives such as diltiazem [2]. Aging populations, sedentary lifestyles, and dietary factors exacerbate this trend. Consequently, pharmaceutical companies continue to prioritize cardiovascular agents, with diltiazem maintaining relevance due to its proven efficacy.

Clinical Guideline Endorsements

Updated clinical guidelines from the American Heart Association (AHA), European Society of Cardiology (ESC), and other bodies underscore the role of calcium channel blockers, including diltiazem, as first-line or adjunct therapy for hypertension and angina. This fortifies market stability and influences prescribing practices.

Formulation Innovation and Indications Expansion

Development of sustained-release formulations has enhanced patient compliance and expanded indications, such as in arrhythmia management. The pharmaceutical sector's investment in formulation research sustains market growth opportunities.

Regulatory Environment

Patents for original diltiazem formulations have largely expired or are nearing expiry, prompting a shift towards generic manufacturing. The entry of generics drives price competition but also ensures widespread access, thereby expanding the market.

Market Challenges and Constraints

Generic Competition and Price Erosion

The expiration of patents for several diltiazem formulations has intensified generic competition, leading to significant price declines. As generics typically sell at a fraction of brand-name prices, profit margins shrink, impacting revenue streams for original developers.

Market Saturation in Mature Economies

In developed markets, the penetration of diltiazem-based therapies is approaching saturation, prompting companies to seek growth via emerging markets. Additionally, the presence of newer drug classes, such as direct renin inhibitors, introduces substitution risks.

Regulatory and Quality Concerns

Stringent regulatory oversight, especially concerning bioequivalence standards and manufacturing quality, influences market entry and product proliferation. Non-compliance can lead to recalls or market bans, affecting financial stability.

Emerging Therapeutics and Competition

Novel antihypertensive agents with improved safety profiles or targeted mechanisms pose competition. For instance, combination therapies involving ACE inhibitors or ARBs may reduce reliance on calcium channel blockers.

Market Segmentation and Geographic Trends

Regional Insights

• North America: Dominates due to high prevalence of hypertension, advanced healthcare infrastructure, and high drug awareness. The market here is mature with steady generic sales.
• Europe: Similar to North America, with stringent regulations favoring quality and patent protections.
• Asia-Pacific: Exhibiting the highest growth potential driven by increasing cardiovascular disease incidence, expanding healthcare access, and government initiatives promoting affordable generics [3].

Formulation Preferences

Sustained-release formulations predominate in developed markets to improve adherence, whereas immediate-release variants maintain significant demand, especially in emerging economies.

Financial Trajectory and Forecast

Historical Performance Analysis

Over the past decade, the global diltiazem market experienced moderate growth, paralleling the CAGR of the cardiovascular drugs industry (~4-6%). The patent expiries from 2010 onwards precipitated a shift towards generics, stabilizing revenues for original manufacturers but expanding affordability and market reach globally.

Projected Growth and Revenue Streams

• Market Size Forecasts: The diltiazem segment is projected to grow at a CAGR of approximately 3-4% from 2023 to 2030, driven primarily by emerging markets and formulation innovations [4].
• Revenue Contributions: Generics are expected to dominate sales, capturing over 80% of the market share, with branded formulations maintaining premium pricing niches in critical markets.
• Emerging Opportunities: Development of combination drugs incorporating diltiazem (e.g., fixed-dose combinations with statins) could open additional revenue channels, benefiting from integrated therapy approaches.

Impact of Pricing and Reimbursement Policies

Reimbursement frameworks, especially in North America and Europe, influence sales volumes and profit margins. Favorable policies for generics promote volume growth but pressure prices, necessitating cost-efficient manufacturing and distribution strategies.

Potential Disruptors

• Patent litigations or regulatory bans could temporarily disrupt availability.
• Emergence of biosimilars or novel drug modalities may challenge existing formulations.
• Global supply chain considerations, including raw material scarcity or geopolitical tensions, can influence production costs and supply continuity.

Conclusion

The market for diltiazem hydrochloride remains resilient within cardiovascular therapeutics, underpinned by consistent clinical demand and expanding global access. While patent expiries and generic competition impose pricing pressures, growth opportunities persist, especially in emerging markets and through formulation innovations. Industry stakeholders should navigate regulatory landscapes carefully, leverage regional market dynamics, and explore combination therapies to sustain revenue streams.

Key Takeaways

• The global demand for diltiazem is poised for moderate growth, primarily driven by rising cardiovascular disease prevalence and formulary diversification.
• Patents expiry shifted revenues towards generics, leading to price erosion but increased market penetration.
• Emerging markets present significant growth opportunities due to increasing healthcare investments and affordability.
• Formulation innovations, including sustained-release and combination therapies, can differentiate offerings and expand indications.
• Price pressure and regulatory challenges require strategic manufacturing efficiencies and compliance to optimize financial performance.

FAQs

1. How does patent expiration affect the profitability of diltiazem hydrochloride?
   Patent expirations enable generic manufacturers to produce lower-cost alternatives, significantly reducing revenues and profit margins for original patent holders. However, they also expand market reach, especially in price-sensitive sectors, potentially offsetting losses through increased volume.

2. What are the main competitors to diltiazem in cardiovascular therapy?
   Competitors include other calcium channel blockers (like amlodipine), beta-blockers, ACE inhibitors, ARBs, and newer agents such as direct renin inhibitors. The choice depends on clinical guidelines and patient-specific factors.

3. Which regions present the most growth opportunity for diltiazem manufacturers?
   The Asia-Pacific region offers the highest growth potential due to rising disease prevalence, increasing healthcare access, and the widespread adoption of affordable generics.

4. How do formulation innovations impact market dynamics?
   Sustained-release formulations improve adherence, expand indications, and allow premium pricing. Fixed-dose combinations with other cardiovascular drugs can also create new revenue streams.

5. What role do regulatory policies play in shaping the diltiazem market?
   Regulations influence drug approval, manufacturing standardization, and reimbursement processes. Compliance ensures market access; non-compliance can lead to bans, recalls, or delayed entry, impacting revenues.

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Sources:

[1] MarketsandMarkets, "Cardiovascular Drugs Market," 2022.
[2] WHO Reports on Hypertension, 2022.
[3] GlobalData, "Emerging Markets Pharmacovigilance Outlook," 2023.
[4] Grand View Research, "Pharmaceutical Market Analysis," 2022.