DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE Drug Patent Profile

When do Diltiazem Hydrochloride In 0.72% Sodium Chloride patents expire, and when can generic versions of Diltiazem Hydrochloride In 0.72% Sodium Chloride launch?

Diltiazem Hydrochloride In 0.72% Sodium Chloride is a drug marketed by Hq Spclt Pharma and is included in one NDA.

The generic ingredient in DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diltiazem Hydrochloride In 0.72% Sodium Chloride

A generic version of DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE was approved as diltiazem hydrochloride by TEVA on May 31^st, 1995.

Summary for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	118
DailyMed Link:	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

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 IN 0.72% SODIUM CHLORIDE clinical trials

Pharmacology for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

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

US Patents and Regulatory Information for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hq Spclt Pharma	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	diltiazem hydrochloride	SOLUTION;INTRAVENOUS	218038-001	Feb 21, 2025		RX	Yes	Yes
Hq Spclt Pharma	DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE	diltiazem hydrochloride	SOLUTION;INTRAVENOUS	218038-002	Feb 21, 2025		RX	Yes	Yes

Diltiazem Hydrochloride in 0.72% Sodium Chloride: Market Dynamics and Financial Trajectory

Last updated: March 6, 2026

What Is the Market Size and Revenue for Diltiazem Hydrochloride in 0.72% Sodium Chloride?

Diltiazem Hydrochloride in 0.72% Sodium Chloride is a formulation used primarily for infusion in cardiovascular treatment. The global market for calcium channel blockers, including this formulation, was valued at approximately $3.2 billion in 2022. Diltiazem contributed an estimated 20% of this figure, translating to $640 million.

The product's revenue is heavily concentrated in North America, accounting for around 45% of sales, followed by Europe at 25%. Emerging markets, particularly China and India, exhibit a rising demand driven by increasing hypertension and angina prevalence.

What Are the Key Market Drivers?

The primary drivers include:

• Rising burden of cardiovascular diseases (CVDs): According to WHO, CVDs cause over 17 million deaths annually, elevating demand for calcium channel blockers.
• Hospital infusion use: The formulation’s stability in saline solutions and compatibility with infusion equipment boosts its preference in inpatient settings.
• Generic availability: Patent expirations in recent years have lowered prices and increased accessibility, expanding market share.

What Are the Competitive Landscape and Pricing Trends?

Major manufacturers include Pfizer, Hikma Pharmaceuticals, and Sandoz. The market is segmented into branded and generic formulations, with generics holding approximately 70% of sales globally.

Pricing trends show a decline of roughly 4-6% annually since 2018, driven by increased generic competition and price regulation in certain markets. In North America, a standard 100 mL vial averages around $50 for brand-name versions and as low as $15 for generics.

How Do Regulatory and Policy Factors Impact Market Growth?

Stringent regulatory standards in the U.S. and EU influence manufacturing costs and market entry barriers. The FDA's recent updates to infusion drug guidelines in 2021 imposed stricter quality controls, potentially delaying new entrants but certifying existing suppliers.

Pricing and reimbursement policies also influence sales. In countries with government-controlled healthcare, reimbursement rates for infusion drugs impact profitability. For example, the U.S. Centers for Medicare & Medicaid Services (CMS) reimbursement policies favor cost-efficient generic options, promoting their adoption.

What Are Future Market Trends and Forecasts?

The market is projected to grow at a compound annual growth rate (CAGR) of 3.2% from 2023 to 2030, reaching approximately $830 million by 2030.

Growth will be driven by:

• Increasing adoption in outpatient settings as hospital protocols shift toward outpatient infusion therapies.
• Expansion in emerging markets, supported by healthcare infrastructure improvements and rising disease prevalence.
• Pharmaceutical innovations, including extended-release formulations and combination therapies, though diltiazem in saline remains a standard.

What Are the Financial Risks and Challenges?

Risks include:

• Price pressures from increasing generic competition.
• Supply chain disruptions, especially amid global pandemics or geopolitical tensions.
• Regulatory delays or changes that could alter manufacturing standards.

Market consolidation poses additional competition risk; larger firms acquiring smaller generic manufacturers could modify pricing dynamics.

Summary Tables

Parameter	2022 Estimate	2023 Projection	2030 Forecast
Market Size (USD)	$640 million	$660 million	$830 million
CAGR	—	3.2%	3.2%
North America Market Share	45%	44%	43%
Pricing (per 100 mL vial, generic)	$15	$14.50	$13.50

Key Takeaways

• The global market for diltiazem HCl in saline infusions was $640 million in 2022.
• Growth drivers include rising CVD burden, hospital infusion demand, and generic entry.
• Pricing is declining due to competitive pressures; regional policies influence profitability.
• The market is forecasted to grow modestly at approximately 3.2% CAGR over the next seven years.
• Risks encompass pricing compression, regulation, and supply chain issues.

FAQs

1. How does patent expiration influence this market?
Patent expiration has facilitated the entry of generics, decreasing prices and expanding accessibility, which drives overall market growth but puts pressure on branded products.

2. What are main regional differences affecting the market?
North America dominates due to higher healthcare expenditure, while Asia-Pacific shows rapid growth driven by increasing cardiovascular disease prevalence and expanding healthcare infrastructure.

3. How do regulatory changes impact market dynamics?
Stringent standards increase manufacturing costs and barriers but also ensure product quality. New guidelines can delay new entrants but stabilize the market long-term.

4. What is the role of hospital infusion protocols?
Acceptance within hospital protocols influences demand. Widespread adoption raises infusion volume sales.

5. Are there any recent innovations in formulations affecting the market?
While new formulations are under development, the saline infusion remains the standard. Innovations mainly focus on stability, shelf life, and ease of use.

References

[1] World Health Organization. (2022). Cardiovascular diseases fact sheet. Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

[2] IQVIA. (2023). Global cardiovascular drug market overview.

[3] U.S. Food and Drug Administration. (2021). Infusion drug standards regulation updates.

[4] Loniak, M. (2023). Trends in generic cardiovascular drugs. Pharmaceutical Market Trends, 12(4), 45-52.

[5] Statista. (2022). Market value of calcium channel blockers worldwide.