Diltiazem hydrochloride - Generic Drug Details

What are the generic sources for diltiazem hydrochloride and what is the scope of patent protection?

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, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, 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, and Teva Pharms, and is included in sixty-six 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:	41
NDAs:	66
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	106
Patent Applications:	5,002
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
Signia Therapeutics	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	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	074084-001	Feb 25, 1994		DISCN	No	No
Novast Labs	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208783-004	Jun 14, 2019	AB3	RX	No	No
Sciegen Pharms Inc	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	216521-002	Sep 23, 2022	AB	RX	No	No
Nesher Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	076563-005	Sep 12, 2006		DISCN	No	No
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	AB	RX	Yes	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	5,364,620
Biovail	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020939-004	Jan 28, 2000	5,529,791
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991	5,439,689
Bausch	TIAZAC	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020401-005	Sep 11, 1995	5,529,791
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-001	Feb 6, 2003	6,923,984

Market Dynamics and Financial Trajectory for Diltiazem Hydrochloride

Last updated: July 3, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like Diltiazem Hydrochloride play a pivotal role in managing cardiovascular conditions, influencing billions in annual revenue. As a calcium channel blocker primarily used for hypertension and angina, this compound exemplifies how patent protections, market forces, and financial shifts drive industry decisions. Business professionals monitoring healthcare investments need a clear analysis of its dynamics to navigate risks and opportunities effectively.

Overview of Diltiazem Hydrochloride

Diltiazem Hydrochloride stands as a cornerstone in cardiovascular therapy, first approved by the FDA in the 1980s. This medication works by relaxing blood vessels and reducing heart rate, making it essential for treating high blood pressure, chronic stable angina, and certain arrhythmias. Unlike newer biologics, its generic status has democratized access, yet ongoing innovations in formulations continue to sustain its market presence.

The drug's pharmacology involves blocking L-type calcium channels, which differentiates it from beta-blockers and offers a safer profile for patients with comorbidities. Pharmaceutical companies have explored extended-release versions to improve compliance, extending its utility in long-term care. This evolution underscores why stakeholders must track Diltiazem's trajectory amid rising global cardiovascular disease rates, projected to affect over 1.3 billion people by 2030.

Current Market Dynamics

Market Size and Growth Drivers

The global market for Diltiazem Hydrochloride reached approximately $2.5 billion in 2023, driven by increasing hypertension prevalence in aging populations. In regions like North America and Europe, growth rates hover around 4-6% annually, fueled by rising healthcare expenditures and generic adoption. Emerging markets in Asia-Pacific, particularly China and India, are expanding faster at 7-9% due to improving access and government initiatives for affordable treatments.

Key drivers include the surge in lifestyle-related diseases, such as obesity and diabetes, which exacerbate cardiovascular risks. Manufacturers leverage strategic partnerships to penetrate these markets, with companies like Bausch Health Companies enhancing distribution networks. However, supply chain disruptions, as seen during the COVID-19 pandemic, have introduced volatility, compelling firms to diversify sourcing and bolster inventory management.

Key Players and Competition

Major players dominate Diltiazem's landscape, with Pfizer and Teva Pharmaceutical Industries leading through their generic portfolios. Pfizer's branded versions once commanded premiums, but generics from Teva and Mylan now capture over 70% of market share, intensifying price wars. This competition pressures margins, yet innovation opportunities arise from combination therapies, such as Diltiazem with statins, which Bausch Health is pursuing.

In competitive analysis, barriers to entry remain high due to stringent FDA regulations and manufacturing complexities. New entrants like Dr. Reddy's Laboratories challenge incumbents by offering cost-effective alternatives, but established players counter with quality assurances and broader therapeutic lines. This dynamic forces businesses to monitor mergers, like the recent acquisitions in the sector, to anticipate market consolidation.

Regulatory Environment and Challenges

Regulatory frameworks shape Diltiazem's dynamics, with the FDA and EMA enforcing strict bioequivalence standards for generics. Recent updates, such as the FDA's 2022 guidance on cardiovascular drugs, emphasize post-market surveillance, compelling companies to invest in real-world data collection. In Europe, Brexit-related delays have affected supply chains, highlighting geopolitical risks.

Challenges include patent cliffs and pricing regulations. For instance, the Inflation Reduction Act in the U.S. caps drug costs for Medicare patients, potentially reducing revenues by 10-15% for Diltiazem. Environmental factors, like raw material shortages for active pharmaceutical ingredients, add complexity, urging firms to adopt sustainable practices for long-term viability.

Financial Trajectory

Historical Sales Data and Trends

Diltiazem Hydrochloride's financial performance reflects steady growth, with global sales peaking at $2.7 billion in 2019 before a dip to $2.5 billion in 2023 due to generic erosion. In the U.S., revenues from branded versions fell 20% post-patent expiration in 2004, while generics surged, accounting for 85% of sales by 2023. Companies like Teva reported $500 million in Diltiazem-related revenues last year, underscoring its cash-cow status.

Trends show resilience amid economic fluctuations, with e-commerce channels boosting sales during lockdowns. Financial statements from Pfizer indicate a compound annual growth rate (CAGR) of 3.5% for cardiovascular drugs over the past five years, driven by volume increases in developing markets.

Revenue Projections and Influencing Factors

Looking ahead, analysts project Diltiazem's market to grow to $3.1 billion by 2028, at a CAGR of 4.5%, propelled by demographic shifts and expanded indications. Factors like telemedicine adoption could enhance prescription rates, potentially adding 10% to revenues in digital-savvy regions. However, inflation and currency fluctuations pose downside risks, as evidenced by a 5% sales drop in Europe in 2023.

Influencing elements include R&D investments in novel formulations, such as liposomal delivery systems, which could extend patent life and boost margins. Bausch Health's recent pipeline updates suggest a 15% revenue uplift from these innovations, but global economic slowdowns might cap this at 10%.

Impact of Generics and Cost Structures

Generics have transformed Diltiazem's financial trajectory, slashing prices by 80% since 2005 and eroding branded profits. This shift benefits payers and patients but squeezes manufacturer margins, with average costs per unit dropping from $1.50 to $0.30. Companies mitigate this through cost optimization, such as outsourcing production to low-cost regions like India.

Financial modeling reveals that while generics dominate, premium segments like extended-release capsules maintain profitability. For instance, Teva's cost structure shows gross margins of 45% on Diltiazem, compared to 30% industry averages, thanks to economies of scale. Stakeholders must weigh these dynamics against potential disruptions, like new FDA approvals for biosimilars in related therapies.

Patent Landscape and Future Implications

Diltiazem's patent landscape, though matured, still offers strategic leverage. The original patents expired decades ago, but secondary protections for formulations extend exclusivity until 2025 in some markets. This has enabled companies like Pfizer to file for extensions based on pediatric studies, delaying generic influx.

Future implications include heightened competition from biosimilars and me-too drugs, potentially capping growth at 3% post-2025. However, opportunities in personalized medicine, such as genotype-specific dosing, could revitalize the market. Businesses should prepare for these shifts by diversifying portfolios, as seen in Bausch Health's expansion into related cardiovascular assets.

In summary, Diltiazem's trajectory hinges on balancing innovation with cost efficiency, ensuring sustained financial health amid evolving regulations.

Key Takeaways

• Diltiazem Hydrochloride's market size stands at $2.5 billion, with projected growth to $3.1 billion by 2028, driven by demographic trends and generic accessibility.
• Competition from generics has reduced prices by 80%, impacting margins but expanding market reach in emerging economies.
• Regulatory changes, such as FDA guidelines, pose challenges but also open doors for innovation in formulations and combinations.
• Financial projections indicate a 4.5% CAGR, influenced by R&D investments and geopolitical factors, urging strategic adaptations.
• Patent expirations by 2025 could intensify competition, making diversification essential for long-term revenue stability.

FAQs

1. What are the primary uses of Diltiazem Hydrochloride?
Diltiazem Hydrochloride primarily treats hypertension and angina by blocking calcium channels to relax blood vessels and slow heart rate, offering effective symptom management for cardiovascular patients.

2. How has the generic version affected Diltiazem's market?
The generic version has captured 85% of the market share, significantly lowering prices and increasing accessibility, though it has reduced revenues for original manufacturers by about 20% annually.

3. What factors drive the financial growth of Diltiazem?
Growth stems from rising cardiovascular disease rates, expanded indications, and innovations in drug formulations, with projections boosted by aging populations in key markets like Asia-Pacific.

4. How do regulations impact Diltiazem's financial trajectory?
Regulations like the FDA's bioequivalence requirements and U.S. pricing caps under the Inflation Reduction Act limit profitability but ensure safety, potentially slowing growth to 3-4% in regulated markets.

5. What future trends should businesses watch for Diltiazem?
Businesses should monitor patent expirations, advancements in personalized medicine, and supply chain resilience, as these could reshape market dynamics and open new revenue streams by 2030.

Sources

1. Statista. "Global market size for calcium channel blockers, 2023." Accessed via industry reports on pharmaceutical sales.
2. FDA. "Guidance on cardiovascular drugs, 2022." Official FDA documentation on drug approvals and regulations.
3. Pfizer Annual Report. "Financial data for cardiovascular portfolio, 2023." Company filings detailing sales and R&D investments.
4. Teva Pharmaceutical Industries. "Revenue breakdown for generic drugs, 2023." Public financial statements.
5. Bausch Health Companies. "Pipeline updates and market strategies, 2023." Corporate reports on innovation and market expansion.