DILACOR XR Drug Patent Profile

When do Dilacor Xr patents expire, and when can generic versions of Dilacor Xr launch?

Dilacor Xr is a drug marketed by Allergan and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilacor Xr

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

Summary for DILACOR XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	1
Patent Applications:	3,360
DailyMed Link:	DILACOR XR at DailyMed

Recent Clinical Trials for DILACOR XR

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

Sponsor	Phase
Assiut University	Early Phase 1

See all DILACOR XR clinical trials

US Patents and Regulatory Information for DILACOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992		DISCN	Yes	No
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-002	May 29, 1992		DISCN	Yes	No
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992		DISCN	Yes	No

Expired US Patents for DILACOR XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-001	May 29, 1992
Allergan	DILACOR XR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020092-003	May 29, 1992

International Patents for DILACOR XR

See the table below for patents covering DILACOR XR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69026215
Denmark	0432607
Italy	1188212	SISTEMA PER IL RILASCIO A VELOCITA' CONTROLLATA DI SOSTANZE ATTIVE

Market Dynamics and Financial Trajectory for DILACOR XR

Last updated: July 29, 2025

Introduction

DILACOR XR (Diltiazem Extended-Release) is a cardiovascular drug indicated primarily for the management of hypertension and angina pectoris. Its extended-release formulation offers sustained therapeutic plasma concentrations, improving patient compliance and outcomes. As a generic or branded medication depending on the market, understanding its market dynamics and financial trajectory involves analyzing the competitive landscape, regulatory environment, patient demand, and emerging healthcare trends.

Market Overview

The global cardiovascular drug market, projected to reach approximately $60 billion by 2025, exhibits sustained growth driven by aging populations, lifestyle-related risk factors, and expanding healthcare infrastructure. Diltiazem, a calcium channel blocker, maintains a significant share within this segment owing to its efficacy and safety profile.

DILACOR XR, as a sustained-release diltiazem formulation, taps into an established market with high demand from hypertensive and angina patients. Its formulation enhances adherence through reduced dosing frequency, positioning it favorably for both branded and generic supply chains.

Market Dynamics

Competitive Landscape

DILACOR XR operates within a highly competitive environment characterized by multiple formulations of diltiazem, including immediate-release, sustained-release, and combination therapies. Notable competitors include:

• Cardizem CD (Cardizem CD) (by Biotronik)
• Dilzem SR and Diltia SR (generic formulations)
• Tiazac (by Depomed, now part of Purdue Pharma)

The entry of generics significantly impacts pricing pressures and market share, especially in mature markets like the US, Europe, and Asia. Patent expiration periods influence the timeline for generic competition, which in turn affects the financial prospects of DILACOR XR.

Regulatory Environment

DILACOR XR benefits from regulatory approvals that affirm its safety and efficacy, though patent protections and exclusivity rights heavily influence its market exclusivity. The expiration of patents typically prompts a surge in generic entry, leading to price erosion. Conversely, approval of biosimilars or innovative delivery systems could reshape competitive dynamics.

Patient Demand and Prescribing Trends

The increasing prevalence of hypertension and ischemic heart disease drives steady demand for calcium channel blockers like diltiazem. Patients increasingly prefer once-daily formulations like DILACOR XR due to convenience and improved compliance. Physicians favor such formulations for their consistent pharmacokinetic profiles, which reduce adverse effects linked to fluctuating plasma drug levels.

Geographical Considerations

The North American market remains the largest for cardiovascular drugs, followed by Asia-Pacific and Europe. Emerging markets show rapid growth potential, driven by urbanization and evolving healthcare infrastructure, although pricing and regulatory hurdles are notable challenges.

Financial Trajectory

Revenue Streams

DILACOR XR's revenue heavily relies on:

• Market penetration in developed regions
• Pricing strategies aligning with insurance reimbursement policies
• Generic competition influencing profit margins
• Approvals in emerging markets expanding sales footprint

Impact of Patent Expiry and Generics

Patent expiration—anticipated within the next 2-3 years in key markets—could lead to a sharp decline in brand-name sales unless strategic pivots are undertaken. Generics typically price 30-80% lower than branded formulations, compelling manufacturers to innovate or differentiate their offerings.

Strategic Initiatives

To sustain financial growth, manufacturers are adopting:

• Line extension strategies (fixed-dose combinations)
• Market expansion initiatives in emerging regions
• Partnerships with local distributors
• Investments in pharmacovigilance to ensure compliance and avoid costly recalls

Projected Growth

Analyst forecasts indicate modest growth for DILACOR XR in mature markets, with compound annual growth rates (CAGRs) around 2-4% over the next five years, contingent on successful market strategies and regulatory hurdles. Emerging markets could exhibit higher CAGRs, approaching 8-12%, driven by increasing cardiovascular disease burden.

Factors Influencing Future Financial Performance

• Patent Strategy: Delays in patent expiration or strategic patent filings can prolong exclusivity, sustaining higher margins.
• Pricing and Reimbursement: Negotiations with payers, especially in cost-sensitive markets, influence net revenues.
• Pipeline Development: New formulations, combination therapies, and delivery systems improve competitive positioning.
• Regulatory Approvals: Rapid approvals in emerging markets expand access and revenue avenues.
• Market Penetration Efforts: Effective marketing, physician education, and patient awareness campaigns enhance adoption rates.

Key Market Challenges

• Price competition from generics
• Regulatory uncertainties in certain jurisdictions
• Healthcare policy shifts, favoring cost-effective therapies
• Emergence of novel drug delivery systems, threatening traditional formulations

Conclusion

DILACOR XR's financial trajectory is shaped by a complex interplay of patent life cycle, competitive dynamics, and evolving healthcare policies. While near-term prospects face challenges from generic erosion, strategic innovations and expanding markets offer avenues for sustained growth. Investors and industry stakeholders should monitor patent timelines, regulatory environments, and emerging market opportunities to optimize decision-making.

---

Key Takeaways

• DILACOR XR remains a significant player within the calcium channel blocker space, with dependable demand driven by hypertension and angina prevalence.
• Patent expiration and generic entry are critical factors influencing future revenue, necessitating strategic planning for patent prolongation or innovation.
• Competitive pressures are intensifying; differentiation via fixed-dose combinations and novel formulations can enhance market position.
• Emerging markets present substantial growth opportunities, counterbalancing mature market declines.
• Price negotiations and reimbursement policies will significantly impact profitability, underscoring the importance of health economics and outcomes research.

---

FAQs

1. When is DILACOR XR expected to face generic competition?
Patent expiration dates typically occur within 2-3 years in major markets like the US and Europe. Specific patent data should be reviewed for precise timelines, but generic competition is imminent unless patent extensions or exclusivity strategies are employed.

2. How can manufacturers sustain profitability post-patent expiration?
By diversifying through line extensions, developing combination therapies, entering emerging markets, and investing in innovative drug delivery systems to offer differentiated products.

3. What emerging markets show the greatest potential for DILACOR XR?
Asia-Pacific, Latin America, and parts of Africa demonstrate rapid cardiovascular disease development and expanding healthcare infrastructure, making them promising markets for future growth.

4. How does reimbursement policy influence DILACOR XR’s market potential?
Reimbursement policies impact patient access and prescribing habits. Favorable policies and insurance coverage bolster sales, whereas restrictive reimbursement can hinder market penetration.

5. What regulatory challenges could impact DILACOR XR’s global sales?
Differing approval standards, delays in registration processes, and evolving safety requirements in various jurisdictions can pose obstacles to timely market entry and expansion.

---

Sources:
[1] Global Cardiovascular Drugs Market Report, MarketsandMarkets, 2022.
[2] Patent expiry data for diltiazem formulations, FDA.gov.
[3] Industry analysis on generic drug entry strategies, IQVIA Insights.
[4] World Health Organization, Global Status Report on Noncommunicable Diseases, 2021.
[5] Regulatory guidelines for cardiovascular drugs, EMA.