DYNACIRC CR Drug Patent Profile

When do Dynacirc Cr patents expire, and what generic alternatives are available?

Dynacirc Cr is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in DYNACIRC CR is isradipine. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the isradipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dynacirc Cr

A generic version of DYNACIRC CR was approved as isradipine by WATSON LABS TEVA on January 5^th, 2006.

Summary for DYNACIRC CR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	3
Patent Applications:	4,913
DailyMed Link:	DYNACIRC CR at DailyMed

Recent Clinical Trials for DYNACIRC CR

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

Sponsor	Phase
University of Texas at Austin	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1
Michael J. Fox Foundation for Parkinson's Research	Phase 2

See all DYNACIRC CR clinical trials

US Patents and Regulatory Information for DYNACIRC CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994		DISCN	Yes	No
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994		DISCN	Yes	No

Expired US Patents for DYNACIRC CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	4,466,972
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	5,030,456
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	4,466,972
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	4,783,337
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	4,816,263

International Patents for DYNACIRC CR

See the table below for patents covering DYNACIRC CR around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1239	DIHYDROPYRIDINE DERIVATIVES,PROCESS FOR THEIR PRODUCTION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Australia	566110
Netherlands	8401470
Finland	92554
Spain	8503503

Market Dynamics and Financial Trajectory for DYNACIRC CR

Last updated: August 17, 2025

Introduction

DYNACIRC CR (diltiazem HCl extended-release capsules) is a calcium channel blocker primarily used to manage hypertension and angina pectoris. Originally developed by Pfizer, DYNACIRC CR entered the market as part of the cardiovascular therapeutic class, targeting high-blood pressure and ischemic heart conditions. Despite its initial success, the drug's market presence has evolved significantly due to competitive shifts, patent constraints, and emerging treatment paradigms. This article explores the current market dynamics and financial trajectory for DYNACIRC CR, analyzing the factors influencing its commercial performance and prospects.

Historical Market Positioning of DYNACIRC CR

DYNACIRC CR’s formulation offers prolonged calcium channel blockade, translating to improved adherence and patient convenience over immediate-release formulations. It gained rapid adoption in the late 1990s and early 2000s, positioning itself as an efficacious and safer alternative for managing hypertension and angina.

Throughout its lifecycle, DYNACIRC CR benefitted from Pfizer’s strong marketing infrastructure and established distribution channels. Its patent exclusivity provided a lucrative window, with sales peaking in the mid-2000s. However, subsequent patent expirations and the advent of generic competitors posed significant challenges.

Market Dynamics

Competitive Landscape

The current hypertensive and angina market is saturated with multiple therapeutic options, including other calcium channel blockers, ACE inhibitors, ARBs, and novel agents like SGLT2 inhibitors. Generic versions of DYNACIRC CR and alternative pharmaceuticals have eroded its market share. Notably, the entry of generics typically results in price erosion, constraining profit margins.

Furthermore, the availability of combination therapies—such as amlodipine with other antihypertensives—reduces the reliance on monotherapy options like DYNACIRC CR. Market players increasingly favor treatments proven to improve long-term outcomes with fewer side effects.

Regulatory and Patent Considerations

DYNACIRC CR's original patent protections have long expired, with numerous biosimilars and generics entering the market. The expiry has accelerated price competition and volume decline. Additionally, regulatory pathways for reformulation or new delivery systems influence the drug’s repositioning potential.

Recent patent litigations and exclusivity extensions are critical factors impacting strategic decisions. Pfizer and generic manufacturers often engage in legal disputes to prolong market exclusivity, impacting supply and pricing.

Pharmacoeconomic and Reimbursement Factors

Reimbursement policies substantially influence DYNACIRC CR's placement within treatment protocols. In regions with strict cost-containment policies, generics dominating the market result in limited formulary placements for brand-name drugs.

Pharmacoeconomic evaluations favor drugs offering comparable efficacy at lower costs, pressuring DYNACIRC CR's revenue potential. Payers increasingly favor combination pills or newer agents with superior safety profiles, conventionally leading to a decline in DYNACIRC CR's utilization.

Emerging Treatment Trends

The paradigm shift toward personalized medicine and targeted therapies further diminishes reliance on traditional calcium channel blockers. Focus on cardiovascular risk reduction via comprehensive risk management attenuates the role of DYNACIRC CR, relegating it to niche indications or salvage therapy.

Financial Trajectory Analysis

Historical Revenue and Sales Trends

Pfizer’s revenues from DYNACIRC CR show a typical decline post-patent expiry, aligned with generic entry. Peak sales were recorded in the early 2000s, with a gradual decrease subsequently. The decline reflects market erosion, shifts in clinical practice, and generics' low pricing.

Current Market Share and Revenue Projections

Market share estimates suggest DYNACIRC CR now accounts for a minor fraction of the calcium channel blocker segment, which itself is contracting in several territories. Revenue projections indicate a continued downward trend, with estimates predicting a double-digit annual decline over the next five years unless repositioned strategically.

Forecast Scenarios

• Status Quo Scenario: Without reformulation or new indications, DYNACIRC CR’s revenue may approach negligible levels within five years.
• Repositioning Scenario: If Pfizer invests in new formulation technologies or combination products, revenue stabilization or modest growth could occur, though likely limited by clinical and regulatory hurdles.
• Licensing/Partnerships Scenario: Strategic licensing or partnerships may provide tiered revenue streams, albeit not reversing the overarching negative trend.

Potential Licensing and Market Expansion

Opportunities for growth via licensing agreements with emerging markets or unexploited indications remain limited, given competitive saturation and the availability of generics. Nevertheless, niche indications or combination therapies tailored for specific populations may offer incremental revenue.

Factors Influencing Future Financial Performance

1. Regulatory Environment: Favorable regulatory decisions may facilitate reformulation or new indications.
2. Patent Litigation Outcomes: Successful legal defenses can prolong exclusivity, impacting pricing and profitability.
3. Market Trends: Shifts towards newer, safer, and more efficacious therapies influence volume and pricing.
4. Manufacturing and Supply Chain Dynamics: Cost-efficient production can mitigate declining revenues.
5. Competitive Strategies: Effective marketing and strategic alliances could slow revenue erosion.

Conclusion

DYNACIRC CR’s market dynamics are primarily driven by patent expirations, fierce competition, and evolving clinical practices. Its financial trajectory is on a declining path absent strategic repositioning, with revenues expected to diminish substantially in the next five years. To sustain its financial viability, Pfizer or licensees must consider reformulation, new indications, or strategic partnerships. The drug’s future remains uncertain in a landscape favoring novel treatments and personalized medicine.

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Key Takeaways

• Eroding Market Share: Patent expiry and the prevalence of generics have significantly diminished DYNACIRC CR’s revenue prospects.
• Competitive Pressure: The rapid growth of combination therapies and newer agents limits its optimal positioning.
• Repositioning Opportunities: Reformulations or niche indications could provide modest growth but face regulatory and clinical hurdles.
• Market Outlook: Without strategic innovations, DYNACIRC CR's revenue is projected to decline substantially over the next five years.
• Strategic Decisions: Licensing, partnerships, or derisked repositioning strategies are essential to extend its commercial viability.

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FAQs

1. What are the main factors contributing to DYNACIRC CR’s declining market presence?
Patent expirations, increased generic competition, shifts toward combination therapies, and evolving clinical guidelines favor newer treatments, reducing demand for DYNACIRC CR.

2. Can reformulation or new indications revive DYNACIRC CR’s market appeal?
Potentially, yes. Reformulations or targeting niche indications might attract some healthcare providers, but regulatory approval and clinical validation are significant barriers.

3. How does generic competition influence DYNACIRC CR's profitability?
Generic entries significantly reduce drug prices, compress profit margins, and often lead to decreased sales volumes.

4. Are there ongoing efforts to reposition DYNACIRC CR in the market?
There are limited publicly known initiatives. Most strategic focus has shifted toward newer therapies with better safety and efficacy profiles.

5. What is the expected financial outlook for DYNACIRC CR over the next five years?
Without strategic repositioning, revenues are expected to decline sharply, potentially nearing negligible levels, influenced by further patent expirations and market shifts.

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Sources

1. Pfizer Inc. Patient Information and Historical Sales Data.
2. IMS Health Reports on Cardiovascular Drug Market Trends.
3. FDA Patent and Regulatory Archive.
4. Market Research Firm Reports on Hypertension and Angina Therapeutics.