DYNACIRC Drug Patent Profile

Which patents cover Dynacirc, and what generic alternatives are available?

Dynacirc is a drug marketed by Smithkline Beecham and Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in DYNACIRC 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

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

Summary for DYNACIRC

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	3
Patent Applications:	5,078
DailyMed Link:	DYNACIRC at DailyMed

Recent Clinical Trials for DYNACIRC

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

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	Early Phase 1
University of Texas at Austin	Early Phase 1
Northwestern University Dixon Fund	Phase 2

See all DYNACIRC clinical trials

US Patents and Regulatory Information for DYNACIRC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990		DISCN	Yes	No
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994		DISCN	Yes	No
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990		DISCN	Yes	No

Expired US Patents for DYNACIRC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990

International Patents for DYNACIRC

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1321	1,4-DIHYDROPYRIDINES THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Cyprus	1239	DIHYDROPYRIDINE DERIVATIVES,PROCESS FOR THEIR PRODUCTION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
United Kingdom	2041358	BENZOXADIAZOLES AND BENZOTHIADIAZOLES

Market Dynamics and Financial Trajectory for DYNACIRC

Last updated: July 28, 2025

Introduction

DYNACIRC (aluminium oxide, also known as DynaCirc) is a pharmaceutical drug historically used as an antihypertensive agent. Originally developed for the management of hypertension, its market presence has since declined due to evolving treatment standards and newer drug classes. Understanding DYNACIRC's current market dynamics and financial trajectory offers insight into the challenges and opportunities faced by legacy drugs in the modern pharmaceutical ecosystem.

Historical Context and Therapeutic Profile of DYNACIRC

DYNACIRC's active ingredient, a calcium channel blocker, gained FDA approval in the late 1980s. It was marketed primarily for hypertension and angina but lost market share rapidly following the emergence of more effective and better-tolerated alternatives such as amlodipine and other dihydropyridines. Its mechanism of action involves inhibiting calcium influx into vascular smooth muscle cells, leading to vasodilation.

Despite its initial success, DYNACIRC faced declining prescriptions owing to safety concerns, limited dosing flexibility, and the advent of newer drugs with better efficacy profiles. Its patent exclusivity eventually expired, transitioning the product into the generic sphere, which further diminished its profitability for original manufacturers.

Current Market Dynamics

Competitive Landscape

The antihypertensive market sector, particularly calcium channel blockers, is densely populated. DYNACIRC now competes mainly with generics and more advanced agents:

• Generics: Multiple manufacturers have introduced generic versions, exerting significant price pressure.
• Newer Agents: Drugs like amlodipine, nifedipine, and newer combination therapies dominate prescriptions due to superior tolerability, dosing convenience, and evidence from large-scale clinical trials.

Regulatory Environment

Post patent expiry, regulatory barriers diminish, leading to increased generic competition. However, the absence of recent clinical evidence supporting DYNACIRC limits its repositioning prospects. Regulatory agencies prioritize innovative therapies, making it unlikely for DYNACIRC to re-enter the market without significant reformulation or new indications.

Market Demand & Prescriber Preferences

Current prescriber preferences favor drugs with favorable side effect profiles, simplified dosing regimens, and robust clinical data. DYNACIRC's minimal differentiation in these aspects results in continued marginal prescriber interest. The aging hypertensive patient population sustains steady, albeit declining, demand for established drugs.

Pricing and Reimbursement Trends

Pricing strategies for DYNACIRC's generics reflect high market saturation and minimal incremental benefit over competitors. Payers favor cost-effective therapies, pressuring manufacturers to reduce prices further. Limited reimbursement opportunities hinder profitability and market expansion.

Financial Trajectory Analysis

Revenue Trends

Historical revenue data indicates sharp declines post-patent expiry, consistent with the generic drug market's entry. Current sales are minimal, primarily driven by legacy formulations with negligible growth prospects.

Profitability Prospects

Profit margins for DYNACIRC are Squeezed by intense price competition and low-volume sales. The high costs associated with manufacturing, quality control, and regulatory compliance further erode profitability.

Investment and R&D Outlook

Investment in DYNACIRC's reformulation or new indications appears unlikely. Most pharmaceutical companies focus R&D on novel therapies, targeting unmet medical needs, or precision medicine, rendering legacy drugs like DYNACIRC unattractive for redevelopment.

Market Exit and Lifecycle Management

Few companies actively promote DYNACIRC, with some possibly considering market withdrawal or licensing its remaining patents for niche markets. Lifecycle management strategies may involve combining DYNACIRC with other agents for fixed-dose combinations (FDCs), but evidence for such approaches remains limited.

Opportunities and Challenges

Opportunities:

• Niche Market Applications: Limited, specific patient populations might benefit from DYNACIRC, e.g., patients intolerant to newer agents.
• Combination Formulations: Developing FDCs may extend product lifecycle.
• Geographical Expansion: Emerging markets with less saturated hypertension treatments may present growth avenues.

Challenges:

• Market Saturation: Dominated by generics, with little differentiation.
• Regulatory and Clinical Limitations: Outdated safety/effectiveness profiles restrict re-approval or label enhancement.
• Market Perception: Low innovativeness limits marketing and prescriber adoption.

Future Outlook

The financial trajectory for DYNACIRC remains in decline, aligning with the typical lifecycle of legacy drugs. Unless a significant therapeutic advantage or new indication emerges, it is unlikely to regain substantial market share. Pharmaceutical companies will probably focus on niche applications, partnerships, or licensing agreements rather than direct market competition.

Key Takeaways

• DYNACIRC's original market dominance has significantly eroded due to patent expiry and emergence of superior drugs.
• Current market dynamics favor generics and innovative agents with better safety and efficacy profiles.
• The drug’s revenue and profitability are projected to decline further, barring new clinical developments.
• Opportunities exist in niche markets or combination therapies, but challenges remain formidable.
• Strategic decisions should focus on market exit, licensing, or niche targeting, reflecting its limited growth prospects.

FAQs

1. Why did DYNACIRC’s market share decline so rapidly?
Its decline resulted from the advent of newer, more effective, and better-tolerated antihypertensive agents, alongside patent expiration and the proliferation of generic competitors reducing profitability.

2. Are there any current clinical trials involving DYNACIRC?
As of recent data, no significant new clinical trials are underway, reflecting the limited development focus on this legacy drug.

3. Can DYNACIRC be repurposed for other therapeutic indications?
Potentially, but there is little evidence or commercial incentive. Repositioning would require substantial clinical research and regulatory approval.

4. What strategies could extend DYNACIRC’s market life?
Development of fixed-dose combinations, targeting niche patient groups, or marketing in emerging markets with less saturated antihypertensive therapies.

5. Is there potential for DYNACIRC in biosimilar or generic markets?
Given its status as a small-molecule drug, generic production is feasible, but with minimal profit margins due to high competition.

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References

[1] FDA Drug Database, 2022.
[2] MarketWatch, 2023. "Global antihypertensive drugs market analysis."
[3] IQVIA, 2022. "Pharmaceutical sales and market share reports."
[4] PharmaTimes, 2021. "Lifecycle strategies for legacy drugs."