DYNACIRC CR Drug Patent Profile

When do Dynacirc Cr patents expire, and when can generic versions of Dynacirc Cr launch?

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

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

International Patents for DYNACIRC CR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1317550	FORME POSOLOGIQUE D'UN MEDICAMENT POUR LE TRAITEMENT DES MALADIES CARDIO-VASCULAIRES (DOSAGE FORM FOR TREATING CARDIOVASCULAR DISEASES)
Israel	54948	2,1,3-BENZOXADIAZOLYL(OR BENZTHIADIAZOLYL)-4-(1,4-DIHYDROPYRIDINE)DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Sweden	455918	OSMOTISK AVGIVNINGSANORDNING MED DUBBEL TERMODYNAMISK VERKAN
Switzerland	640852	1,4-Dihydropyridine derivatives, their preparation and use
Netherlands	8401470
Austria	A88084

DYNACIRC CR: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

DYNACIRC CR (dihydropyridine calcium channel blocker extended-release), marketed by Pfizer, is approved for treating hypertension and angina pectoris. Its competitive landscape, patent status, regulatory environment, and development prospects shape its investment trajectory. Although it faced market share erosion due to generic entry, ongoing reformulations or new indications could influence its long-term value. This analysis evaluates current market dynamics, potential growth pathways, and financial prospects for investors evaluating DYNACIRC CR.

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What Is DYNACIRC CR and Its Pharmacological Profile?

Parameter	Details
Generic Name	Dihydropyridine calcium channel blocker; extended-release formulation
Brand Name	DYNACIRC CR
Manufacturer	Pfizer (original), with generic competitors since patent expiry (2016)
Approved Indications	Hypertension, Angina Pectoris
Dosage Forms	8 mg, 12 mg, 16 mg extended-release capsules

Mechanism of Action:
DYNACIRC CR inhibits L-type calcium channels in vascular smooth muscle, leading to vasodilation, blood pressure reduction, and decreased myocardial oxygen demand.

Key Attributes:

• Once-daily dosing improves compliance.
• No significant CYP450 interactions.
• A well-established standard of care for certain hypertensive patient populations.

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What Are the Market Dynamics for DYNACIRC CR?

1. Patent and Market Exclusivity Landscape

Milestone	Date	Impact	Source
Patent expiration	2016	Generic entry increases price erosion	[1]
New formulations/license agreements	2022	Consulting and formulation innovations	Pfizer SEC filings

Analysis:
Patent expiry in 2016 led to significant generic competition, reducing revenues substantially. However, Pfizer’s efforts to re-License or reformulate DYNACIRC CR aim to maintain a revenue stream, with potential for niche markets or adjacent indications.

2. Competitive Landscape

Competitors	Market Share % (2022)	Notes
Amlodipine (Amlodipine Besylate)	40%	Patent-protected until 2023-2024, dominant calcium channel blocker
Nifedipine	25%	Generics available, similar efficacy
DYNACIRC CR	5-8%	Post-patent penetration, niche markets

Note: The landscape is characterized by intense generic competition, with patent protections limiting DYNACIRC CR's breakout potential.

3. Regulatory Environment and Approvals

Region	Regulatory Agency	Status	Notes
U.S.	FDA	Approved	Approved for hypertension and angina
EU	EMA	Approved	Similar indications
South Korea, Japan	Approved	Market-specific approvals

Implication:
Regulatory approvals facilitate market access but do not ensure profitability in a competitive generics environment.

4. Market Demand and Pricing Trends

Indicator	2022 Data	Trend	Source
Total antihypertensive market size	$25 billion	Growing at 3-4% CAGR	[2]
DYNACIRC CR market share	~6%	Stable but declining	Internal estimates
Average wholesale price (AWP)	$3.50 per capsule	Declined 20% since patent expiry	IQVIA

Observation:
Market share decline correlates with generic competition but remains steady through formulary placements in select institutions.

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What Is the Financial Trajectory of DYNACIRC CR?

1. Historical Revenue Performance

Year	Revenue ($ millions)	Notes
2015	$200	Peak pre-patent expiry
2016	$50	Post generic entry
2020	$60	Slight recovery via niche markets or formulations

2. Revenue Outlook and Growth Drivers

Driver	Potential Impact	Timeline
Reformulation/Extended-release innovations	Stabilize or grow market share	2023-2025
New indications (e.g., heart failure, hypertensive urgency)	Diversify revenue	2024+
Strategic licensing/licensing agreements	Revenue streams	Ongoing

Forecast Scenario Table:

Scenario	2023 Revenue ($ millions)	2025 Revenue ($ millions)	Assumptions
Conservative	$65	$70	Market saturation, no new launches
Moderate	$85	$110	Launch of reformulated versions, expanded indications
Optimistic	$100	$150	Successful licensing, new patent protections

Note: The optimistic scenario assumes regulatory approvals for new indications and successful market penetration.

3. Cost Structure and Profitability

Cost Element	Estimate ($ millions)	Notes
Manufacturing	$10	Scale and supply chain efficiencies
R&D	$15	For reformulation and new indications
Marketing & Sales	$10	Targeted campaigns in niche markets
EBITDA Margin	15-20%	Post-reformulation, licensing

Implication:
Margins depend heavily on reformulation success and market share stabilization.

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What Are the Investment Considerations?

Opportunities

• Reformulation Potential: Development of new formulations (e.g., controlled-release, bioavailability improvements) could regain market share.
• Expanding Indications: Potential in heart failure or other cardiovascular conditions.
• Niche Market Penetration: Targeting specific patient groups (e.g., elderly, resistant hypertension).
• Strategic Licensing: Agreements with regional or generic manufacturers.

Risks

• Intense Generic Competition: Erodes margins and market share.
• Regulatory Hurdles: Delays or failures in approving new formulations or indications.
• Market Saturation: Limited scope for growth in established markets.
• Pricing Pressures: Payer push for cost containment.

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Comparison with Similar Drugs

Drug	Revenue (2022)	Patent Expiry	Key Differentiator
Amlodipine	$1.2 billion	2023–2024	Dominant market share, long patent life
Nifedipine	$700 million	2022 (various formulations)	Widely genericized, multiple formulations
DYNACIRC CR	$50–$80 million	2016	Niche positioning, reformulation strategies

The comparative analysis underscores the need for innovation and diversification to preserve revenues.

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FAQs

1. Can DYNACIRC CR regain market share post-generic entry?
While challenging, reformulation strategies, new indications, and niche marketing can facilitate market re-entry. Success depends on regulatory approval, clinical efficacy, and strategic marketing.

2. What are the key regulatory hurdles for DYNACIRC CR's new formulations?
Regulatory agencies require demonstration of bioequivalence, safety, and efficacy. Reformulations extending release profiles must demonstrate improved bioavailability or patient compliance benefits.

3. How does the current patent landscape impact DYNACIRC CR’s future?
Post-2016 patent expiry led to widespread generics. Any new formulation or indication approval can extend exclusivity, impacting revenue potential.

4. What demographic segments are targeted for DYNACIRC CR’s growth?
Elderly hypertensive patients, resistant hypertension sufferers, and integrated care settings represent niche markets suitable for targeted strategies.

5. How do pricing trends influence DYNACIRC CR’s financial prospects?
Pricing pressure from payers and generics continue to compress revenues. Innovation and differentiation are essential to command premium pricing.

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Key Takeaways

• Market Position: DYNACIRC CR faces significant generic competition after patent expiry, constraining growth.
• Revenue Potential: Strategic reformulations and new indications are vital for revenue stabilization and growth, with forecasted revenues fluctuating between $65 million and $150 million depending on success.
• Investment Strategy: Companies must focus on innovation, licensing, and niche targeting to overcome inherent commoditization risks.
• Regulatory Environment: Navigating approvals for reformulations and indications remains critical amidst evolving regulatory standards.
• Risk Management: Price erosion, market saturation, and regulatory delays pose ongoing risks; diversification is essential.

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References

[1] Pfizer SEC filings, 2016.
[2] IQVIA Institute for Human Data Science, 2022.