PROCARDIA Drug Patent Profile

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

Procardia is a drug marketed by Pfizer and is included in two NDAs.

The generic ingredient in PROCARDIA is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Procardia

A generic version of PROCARDIA was approved as nifedipine by ACTAVIS ELIZABETH on January 8^th, 1991.

Summary for PROCARDIA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	11
Patent Applications:	4,343
Drug Prices:	Drug price information for PROCARDIA
What excipients (inactive ingredients) are in PROCARDIA?	PROCARDIA excipients list
DailyMed Link:	PROCARDIA at DailyMed

See drug prices for PROCARDIA

Recent Clinical Trials for PROCARDIA

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

Sponsor	Phase
Medical College of Wisconsin	N/A
Icahn School of Medicine at Mount Sinai	Phase 4
University of Tennessee Medical Center	Early Phase 1

See all PROCARDIA clinical trials

US Patents and Regulatory Information for PROCARDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-002	Jul 24, 1986		DISCN	Yes	No

Expired US Patents for PROCARDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-001	Approved Prior to Jan 1, 1982	3,644,627
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-002	Jul 24, 1986	3,784,684
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-002	Jul 24, 1986	3,644,627

International Patents for PROCARDIA

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	27728	METOD ZA POLUCHAVANE NA KORONARNO SREDSTVO (METHOD FOR OBTAINING OF CORONAL MEANS)
South Africa	7205808
Czechoslovakia	199202	METHOD OF PRODUCING GELATINE CAPSULES TO BE BITTEN UP

Market Dynamics and Financial Trajectory for PROCTARDIA

Last updated: August 1, 2025

Introduction

Procadia, marketed under the brand name Procardia, is the extended-release formulation of nifedipine, a calcium channel blocker primarily used to manage hypertension and angina pectoris. As a long-established pharmaceutical product, Procardia has contributed significantly to cardiovascular therapy and continues to sustain a notable market presence. Understanding its evolving market dynamics and financial trajectory requires analyzing factors such as competitive landscape, patent status, manufacturing trends, regulatory considerations, and epidemiological influences.

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Market Overview

Procardia’s therapeutic class falls within the calcium channel blockers (CCBs), a class with consistent clinical demand. The global antihypertensive drugs market, valued at approximately USD 39 billion in 2022[1], encompasses a significant share attributed to CCBs like Procardia. The drug's long history of clinical use and well-established efficacy provide a robust foundation for its ongoing market presence.

Therapeutic Use and Demographic Drivers

Procardia’s primary applications—hypertension and angina—are driven by aging populations, rising prevalence of cardiovascular diseases (CVD), and increasing awareness of hypertension management. According to the World Health Organization (WHO), CVD accounts for approximately 17.9 million deaths annually, underscoring the sustained demand for effective antihypertensive agents like Procardia[2].

Market Penetration and Regional Trends

North America remains the leading market segment, owing to high disease prevalence, advanced healthcare infrastructure, and robust reimbursement frameworks. Europe and Asia-Pacific follow, with emerging markets demonstrating accelerated growth due to economic development, increased healthcare access, and expanding patient awareness.

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Market Dynamics Impacting Procardia

Patent and Formulation Lifecycle

Procardia’s patent protection historically extended into the early 2000s, with subsequent patent expirations leading to increased generic competition. Generic nifedipine formulations now dominate many markets, exerting downward pressure on pricing and affecting branded drug revenues.

In the U.S., the last primary patent for Procardia expired around 2004[3], prompting market entry of generic versions. This patent cliff resulted in a significant revenue decline for branded formulations but broadened market access and affordability.

Generic Competition and Pricing Trends

The proliferation of generic nifedipine has transformed the competitive landscape. Generics typically capture substantial market share, leading to pricing erosion for branded versions. According to IQVIA data, generic nifedipine accounts for over 85% of prescriptions in the U.S., with average price reductions of approximately 40-60% post-patent expiry[4].

Branded formulations like Procardia rely heavily on physician prescribing habits, patient loyalty, and formulation advantages such as extended-release delivery. However, the price sensitivity due to generic competition necessitates strategic repositioning and possible focus on niche indications or formulations with bioequivalence advantages.

Regulatory and Patent Strategies

Manufacturers often pursue new indications, formulation modifications, or extended patent protections (patent term extensions, exclusivity periods) to prolong market share. Moreover, regulatory pathways such as the FDA’s 505(b)(2) permit approval of modified formulations, potentially creating barriers to generic substitution and protecting revenues.

In some cases, formulations like Procardia XL (extended-release) have benefited from such strategies. However, patent litigation and patent term gaps remain significant threats.

Manufacturing and Supply Chain Considerations

Supply chain stability and manufacturing quality influence market dynamics. Recent disruptions due to global geopolitical issues, supply chain restructuring, or regulatory compliance can impact availability, pricing, and market share.

Emergence of New Therapeutics

While Procardia continues to serve as a mainstay treatment, novel therapeutic agents—such as high-sensitivity calcium channel blockers, combination therapies, or antihypertensive regimens—may influence market share. The advent of fixed-dose combinations (FDCs) incorporating nifedipine-like molecules enhances adherence but also introduces competition from multi-drug pill formulations.

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Financial Trajectory

Revenue Trends

Procardia’s revenues have historically declined post-patent expiration due to generic competition but maintain stability through strategic marketing and formulation differentiation. Market reports suggest that globally, the drug’s sales are primarily driven by generic sales, with branded versions maintaining a niche in specific regions or indications.

In the U.S., branded Procardia’s revenues have likely decreased by over 50% since patent expiry; however, in countries with strong brand loyalty or regulatory barriers to generics, revenues persist at higher levels.

Profitability and Cost Structure

The profit margins for branded Procardia faced compression due to pricing pressures. Manufacturing costs for extended-release formulations are higher but offset by premium pricing strategies where applicable. Generic manufacturers benefit from lower R&D costs, enabling aggressive pricing and high-volume sales.

Forecasting Future Growth

The future financial trajectory depends on several factors:

• Patent and exclusivity management: Strategic patent filings and litigation outcomes could temporarily bolster revenues.
• Market expansion: Entry into emerging markets with rising CVD prevalence offers growth opportunities.
• Formulation innovation: Development of novel delivery systems or combination therapies can rejuvenate revenue streams.
• Cost management: Optimize manufacturing efficiencies, minimize supply chain disruptions, and leverage economies of scale.

Analysts project that, absent significant novel formulations or indications, revenues for Procardia branded versions are expected to stabilize or decline marginally over the next five years, paralleling trends observed across established cardiovascular drugs.

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Regulatory and Competitive Challenges

Regulatory authorities increasingly scrutinize drug safety, manufacturing quality, and patent practices. Recent crackdowns on patent evergreening and promotion of bioequivalence standards threaten extended exclusivity claims.

Meanwhile, the competitive landscape intensifies with the entry of biosimilars and novel antihypertensives, pushing the market toward price competition and therapeutic innovation.

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Conclusion

Procardia’s market dynamics are shaped by classic pharmaceutical lifecycle stages—initial patent-driven growth, subsequent patent expiry, and subsequent generic competition. Although facing revenue constraints due to generic erosion, strategic formulation differentiation, regional market expansion, and regulatory maneuvers can sustain its financial trajectory.

In the context of evolving cardiovascular therapeutics and regulatory pressures, continued innovation and market positioning are vital for maintaining its relevance.

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Key Takeaways

• Patent expirations significantly impacted Procardia’s revenue, shifting market dominance to generics.
• Regional market disparities influence revenue; North America leads, but emerging markets offer growth potential.
• Formulation differentiation and regulatory strategies remain critical to extending market share against generic competition.
• The overall market for antihypertensive drugs, including Procardia, is driven by demographic and epidemiological factors, ensuring consistent demand.
• Long-term prospects depend on innovation, formulation patents, and strategic market expansion, especially in regions with less generic penetration.

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FAQs

1. What is the primary clinical use of Procardia?
   Procardia is primarily used to treat hypertension and angina pectoris by relaxing coronary and peripheral arteries through calcium channel blockade.

2. How has patent expiration affected Procardia’s market?
   Patent expiration led to widespread generic entry, significantly reducing brand sales but increasing accessibility and lowering prices.

3. Are there recent developments or reformulations of Procardia?
   While newer formulations like Procardia XL exist, recent innovation efforts focus on formulation enhancements and combination therapies for increased efficacy.

4. What regions offer the highest growth potential for Procardia?
   Emerging markets in Asia-Pacific and Latin America offer growth prospects due to rising CVD prevalence and expanding healthcare infrastructure.

5. What strategic steps can manufacturers take to sustain Procardia’s market presence?
   Strategies include developing patent-protected formulations, expanding into new indications or markets, and leveraging regulatory pathways for extended exclusivity.

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Sources:

[1] MarketResearchFuture, "Global Antihypertensive Drugs Market," 2022.
[2] WHO, "Cardiovascular Diseases Fact Sheet," 2021.
[3] FDA Patent Archive, "Nifedipine Patent Timeline," 2004.
[4] IQVIA, "Prescription Drug Pricing Trends," 2022.