PROCARDIA XL Drug Patent Profile

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

Procardia Xl is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in PROCARDIA XL 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 Xl

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

Summary for PROCARDIA XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	11
Patent Applications:	4,330
Drug Prices:	Drug price information for PROCARDIA XL
DailyMed Link:	PROCARDIA XL at DailyMed

See drug prices for PROCARDIA XL

See drug sales revenues for PROCARDIA XL

Recent Clinical Trials for PROCARDIA XL

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
High Risk Obstetrical Consultants	Early Phase 1

See all PROCARDIA XL clinical trials

Pharmacology for PROCARDIA XL

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

US Patents and Regulatory Information for PROCARDIA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	AB2	RX	Yes	Yes

Expired US Patents for PROCARDIA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989

International Patents for PROCARDIA XL

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

Country	Patent Number	Title	Estimated Expiration
Finland	72648
Austria	A88084
Australia	566110
Denmark	99784
Austria	397180

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROCARDIA XL

Last updated: July 29, 2025

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Introduction

Procadia XL, a once-prominent cardiovascular pharmaceutical, has experienced notable shifts in market dynamics and financial performance over recent years. As a sustained-release formulation of nifedipine, Procadia XL has traditionally been prescribed for hypertension and angina pectoris. This report delineates its current market landscape, financial trajectory, competitive environment, regulatory influences, and future outlook, enabling stakeholders to navigate the evolving pharmaceutical terrain effectively.

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Market Overview and Clinical Positioning

Procadia XL belongs to the calcium channel blocker class, primarily targeting hypertensive and ischemic cardiovascular conditions. Its extended-release formulation offers advantages in compliance and steady plasma drug levels, making it suitable for chronic management. The global cardiovascular therapeutics market, valued at approximately $120 billion in 2022, underpins the demand for drugs like Procadia XL, driven by the rising prevalence of hypertension and coronary artery disease—conditions projected to escalate due to aging populations and lifestyle factors ^[1].

However, the market has gradually shifted towards novel agents and fixed-dose combinations, which challenge traditional monotherapy medications such as Procadia XL. The ascendancy of generic versions further influences its market share, with patent expirations often acting as catalysts for price erosion.

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Market Dynamics

1. Patent Expiry and Generic Competition

Procadia XL's patent protection, which originally granted exclusivity until around 2015, allowed for premium pricing. Subsequent patent cliffs led to the proliferation of generics—producing substantial price competition. Generic nifedipine extended-release products, available from multiple manufacturers, have commoditized the drug, reducing revenue streams for branded versions.

2. Regulatory Factors

Regulatory agencies, such as the FDA and EMA, have implemented policies to streamline approval processes for generics and biosimilars, intensifying market competition. Additionally, the regulatory landscape has tightened around labeling claims and quality standards, influencing manufacturing costs and market viability ^[2].

3. Prescriber and Patient Preferences

Clinicians increasingly favor combination therapies or newer agents with favorable side effect profiles. Patients demand drugs with fewer dosing restrictions, which has driven the adoption of fixed-dose combinations over monotherapies like Procadia XL. Moreover, shifts towards personalized medicine and pharmacogenomics may diminish the role of traditional drugs like nifedipine.

4. Emerging Market Penetration

Emerging markets such as India, China, and Latin America continue to exhibit high growth potential due to insufficient healthcare infrastructure and rising disease burden. Price-sensitive consumers favor generics, which constrains branded drug revenues but offers opportunities for margin stabilization through cost-effective manufacturing.

5. Competitive Landscape

Key competitors include other extended-release nifedipine formulations by pharmaceutical giants such as Bayer (Adalat XL) and Teva. Additionally, newer antihypertensive agents—such as angiotensin receptor blockers (ARBs) and direct vasodilators—offer alternative treatment options, eroding Procadia XL's market share.

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Financial Trajectory Analysis

Historical Performance

Following patent expiration and market saturation in the early 2010s, traditional branded sales of Procadia XL declined markedly. Companies reliant on the original formulation saw a revenue erosion estimated at 35-50% over five years post-patent expiry, driven chiefly by generic substitution and aggressive pricing ^[3].

Current Financial Status

Currently, Procadia XL's revenue streams are primarily driven by generic sales and formulations licensed to emerging markets. Gross margins have narrowed, with industry averages for generics hovering around 20-30%. R&D investment in this segment has diminished, focusing instead on newer formulations or combination therapies.

Forecasted Trends

Analysts project a continued decline in branded Procadia XL revenues through 2025, barring new patent protections or formulation enhancements. Meanwhile, generic manufacturers project stable but declining revenues with market saturation. However, potential niche applications or formulation innovations could temporarily stabilize or augment revenues.

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Regulatory and Policy Impact

Recent regulatory trends favor the approval of bioequivalent generics, further intensifying competition and likely pressuring prices downward. Additionally, evolving healthcare policies favor cost-effective therapies, incentivizing switch to generics and biosimilars. Conversely, regulatory hurdles for new formulations or delivery systems could slow innovation, limiting high-margin opportunities.

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Future Outlook and Strategic Implications

The outlook for Procadia XL is largely characterized by market saturation and commoditization, constraining revenue growth. Pharmaceutical companies may leverage portfolio diversification, generic manufacturing efficiencies, or development of new formulations to sustain profitability. Strategic licensing and partnerships in emerging markets could unlock untapped revenue streams.

Innovative approaches, such as combining nifedipine with other antihypertensives into fixed-dose combinations or developing sustained-release formulations with improved bioavailability, could rekindle interest. However, significant R&D investment and regulatory approval processes are prerequisites, potentially diminishing short-term financial gains.

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Key Market Drivers

• Growing global burden of hypertension and cardiovascular disease.
• Patent expirations driving generic proliferation.
• Healthcare policies emphasizing cost containment.
• Emerging markets offering scalable growth opportunities.
• Technological advances enabling new formulations.

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Risks and Challenges

• Market erosion due to price competition.
• Preference shifts towards newer therapies and combination treatments.
• Regulatory barriers to novel formulations.
• Pricing pressures in price-sensitive markets.
• Potential demand decline due to evolving clinical guidelines.

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Conclusion

Procadia XL's market trajectory underscores the critical influence of patent lifecycle, competitive innovation, and evolving clinical practices on its financial sustainability. While traditional formulations struggle against generic parity and alternative therapies, niche applications, formulation innovation, and strategic expansion in emerging markets offer pathways to preserve value. Stakeholders must remain vigilant to regulatory trends and market preferences to optimize positioning.

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Key Takeaways

• Patent expirations and generic entries have significantly compressed Procadia XL's revenue potential, necessitating a shift toward diversification.
• Market dynamics favor the development of combination therapies and innovative formulations to regain competitive edge.
• Emerging markets represent growth opportunities due to favorable pricing and healthcare infrastructure expansion.
• Regulatory frameworks continue to influence availability, pricing, and development timelines for new or reformulated products.
• Strategic R&D investments into novel delivery systems could extend the product’s lifecycle and profitability.

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FAQs

1. What factors contributed to the decline in Procadia XL’s market share?
Patent expiration, increased generic competition, shifts in prescriber preferences toward newer therapies, and the emergence of combination drugs reduced its dominance.

2. How do regulatory policies affect the future of Procadia XL?
Stricter bioequivalence requirements and streamlined approval processes for generics expand competition, further pressuring prices and revenues for branded versions.

3. Are there ongoing innovations to rejuvenate the Procadia XL franchise?
Yes, through formulation innovations such as fixed-dose combinations, improved sustained-release systems, and exploring new indications—though these require significant R&D and regulatory approval.

4. What are the strategic opportunities in emerging markets for Procadia XL?
Manufacturers can leverage lower production costs, less saturated markets, and high cardiovascular disease prevalence to expand sales, particularly through licensing and local partnerships.

5. What is the outlook for branded Procadia XL over the next five years?
Revenue is expected to decline further unless countered by innovation, market expansion, or regulatory protections. Focus may shift increasingly toward generic portfolios and niche applications.

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References

1. Global Cardiovascular Therapeutics Market Size & Share 2022. MarketResearch.com.
2. Regulatory Trends in Generic Drug Approvals. U.S. Food and Drug Administration.
3. Patent Cliff Impact on Cardiovascular Drugs. PharmaIntelligence, 2018.