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:	165
Clinical Trials:	11
Patent Applications:	3,778
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
University of Tennessee Medical Center	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	5,264,446
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	4,783,337
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	5,264,446
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	4,783,337
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	4,327,725
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	5,264,446

International Patents for PROCARDIA XL

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

Country	Patent Number	Title	Estimated Expiration
Portugal	73603	PROCESS FOR THE PREPARATION OF SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING NIFEDIPIN HAVING AN ACTION ON THE BLOOD CIRCULATION
Australia	566110
Australia	558331
Ireland	51549	SOLID MEDICAMENT FORMULATIONS CONTAINING NIFEDIPINE,AND PROCESSES FOR THEIR PREPARATION
Australia	2251183
Germany	3033919

PROCARDIA XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROCARDIA XL (Nifedipine)

Market Overview

The market for nifedipine, particularly for formulations like PROCARDIA XL, is driven by several key factors that influence its growth and financial trajectory.

Prevalence of Cardiovascular Diseases

The increasing global prevalence of hypertension and other cardiovascular diseases is a significant driver for the nifedipine market. As the population grows and ages, the incidence of these conditions is expected to rise, leading to higher demand for effective and affordable medications like nifedipine[1][3][4].

Patient Adherence and Compliance

Patient adherence to prescribed medications is crucial for the success of nifedipine in the market. Extended-release and controlled-absorption formulations like PROCARDIA XL improve compliance by reducing the number of daily doses, which can lead to better treatment outcomes and increased market demand[3][5].

Generic Competition and Pricing

The availability of generic versions of nifedipine has impacted the pricing and competition within the market. Generic forms often result in lower prices, making the drug more accessible to a larger population. However, this also means that branded products like PROCARDIA XL must compete on factors such as efficacy, convenience, and patient preference[1][3].

Technological Advancements

Advances in pharmaceutical technologies, such as improved drug delivery systems, can enhance the market position of nifedipine. New formulations that offer better efficacy, reduced side effects, or more convenient dosage options can gain market share and revive revenue streams for companies producing nifedipine[1][3].

Regulatory Environment

Changes in regulatory policies and approvals can significantly affect the market dynamics of nifedipine. Updates in safety standards or new indications approved by regulatory bodies can impact market growth and competitiveness[3].

Emerging Markets and Healthcare Infrastructure

The expansion of healthcare infrastructure in emerging markets and increased awareness about cardiovascular health contribute to the growth of the nifedipine market. Initiatives such as India's National Health Policy, which aims to reduce early cardiovascular deaths, and programs like the Rashtriya Arogya Nidhi (RAN) initiative, enhance access to healthcare services and medications, driving market demand[4].

Financial Trajectory

Market Size and Growth

The global nifedipine market, including formulations like PROCARDIA XL, is projected to experience significant growth. The market size was valued at approximately $1,049.6 million in 2022 and is expected to reach $1,967.2 million by 2030, growing at a CAGR of 9.4% during this period[1].

Regional Market Performance

North America, particularly the U.S., represents the largest market for nifedipine due to high rates of hypertension. This region is expected to grow at a CAGR of 8.5% over the forecast period. The Asia-Pacific region is also anticipated to exhibit strong growth, with a CAGR of 8.8%, driven by increasing healthcare access and infrastructure development[4].

Cost Savings and Economic Impact

Switching patients from more expensive formulations like Procardia XL to less expensive alternatives like Adalat CC can result in significant cost savings. For example, a study using Medicaid claims data in Pennsylvania showed potential savings of more than $2.5 million annually by switching patients from Procardia XL to Adalat CC, without adverse effects on blood pressure control or nonprescription healthcare costs[2].

Revenue Streams and Competition

The approval of novel drug delivery mechanisms for nifedipine can revive revenue streams for pharmaceutical companies. However, stringent regulations for the approval of new drugs remain a regulatory restraint. Companies like Pfizer, Novartis, and others covered in the market analysis are key players in this space, with strategies focused on improving patient education, adherence, and the development of new formulations[1][3].

Product Indications and Benefits

Hypertension and Angina

PROCARDIA XL is indicated for the management of chronic stable angina and hypertension. It helps lower blood pressure, reducing the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions. The extended-release formulation of PROCARDIA XL improves compliance and maintains therapeutic levels of nifedipine over a longer period[5].

Clinical Benefits

The use of PROCARDIA XL has been shown to be effective in managing blood pressure and angina symptoms without significant adverse effects on most patients. However, rare cases of serious gastrointestinal obstruction, allergic hepatitis, and other side effects have been reported. The drug's ability to decrease platelet aggregation and its moderate effect on bleeding time are also noted, though these have not been clinically significant[5].

Key Takeaways

• The nifedipine market, including PROCARDIA XL, is driven by the increasing prevalence of cardiovascular diseases and the need for effective and affordable medications.
• Extended-release formulations improve patient compliance and treatment outcomes.
• Generic competition affects pricing, but technological advancements and new formulations can revive revenue streams.
• Emerging markets and healthcare infrastructure development are key growth drivers.
• The market is expected to grow significantly, with North America and the Asia-Pacific region being major contributors.

FAQs

What is the projected growth rate of the nifedipine market?

The nifedipine market is projected to grow at a CAGR of 9.4% from 2023 to 2030[1].

Which region is the largest market for nifedipine?

North America, particularly the U.S., represents the largest market for nifedipine due to high rates of hypertension[4].

How does the extended-release formulation of PROCARDIA XL benefit patients?

The extended-release formulation of PROCARDIA XL improves patient compliance by reducing the number of daily doses and maintaining therapeutic levels of nifedipine over a longer period[5].

What are the potential cost savings of switching from Procardia XL to Adalat CC?

Switching patients from Procardia XL to Adalat CC can result in significant cost savings, such as more than $2.5 million annually for Medicaid patients in Pennsylvania[2].

What are the common indications for PROCARDIA XL?

PROCARDIA XL is indicated for the management of chronic stable angina and hypertension, helping to lower blood pressure and reduce the risk of cardiovascular events[5].

Sources

1. Coherent Market Insights: Nifedipine Medication Market - Price, Size, Share & Growth.
2. PubMed: The costs and effects of switching calcium channel blockers.
3. Custom Market Insights: Global Nifedipine Market Size Reach $1,661.5 Million 2032.
4. Straits Research: Nifedipine Market Size, Share, Trends, Forecast Report 2032.
5. Pfizer Medical Information: PROCARDIA® XL (nifedipine extended release tablets) Patient Information.