PREVACID NAPRAPAC 500 (COPACKAGED) Drug Patent Profile

When do Prevacid Naprapac 500 (copackaged) patents expire, and what generic alternatives are available?

Prevacid Naprapac 500 (copackaged) is a drug marketed by Takeda Pharms Na and is included in one NDA.

The generic ingredient in PREVACID NAPRAPAC 500 (COPACKAGED) is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for PREVACID NAPRAPAC 500 (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	PREVACID NAPRAPAC 500 (COPACKAGED) at DailyMed

US Patents and Regulatory Information for PREVACID NAPRAPAC 500 (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003		DISCN	No	No

Expired US Patents for PREVACID NAPRAPAC 500 (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	4,628,098*PED
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	5,433,959*PED
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	5,093,132*PED
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	5,045,321*PED

International Patents for PREVACID NAPRAPAC 500 (COPACKAGED)

See the table below for patents covering PREVACID NAPRAPAC 500 (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8607288
Spain	546152
Bulgaria	60415
Ireland	851976
Canada	1338399	COMPOSITION PHARMACEUTIQUE STABILISEE ET SA PREPARATION (STABILIZED PHARMACEUTICAL COMPOSITION AND ITS PRODUCTION)
Latvia	5091	Piridina atvasinajumu iegusanas metode

Supplementary Protection Certificates for PREVACID NAPRAPAC 500 (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0174726	SPC/GB94/011	United Kingdom		SPC/GB94/011, EXPIRES: 20051210
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211

PREVACID NAPRAPAC 500 (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PREVACID NAPRAPAC 500 (COPACKAGED)

Introduction

PREVACID NAPRAPAC 500 is a copackaged medication that combines lansoprazole, a proton pump inhibitor (PPI), and naproxen, a nonsteroidal anti-inflammatory drug (NSAID). This combination is designed to reduce the risk of NSAID-associated gastric ulcers. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth of the Pharmaceutical Industry

The global pharmaceutical market is vast and growing. In 2022, the market size was estimated at USD 1,482.0 billion and is expected to grow at a compound annual growth rate (CAGR) of 6.12% from 2023 to 2030[3].

Segment Dominance

The branded segment of the pharmaceutical market, which includes PREVACID NAPRAPAC 500, dominated the market with a revenue share of 67.60% in 2022. This dominance is attributed to the rising prevalence of chronic diseases, increasing R&D investments, and the approval of novel pharmaceuticals[3].

Prescription vs. OTC Segment

The prescription segment, where PREVACID NAPRAPAC 500 falls, held a dominant revenue share of 87.23% in 2022. This is due to the increasing R&D investments by major players in developing new pharmaceuticals, particularly for chronic diseases[3].

Regional Market Share

North America, with its high per capita healthcare expenditure and strong GDP, held the largest market share of 37.0% in the pharmaceuticals market in 2022. This region is expected to maintain its dominant position throughout the forecast period, which is beneficial for the sales of PREVACID NAPRAPAC 500[3].

Product Specifics and Market Position

PREVACID NAPRAPAC 500 is approved for the risk reduction of NSAID-associated gastric ulcers in adult patients with a history of documented gastric ulcers. The combination of lansoprazole and naproxen addresses a significant clinical need, particularly in patients who require long-term NSAID therapy[1].

Clinical Efficacy and Safety

Clinical studies have shown that PREVACID NAPRAPAC 500 significantly reduces the risk of gastric ulcers compared to placebo. However, it also comes with warnings regarding cardiovascular and gastrointestinal risks associated with NSAIDs, which can impact its market acceptance and usage[1].

Financial Performance

The financial performance of PREVACID NAPRAPAC 500 is tied to the broader pharmaceutical market trends. Given the dominance of the branded segment and the prescription market, this product is likely to contribute significantly to the revenue of its manufacturers. However, the high cost of prescription medications and the rising approval of OTC drugs could impact its sales. For instance, the average launch price for a new medicine in 2021 was USD 180,000 for an annual supply, which can deter some consumers[3].

Competitive Landscape

The pharmaceutical market is highly competitive, with major players constantly introducing new products. The launch of novel therapeutics, such as AstraZeneca's IMJUDO, highlights the dynamic nature of the industry. PREVACID NAPRAPAC 500 must compete with other combination therapies and generic alternatives, which can affect its market share and pricing[3].

Regulatory Environment

Regulatory changes and approvals play a crucial role in the market dynamics of pharmaceuticals. PREVACID NAPRAPAC 500 was approved in November 2003, and any changes in regulatory requirements or the approval of new competitors can impact its market position[2].

Consumer Trends and Affordability

Consumer trends, such as the shift towards self-medication with OTC drugs due to high prescription drug prices, can influence the demand for PREVACID NAPRAPAC 500. In the U.S., Americans are expected to spend an average of USD 1,300 per person on prescription medications annually, which may drive some consumers to seek more affordable alternatives[3].

Future Projections

The global oncology drugs market, while not directly related to PREVACID NAPRAPAC 500, indicates a broader trend of growth in the pharmaceutical industry. The oncology market is projected to grow significantly, reaching approximately $518.25 billion by 2032, driven by the increasing prevalence of cancer worldwide[5].

Key Drivers and Challenges

• Rising Chronic Disease Prevalence: The increasing prevalence of chronic diseases, such as gastric ulcers, drives the demand for medications like PREVACID NAPRAPAC 500.
• Regulatory Changes: Changes in regulatory environments can impact the approval and marketing of pharmaceuticals.
• Consumer Affordability: High prescription drug prices can deter consumers and drive them towards OTC alternatives.
• Generic Competition: The entry of generic drugs into the market can reduce the market share and pricing power of branded drugs like PREVACID NAPRAPAC 500[3].

Conclusion

PREVACID NAPRAPAC 500 operates within a dynamic pharmaceutical market characterized by rapid advancements, regulatory changes, and evolving consumer needs. While it addresses a significant clinical need, its financial trajectory is influenced by broader market trends, regulatory environments, and consumer affordability.

Key Takeaways

• Market Dominance: The branded segment and prescription market dominate the pharmaceutical industry.
• Clinical Efficacy: PREVACID NAPRAPAC 500 is effective in reducing NSAID-associated gastric ulcers.
• Regulatory Environment: Regulatory approvals and changes significantly impact the market position of pharmaceuticals.
• Consumer Trends: High prescription drug prices drive consumers towards OTC alternatives.
• Future Growth: The pharmaceutical industry is expected to grow, driven by increasing chronic disease prevalence and R&D investments.

FAQs

1. What is PREVACID NAPRAPAC 500 used for? PREVACID NAPRAPAC 500 is used for the risk reduction of NSAID-associated gastric ulcers in adult patients with a history of documented gastric ulcers.

2. What are the key components of PREVACID NAPRAPAC 500? The key components are lansoprazole, a proton pump inhibitor (PPI), and naproxen, a nonsteroidal anti-inflammatory drug (NSAID).

3. What are the major risks associated with PREVACID NAPRAPAC 500? The major risks include cardiovascular thrombotic events, myocardial infarction, stroke, and gastrointestinal bleeding and perforation.

4. How does the regulatory environment impact PREVACID NAPRAPAC 500? Regulatory approvals and changes can significantly impact the market position and availability of PREVACID NAPRAPAC 500.

5. What consumer trends affect the demand for PREVACID NAPRAPAC 500? High prescription drug prices and the increasing approval of OTC drugs drive consumers towards more affordable alternatives, affecting the demand for PREVACID NAPRAPAC 500.

Sources

1. FDA Label for PREVACID NapraPAC - https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021507s009lbl.pdf
2. FDA NDA for Lansoprazole - https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208025Orig1s000MedR.pdf
3. Grand View Research: Pharmaceutical Market Report - https://www.grandviewresearch.com/industry-analysis/pharmaceutical-market-report
4. Oklahoma.gov: Published Annual Reviews - https://oklahoma.gov/content/dam/ok/en/okhca/documents/a0300/15322.pdf
5. Jarsking: Analysis of the Pharmaceutical Industry Market and Trends - https://www.jarsking.com/analysis-of-the-pharmaceutical-industry-market-and-trends/