PREVACID NAPRAPAC 375 (COPACKAGED) Drug Patent Profile

Which patents cover Prevacid Naprapac 375 (copackaged), and what generic alternatives are available?

Prevacid Naprapac 375 (copackaged) is a drug marketed by Takeda Pharms Na and is included in one NDA.

The generic ingredient in PREVACID NAPRAPAC 375 (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 375 (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	PREVACID NAPRAPAC 375 (COPACKAGED) at DailyMed

US Patents and Regulatory Information for PREVACID NAPRAPAC 375 (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 375 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-003	Nov 14, 2003		DISCN	No	No

International Patents for PREVACID NAPRAPAC 375 (COPACKAGED)

See the table below for patents covering PREVACID NAPRAPAC 375 (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8607288
Spain	546152
Bulgaria	60415
Ireland	851976

Supplementary Protection Certificates for PREVACID NAPRAPAC 375 (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 375 (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prevacid NapraPAC 375

Introduction

Prevacid NapraPAC 375 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 in patients with a history of gastric ulcers who require ongoing NSAID therapy.

Market Need and Target Population

Prevacid NapraPAC 375 addresses a significant medical need by mitigating the gastrointestinal risks associated with long-term NSAID use. The target population includes patients with conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis who are at risk of developing gastric ulcers due to NSAID therapy[3].

Competitive Landscape

The market for gastrointestinal protective agents and NSAIDs is highly competitive. Prevacid NapraPAC 375 competes with other combination therapies and standalone NSAIDs and PPIs. The entry of generic versions of similar medications can significantly impact the market share and pricing of branded products like Prevacid NapraPAC 375[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products. Prevacid NapraPAC 375 is subject to FDA regulations, and any changes in these regulations or the approval of generic versions can affect its market position. For instance, the FDA's approval of generic versions of Prevacid SoluTab has introduced competition in the PPI market[2].

Pricing and Revenue

The pricing of Prevacid NapraPAC 375 is influenced by several factors, including production costs, market demand, and competition from generic alternatives. The cost of the medication can be significant, especially for patients requiring long-term therapy. However, the combination of an NSAID and a PPI in one package can offer convenience and potentially reduce overall healthcare costs by preventing costly gastrointestinal complications[3].

Financial Trajectory

Historical Performance

Prevacid NapraPAC 375 has been a revenue-generating product for its manufacturers, particularly before the advent of generic competition. The product's financial performance has been impacted by the expiration of patents and the subsequent entry of generic versions.

Impact of Generic Competition

The introduction of generic versions of lansoprazole and naproxen has led to a decline in the market share and revenue of Prevacid NapraPAC 375. Generic manufacturers can offer lower-priced alternatives, which attract price-sensitive consumers and reduce the market share of branded products[2].

Strategic Responses

To maintain market share, the manufacturers of Prevacid NapraPAC 375 may employ various strategies, such as:

• Marketing and Promotion: Enhanced marketing efforts to highlight the benefits of the combination therapy.
• Patient Assistance Programs: Offering discounts or assistance programs to make the medication more affordable.
• Innovative Packaging: Improving the packaging to enhance patient compliance and convenience.
• Litigation and Patent Protection: Engaging in legal battles to protect patents and delay the entry of generic competitors[2].

Risks and Challenges

Cardiovascular and Gastrointestinal Risks

Prevacid NapraPAC 375 carries significant risks, including cardiovascular thrombotic events and gastrointestinal bleeding or perforation. These risks can impact patient adherence and overall market demand, especially if safer alternatives become available[1][3].

Regulatory Scrutiny

The product is under regulatory scrutiny due to its potential side effects. Any adverse regulatory actions or changes in labeling requirements can negatively impact sales and revenue.

Market Exclusion

In some cases, the product may be excluded from formularies or preferred drug lists due to cost considerations or doubts about its value, as seen in the case of the U.S. Department of Defense's formulary decisions[4].

Market Trends and Future Outlook

Increasing Generic Competition

The trend of increasing generic competition is expected to continue, putting pressure on the pricing and market share of branded products like Prevacid NapraPAC 375.

Biosimilars and New Therapies

The emergence of biosimilars and new therapeutic options could further erode the market share of traditional NSAIDs and PPIs.

Patient Safety and Compliance

There is a growing emphasis on patient safety and compliance, which may lead to increased adoption of combination therapies that offer both efficacy and gastrointestinal protection.

Key Takeaways

• Prevacid NapraPAC 375 addresses a significant medical need by reducing the risk of NSAID-associated gastric ulcers.
• The product faces intense competition from generic versions and other combination therapies.
• Regulatory and market dynamics significantly influence the financial trajectory of the product.
• Manufacturers must employ strategic responses to maintain market share in a competitive environment.
• Patient safety and compliance are critical factors in the ongoing market dynamics.

FAQs

What is Prevacid NapraPAC 375 used for?

Prevacid NapraPAC 375 is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis while reducing the risk of stomach ulcers associated with NSAID use[3].

What are the main components of Prevacid NapraPAC 375?

The main components are lansoprazole, a proton pump inhibitor, and naproxen, a nonsteroidal anti-inflammatory drug[3].

What are the potential side effects of Prevacid NapraPAC 375?

Potential side effects include cardiovascular risks such as heart attack or stroke, gastrointestinal bleeding or perforation, and other less severe side effects like mild stomach pain and headache[3].

How does the combination of lansoprazole and naproxen work?

Lansoprazole decreases the amount of acid produced in the stomach, while naproxen reduces substances in the body that cause inflammation, pain, and fever[3].

What impact does generic competition have on Prevacid NapraPAC 375?

Generic competition significantly reduces the market share and revenue of Prevacid NapraPAC 375 by offering lower-priced alternatives, attracting price-sensitive consumers[2].

Sources

1. FDA Label: PREVACID NapraPAC - accessdata.fda.gov
2. FTC Report: Overview of FTC Actions in Pharmaceutical Products and Distribution - ftc.gov
3. Drugs.com: Prevacid NapraPAC - drugs.com
4. Health.mil: Cumulative Minutes 2004 - health.mil