PREVACID NAPRAPAC 250 (COPACKAGED) Drug Patent Profile

Which patents cover Prevacid Naprapac 250 (copackaged), and when can generic versions of Prevacid Naprapac 250 (copackaged) launch?

Prevacid Naprapac 250 (copackaged) is a drug marketed by Takeda Pharms Na and is included in one NDA.

The generic ingredient in PREVACID NAPRAPAC 250 (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 250 (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	PREVACID NAPRAPAC 250 (COPACKAGED) at DailyMed

US Patents and Regulatory Information for PREVACID NAPRAPAC 250 (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 250 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-002	Nov 14, 2003		DISCN	Yes	No

International Patents for PREVACID NAPRAPAC 250 (COPACKAGED)

See the table below for patents covering PREVACID NAPRAPAC 250 (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 250 (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 250 (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prevacid NapraPAC 250 (COPACKAGED)

Introduction

Prevacid NapraPAC 250 is a copackaged medication combining 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 documented gastric ulcers. Here, we will delve into the market dynamics and financial trajectory of this medication.

Indications and Uses

Prevacid NapraPAC 250 is indicated for patients who require ongoing NSAID therapy and have a history of gastric ulcers. The lansoprazole component helps in reducing stomach acid, while naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis[4][5].

Market Demand

The demand for Prevacid NapraPAC 250 is driven by the need for effective management of NSAID-associated gastric ulcers. Patients with chronic conditions requiring long-term NSAID use are the primary target market. The prevalence of arthritis and other inflammatory conditions contributes to a steady demand for this medication.

Competitive Landscape

The market for gastrointestinal protective agents and NSAIDs is highly competitive. Prevacid NapraPAC 250 competes with other PPI-NSAID combinations as well as standalone PPIs and NSAIDs. The competitive landscape is influenced by generic entries, which can significantly impact the market share and pricing of branded products.

Pricing and Cost Considerations

The pricing of Prevacid NapraPAC 250 is influenced by several factors, including production costs, regulatory approvals, and market competition. In some healthcare systems, the cost of this medication can be substantial. For example, in certain state Medicaid programs, the total amount paid for similar medications can range from a few hundred to several thousand dollars per year, depending on the dosage and frequency of use[1].

Financial Performance

The financial performance of Prevacid NapraPAC 250 can be gauged from various perspectives:

Revenue

The revenue generated by Prevacid NapraPAC 250 is significant due to its widespread use. However, the exact revenue figures are not publicly disclosed. Instead, we can look at broader trends in pharmaceutical spending. For instance, in 2019, the total amount paid for pharmaceuticals under certain Medicaid programs was nearly $1 billion per month, with a significant portion attributed to gastrointestinal and anti-inflammatory medications[2].

Rebates and Discounts

Pharmaceutical companies often negotiate rebates and discounts with payers to increase market penetration. These rebates can significantly impact the net revenue of the medication. For example, quarterly rebate invoices for pharmaceuticals can range from hundreds of millions to billions of dollars, indicating the substantial discounts provided to maintain market share[2].

Regulatory and Legal Impacts

Regulatory actions and legal settlements can also affect the financial trajectory of a medication. For instance, anticompetitive practices, such as reverse payments to delay generic entry, can lead to significant financial penalties. Companies like Teva Pharmaceutical Industries have faced billion-dollar settlements for such practices, which can impact their financial health and the pricing strategies of their products[3].

Side Effects and Safety Concerns

The safety profile of Prevacid NapraPAC 250, particularly the naproxen component, can influence its market dynamics. Serious side effects such as heart attacks, strokes, and gastrointestinal bleeding can lead to decreased prescriptions and increased scrutiny from regulatory bodies. These concerns may result in additional safety measures, labeling changes, or even legal actions, all of which can affect the medication's financial performance[4].

Generic Competition

The entry of generic versions of lansoprazole and naproxen can significantly impact the market share and revenue of Prevacid NapraPAC 250. Generic competition often leads to price reductions, making the branded product less competitive. This shift can result in a decline in sales and revenue for the branded medication.

Market Trends and Projections

The market for gastrointestinal protective agents and NSAIDs is expected to continue growing due to the increasing prevalence of chronic inflammatory conditions. However, the trend towards generic and biosimilar alternatives is likely to remain a significant challenge for branded products like Prevacid NapraPAC 250.

Patient Access and Affordability

Efforts to improve patient access and affordability, such as value-based pricing models and patient assistance programs, can influence the market dynamics. These initiatives can help maintain or increase market share despite generic competition.

Technological Advancements

Advancements in drug delivery systems and the development of new therapeutic agents can also impact the market. Innovations that offer better safety profiles or improved efficacy may capture market share from existing products.

Key Takeaways

• Market Demand: Driven by the need for effective management of NSAID-associated gastric ulcers.
• Competitive Landscape: Highly competitive with generic entries and other PPI-NSAID combinations.
• Pricing and Cost: Influenced by production costs, regulatory approvals, and market competition.
• Financial Performance: Impacted by rebates, discounts, regulatory actions, and generic competition.
• Safety Concerns: Serious side effects can influence prescriptions and regulatory scrutiny.
• Market Trends: Growing demand but challenged by generic competition and technological advancements.

FAQs

What is Prevacid NapraPAC 250 used for?

Prevacid NapraPAC 250 is used to reduce the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcers who require ongoing NSAID therapy.

What are the potential side effects of Prevacid NapraPAC 250?

The medication can cause serious side effects such as heart attacks, strokes, and gastrointestinal bleeding, especially with long-term use.

How does generic competition affect Prevacid NapraPAC 250?

Generic competition can significantly reduce the market share and revenue of Prevacid NapraPAC 250 by offering cheaper alternatives.

What regulatory actions can impact the financial trajectory of Prevacid NapraPAC 250?

Regulatory actions against anticompetitive practices, such as reverse payments to delay generic entry, can result in significant financial penalties.

How do rebates and discounts affect the revenue of Prevacid NapraPAC 250?

Rebates and discounts negotiated with payers can substantially reduce the net revenue of the medication, impacting its financial performance.

Sources

1. Oklahoma Health Care Authority: Published Annual Reviews.
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Meeting Documents.
3. Federal Trade Commission: Overview of FTC Actions in Pharmaceutical Products.
4. Drugs.com: Prevacid NapraPAC - Side Effects, Dosage & Uses.
5. FDA: NDA 21-507/S-005, S-007 Page 3.