NIASPAN TITRATION STARTER PACK Drug Patent Profile

When do Niaspan Titration Starter Pack patents expire, and when can generic versions of Niaspan Titration Starter Pack launch?

Niaspan Titration Starter Pack is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in NIASPAN TITRATION STARTER PACK is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Niaspan Titration Starter Pack

A generic version of NIASPAN TITRATION STARTER PACK was approved as niacin by BARR on April 14^th, 2005.

Summary for NIASPAN TITRATION STARTER PACK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	212
Patent Applications:	4,114
DailyMed Link:	NIASPAN TITRATION STARTER PACK at DailyMed

US Patents and Regulatory Information for NIASPAN TITRATION STARTER PACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997		DISCN	No	No

Expired US Patents for NIASPAN TITRATION STARTER PACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997
Abbvie	NIASPAN TITRATION STARTER PACK	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-005	Jul 28, 1997

International Patents for NIASPAN TITRATION STARTER PACK

See the table below for patents covering NIASPAN TITRATION STARTER PACK around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69829042
Australia	6454598
European Patent Office	2319513
Canada	2591710

NIASPAN TITRATION STARTER PACK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NIASPAN Titration Starter Pack

Introduction

NIASPAN, an extended-release niacin (nicotinic acid) formulation, is a crucial medication in the management of hyperlipidemia and mixed dyslipidemia. This article delves into the market dynamics and financial trajectory of the NIASPAN Titration Starter Pack, highlighting its indications, market performance, and financial implications.

Indications and Usage

NIASPAN is indicated for several key uses:

• Reducing elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia[1][3].
• Reducing the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia[1][3].
• In combination with a bile acid binding resin, it slows the progression or promotes the regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia[1].

Market Dynamics

Demand and Competition

The demand for lipid-lowering medications is high due to the prevalence of cardiovascular diseases. NIASPAN, with its unique extended-release formulation, competes in a market dominated by statins and other lipid-lowering agents. The combination therapy of NIASPAN with statins (e.g., simvastatin) has shown significant efficacy in reducing LDL-C and increasing HDL-C, making it a preferred choice for some patients[1][3].

Pricing and Cost-Effectiveness

NIASPAN is considered a less costly therapeutic alternative compared to some other lipid-lowering medications. This cost-effectiveness can influence prescribing decisions, especially in healthcare systems where cost is a significant factor[5].

Regulatory Environment

The FDA approval and subsequent updates to the prescribing information have played a crucial role in shaping the market dynamics of NIASPAN. Regulatory approvals for combination therapies, such as with lovastatin, have expanded its market reach[3].

Financial Trajectory

Revenue Performance

The financial performance of NIASPAN is closely tied to its market acceptance and the overall demand for lipid-lowering medications. In the context of Solvay's financial reports, the co-promotion of Simcor (a combination of NIASPAN and simvastatin) with Abbott Pharma has been a significant factor. The sales impact of such collaborations can be substantial, with costs related to co-promotion offset by increased revenues[2].

Research and Development

Investments in research and development (R&D) are critical for maintaining market position. The development of unique formulations, such as the NIASPAN Titration Starter Pack, which helps in minimizing flushing (a common side effect of niacin), has been a key R&D focus. This pack allows for a controlled absorption profile, enhancing patient compliance and thus contributing to the financial success of the product[4].

Market Share and Growth

The market share of NIASPAN has been influenced by its efficacy in combination therapies and its cost-effectiveness. Despite competition from other lipid-lowering agents, NIASPAN has maintained a significant market presence. The sustained growth in major product lines, including NIASPAN, has been a highlight in the financial reports of companies involved in its distribution and marketing[2].

Clinical and Economic Impact

Efficacy and Safety

Clinical trials have demonstrated the efficacy of NIASPAN in reducing cardiovascular risk factors. The combination therapy with statins has shown significant reductions in LDL-C and increases in HDL-C, which are critical for reducing cardiovascular morbidity and mortality. However, it is important to note that the addition of NIASPAN to simvastatin did not reduce cardiovascular morbidity or mortality in a large, randomized controlled trial, highlighting the need for careful patient selection and monitoring[1].

Cost-Benefit Analysis

The cost-benefit analysis of NIASPAN is favorable due to its ability to reduce long-term healthcare costs associated with cardiovascular diseases. By effectively managing lipid profiles, NIASPAN can help in reducing the incidence of myocardial infarctions, strokes, and other cardiovascular events, thereby lowering overall healthcare expenditures[5].

Challenges and Limitations

Adverse Reactions

Despite its efficacy, NIASPAN is associated with several adverse reactions, including flushing, rash, diarrhea, nausea, and vomiting. These side effects can lead to treatment discontinuation, affecting market dynamics and patient compliance[1].

Regulatory and Market Pressures

The pharmaceutical market is highly competitive and subject to regulatory pressures. Generic competition, particularly in Europe, has impacted the sales of NIASPAN. Additionally, the lack of efficacy in certain trials has raised questions about its use in combination therapies, which can influence prescribing patterns and market performance[1][2].

Future Outlook

Innovations and Formulations

The future of NIASPAN lies in continued innovation, particularly in formulation technology. The unique dissolution profile of NIASPAN, which is intermediate between immediate-release and sustained-release formulations, continues to be a selling point. Further research into minimizing side effects and enhancing patient compliance will be crucial for maintaining market share[4].

Market Expansion

Expanding into emerging markets and developing regions can provide new growth opportunities for NIASPAN. The sustained growth in these markets, as seen in Solvay's financial reports, indicates a potential for increased revenue[2].

Key Takeaways

• Indications and Usage: NIASPAN is used to manage hyperlipidemia, mixed dyslipidemia, and to reduce cardiovascular risk.
• Market Dynamics: NIASPAN competes in a competitive lipid-lowering market, with demand driven by its efficacy and cost-effectiveness.
• Financial Trajectory: Revenue performance is influenced by market acceptance, R&D investments, and regulatory approvals.
• Clinical and Economic Impact: NIASPAN has a significant impact on reducing cardiovascular risk factors and long-term healthcare costs.
• Challenges and Limitations: Adverse reactions and regulatory pressures are key challenges.
• Future Outlook: Innovations in formulation technology and market expansion into emerging regions are critical for future growth.

FAQs

What are the primary indications for NIASPAN?

NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. It is also used to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia[1].

How does the NIASPAN Titration Starter Pack work?

The NIASPAN Titration Starter Pack is designed to help patients gradually increase their dose of niacin to minimize side effects such as flushing. It allows for a controlled absorption profile, optimizing therapeutic levels of niacin[4].

What are the common adverse reactions associated with NIASPAN?

Common adverse reactions include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. These reactions can lead to treatment discontinuation in some patients[1].

How does NIASPAN impact long-term healthcare costs?

By effectively managing lipid profiles, NIASPAN can help reduce the incidence of cardiovascular events, thereby lowering overall healthcare expenditures associated with cardiovascular diseases[5].

What are the future growth prospects for NIASPAN?

Future growth prospects include innovations in formulation technology to minimize side effects and expanding into emerging markets and developing regions[2][4].

Sources

1. Drugs.com: Niaspan: Package Insert / Prescribing Information.
2. Solvay Group: Consistent implementation of our strategy for sustainable and profitable growth.
3. FDA: NIASPAN® niacin extended-release tablets.
4. Google Patents: Intermediate release nicotinic acid compositions for oral administration.
5. SAGE Journals: Efficacy and Safety Evaluation of a Large Niacin Therapeutic Alternative.