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Last Updated: March 17, 2025

NEBUPENT Drug Patent Profile


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Which patents cover Nebupent, and when can generic versions of Nebupent launch?

Nebupent is a drug marketed by Fresenius Kabi Usa and is included in one NDA.

The generic ingredient in NEBUPENT is pentamidine isethionate. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nebupent

A generic version of NEBUPENT was approved as pentamidine isethionate by SETON PHARMS on September 28th, 2017.

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Summary for NEBUPENT
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 1
Patent Applications: 1,663
What excipients (inactive ingredients) are in NEBUPENT?NEBUPENT excipients list
DailyMed Link:NEBUPENT at DailyMed
Drug patent expirations by year for NEBUPENT
Recent Clinical Trials for NEBUPENT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Illinois at Chicago

See all NEBUPENT clinical trials

Pharmacology for NEBUPENT
Drug ClassAntiprotozoal

US Patents and Regulatory Information for NEBUPENT

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Fresenius Kabi Usa NEBUPENT pentamidine isethionate FOR SOLUTION;INHALATION 019887-001 Jun 15, 1989 AN RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa NEBUPENT pentamidine isethionate FOR SOLUTION;INHALATION 019887-002 Mar 22, 1996 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for NebuPent

Introduction

NebuPent, or pentamidine isethionate, is an antifungal and anti-protozoal drug used primarily for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients. Here, we will delve into the market dynamics and financial trajectory of NebuPent, examining its place within the broader inhalable drugs market.

Market Context: Inhalable Drugs

The global market for inhalable drugs is experiencing significant growth, driven by increasing diagnoses of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). In 2023, this market generated a revenue of USD 32.4 billion, with a projected growth to USD 60.8 billion by 2033, at a Compound Annual Growth Rate (CAGR) of 6.5%[3].

Product Positioning

NebuPent is administered via the Respirgard® II nebulizer and is part of the inhaled anti-infectives drug class. Its efficacy in preventing PJP has been demonstrated in clinical trials, particularly with the 300 mg every four weeks dosage regimen, which reduces the risk of developing PJP by 50 to 70% compared to the 30 mg every two weeks regimen[2][4].

Clinical Efficacy and Dosage

The clinical trials for NebuPent involved 408 patients, including those with a history of PJP and other AIDS-related conditions. The results showed a significant protective effect against PJP with the higher dosage regimen, highlighting the importance of dose and frequency in the drug's efficacy[2][4].

Adverse Events and Monitoring

While NebuPent is effective, it is associated with several adverse events, including cough, decreased appetite, dizziness, fatigue, fever, and shortness of breath. Patients must be closely monitored for serious reactions, such as pancreatitis, renal dysfunction, and cardiac issues, which have been reported in post-marketing experiences[2][4].

Market Segmentation

The inhalable drugs market is segmented by product type, indication, and distribution channel. NebuPent falls under the aerosol product type and is primarily indicated for respiratory diseases, specifically PJP. The hospital pharmacy sector dominates the distribution channel, holding the largest revenue share[3].

Regional Analysis

North America leads the inhalable drugs market with a significant revenue share of 48% in 2023, driven by advanced healthcare infrastructure and a high prevalence of respiratory diseases. The Asia Pacific region is expected to experience the highest CAGR during the forecast period, driven by rapid urbanization and increasing healthcare expenditure[3].

Financial Trajectory

Given the growing demand for inhalable drugs and the specific niche that NebuPent fills in preventing PJP, the financial trajectory for this drug is positive. Here are some key financial insights:

  • Revenue Contribution: As part of the broader inhalable drugs market, NebuPent contributes to the overall revenue growth. The market's projected growth to USD 60.8 billion by 2033 indicates a favorable financial environment for NebuPent.
  • Market Share: While specific revenue figures for NebuPent are not provided, its efficacy and the growing need for PJP prevention suggest a stable market share within the inhaled anti-infectives segment.
  • Cost and Pricing: The cost of NebuPent, like other inhalable drugs, can be influenced by factors such as manufacturing costs, regulatory environments, and reimbursement policies. Efficient pricing strategies and favorable reimbursement policies can enhance its financial performance.

Impact of Macroeconomic and Geopolitical Factors

The growth of the inhalable drugs market, including NebuPent, is influenced by macroeconomic and geopolitical factors. Economic growth and increasing healthcare expenditure can drive demand, while economic downturns or geopolitical tensions can constrain market growth. Regulatory changes and trade policies also play a crucial role in shaping the market dynamics[3].

Competitive Landscape

NebuPent operates within a competitive landscape that includes other major pharmaceutical companies such as AstraZeneca, GSK, and Boehringer Ingelheim. The competitive environment is driven by innovation, regulatory compliance, and market access strategies[3].

Key Takeaways

  • Growing Market: The inhalable drugs market is growing at a CAGR of 6.5%, driven by increasing respiratory disease diagnoses.
  • Clinical Efficacy: NebuPent has demonstrated significant efficacy in preventing PJP, particularly with the 300 mg every four weeks dosage regimen.
  • Adverse Events: Close monitoring is required due to potential adverse events.
  • Regional Growth: North America dominates the market, while the Asia Pacific region is expected to grow rapidly.
  • Financial Trajectory: The financial outlook for NebuPent is positive, driven by market growth and specific demand for PJP prevention.

FAQs

What is NebuPent used for?

NebuPent is used for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients.

What is the most effective dosage regimen for NebuPent?

The most effective dosage regimen for NebuPent is 300 mg every four weeks, which reduces the risk of developing PJP by 50 to 70% compared to the 30 mg every two weeks regimen.

What are the common adverse events associated with NebuPent?

Common adverse events include cough, decreased appetite, dizziness, fatigue, fever, and shortness of breath. Serious reactions such as pancreatitis and renal dysfunction have also been reported.

Which region dominates the inhalable drugs market?

North America dominates the inhalable drugs market with a significant revenue share, driven by advanced healthcare infrastructure and a high prevalence of respiratory diseases.

How does the broader market growth impact NebuPent?

The growing demand for inhalable drugs, driven by increasing diagnoses of respiratory diseases, positively impacts the financial trajectory of NebuPent, contributing to its stable market share and revenue growth.

Sources

  1. Drugs.com: NebuPent: Package Insert / Prescribing Information.
  2. DailyMed: NEBUPENT- pentamidine isethionate inhalant.
  3. Market.us: Inhalable Drugs Market Size, Share, Growth.
  4. FDA: NebuPent (pentamidine isethionate) - Label.

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