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Last Updated: March 20, 2025

MYCOBUTIN Drug Patent Profile


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When do Mycobutin patents expire, and when can generic versions of Mycobutin launch?

Mycobutin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MYCOBUTIN is rifabutin. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rifabutin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mycobutin

A generic version of MYCOBUTIN was approved as rifabutin by LUPIN LTD on February 24th, 2014.

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Summary for MYCOBUTIN
Drug patent expirations by year for MYCOBUTIN
Drug Prices for MYCOBUTIN

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Recent Clinical Trials for MYCOBUTIN

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SponsorPhase
University of BariPhase 3
Centre for Digestive Diseases, AustraliaPhase 2
Cadrock Pty. Ltd.Phase 2

See all MYCOBUTIN clinical trials

Pharmacology for MYCOBUTIN

US Patents and Regulatory Information for MYCOBUTIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pfizer MYCOBUTIN rifabutin CAPSULE;ORAL 050689-001 Dec 23, 1992 AB RX Yes Yes ⤷  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 1 of 1 entries

Market Dynamics and Financial Trajectory for MYCOBUTIN (Rifabutin)

Introduction

MYCOBUTIN, the brand name for the antibiotic rifabutin, is a crucial medication in the treatment and prevention of Mycobacterium avium complex (MAC) disease, particularly in patients with advanced HIV infection. This article delves into the market dynamics and financial trajectory of MYCOBUTIN, highlighting its current status, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The global rifabutin market is experiencing a significant upward trajectory. According to recent market research, the rifabutin market is anticipated to witness strong growth rates from 2023 to 2031. This growth is driven by increasing demand for effective treatments against MAC infections, especially in regions with high HIV prevalence[3].

Segmentation of the Market

The rifabutin market is segmented based on several key factors:

By Type

The market is categorized into different dosages of rifabutin, including 25 mg, 100 mg, and 150 mg capsules. The 150 mg capsule is the most commonly used dosage for the prevention and treatment of MAC disease[3].

By Application

Rifabutin is used in various healthcare settings, including pharmacies, hospitals, and clinics. The hospital segment is expected to dominate the market due to the critical nature of MAC infections and the need for close medical supervision[3].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to show significant growth due to the large patient population and increasing healthcare expenditures[3].

Key Drivers of the Market

Several factors are driving the growth of the rifabutin market:

Increasing Prevalence of HIV and MAC Infections

The rising number of patients with advanced HIV infection, particularly in developing countries, is a major driver. MAC infections are opportunistic and often affect individuals with compromised immune systems[1][4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, have increased access to rifabutin and other essential medications. This expansion in healthcare services is expected to continue, driving market growth[3].

Public-Private Partnerships

Public-private partnerships (PPPs) play a crucial role in the development and distribution of neglected-disease drugs, including rifabutin. These partnerships help in reducing costs and increasing the availability of these medications in developing countries[2].

Challenges and Restraints

Despite the positive growth trajectory, the rifabutin market faces several challenges:

Resistance and Side Effects

The emergence of resistant strains of bacteria and severe cutaneous adverse reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, are significant concerns. These issues can limit the use of rifabutin and impact market growth[1].

Regulatory and Patent Considerations

Rifabutin is protected by several patents, with the latest expiring in 2034. The patent landscape can influence the market dynamics, especially as generic versions become available. Regulatory requirements and compliance also play a critical role in the market's trajectory[4].

Financial Performance and Projections

The financial performance of the rifabutin market is robust, with significant revenue growth anticipated over the forecast period.

Revenue Projections

The market is expected to generate substantial revenue, measured in USD million, across the various segments. The report predicts a continued and significant expansion from 2023 to 2031, driven by the factors mentioned above[3].

Cost-Efficiency and Pricing

The cost-efficiency of rifabutin, particularly when compared to other treatments, is a key factor. The drug is priced competitively, with a unit cost of approximately $13.01 per 150 mg capsule. This pricing strategy helps in maintaining market competitiveness[4].

Key Players and Manufacturers

Several pharmaceutical companies are involved in the production and distribution of rifabutin:

Major Manufacturers

Companies such as Pfizer, RedHill Biopharma Ltd., Lupin, Olon, and Janssen Pharma are prominent players in the rifabutin market. These companies contribute significantly to the market's growth through their manufacturing and distribution capabilities[3].

Conclusion

The market for MYCOBUTIN (rifabutin) is poised for significant growth driven by increasing demand, advancements in healthcare infrastructure, and public-private partnerships. However, challenges such as bacterial resistance and severe side effects need to be addressed to sustain this growth. The financial trajectory of the market is strong, with substantial revenue projections over the next several years.

Key Takeaways

  • The rifabutin market is expected to grow significantly from 2023 to 2031.
  • The market is driven by the increasing prevalence of HIV and MAC infections.
  • Public-private partnerships play a crucial role in the development and distribution of rifabutin.
  • Challenges include bacterial resistance and severe side effects.
  • Major pharmaceutical companies are key players in the market.

FAQs

What is MYCOBUTIN used for?

MYCOBUTIN (rifabutin) is used for the prevention and treatment of Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection[1][4].

What are the common dosages of rifabutin?

The common dosages of rifabutin include 25 mg, 100 mg, and 150 mg capsules, with the 150 mg capsule being the most commonly used[3].

What are the major challenges facing the rifabutin market?

The major challenges include the emergence of resistant bacterial strains and severe cutaneous adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis[1].

Which companies are major players in the rifabutin market?

Major players include Pfizer, RedHill Biopharma Ltd., Lupin, Olon, and Janssen Pharma[3].

What is the expected growth period for the rifabutin market?

The market is expected to grow significantly from 2023 to 2031[3].

Sources

  1. DailyMed: MYCOBUTIN- rifabutin capsule - DailyMed
  2. PLOS Medicine: A Breakthrough in R&D for Neglected Diseases: New Ways to Get New Medicines for the World’s Poorest People
  3. Market Research Intellect: Global Rifabutin Market Size, Scope And Forecast Report
  4. DrugBank: Rifabutin: Uses, Interactions, Mechanism of Action | DrugBank Online

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