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Last Updated: March 16, 2025

RIFABUTIN Drug Patent Profile


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When do Rifabutin patents expire, and what generic alternatives are available?

Rifabutin is a drug marketed by Lupin Ltd and Novitium Pharma and is included in two NDAs.

The generic ingredient in RIFABUTIN 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 Rifabutin

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

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Summary for RIFABUTIN
Drug patent expirations by year for RIFABUTIN
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Recent Clinical Trials for RIFABUTIN

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SponsorPhase
Tuberculosis Trials ConsortiumPhase 2/Phase 3
CW-Research and Management GmbHPhase 1
Gilead SciencesPhase 1

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Pharmacology for RIFABUTIN
Medical Subject Heading (MeSH) Categories for RIFABUTIN

US Patents and Regulatory Information for RIFABUTIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lupin Ltd RIFABUTIN rifabutin CAPSULE;ORAL 090033-001 Feb 24, 2014 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novitium Pharma RIFABUTIN rifabutin CAPSULE;ORAL 215041-001 Dec 17, 2021 AB RX 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 Rifabutin

Introduction

Rifabutin, a rifamycin derivative, has been a crucial drug in the prevention and treatment of Mycobacterium avium complex (MAC) infections, particularly in patients with advanced HIV infection. Here, we delve into the market dynamics and financial trajectory of rifabutin, highlighting its current status, future projections, and key factors influencing its market.

Market Size and Growth Projections

The rifabutin market is experiencing a significant upward trajectory. According to recent market reports, the rifabutin market is expected to see strong growth rates from 2023 to 2031. This growth is driven by increasing demand for effective treatments against MAC infections and other mycobacterial diseases[1].

Segmentation of the Rifabutin Market

The market is segmented based on several key factors:

  • Type: Rifabutin is available in various dosages, including 25 mg, 100 mg, and 150 mg capsules.
  • Application: The drug is used in pharmacies, hospitals, clinics, and other healthcare settings.
  • Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the rifabutin market:

  • Increasing Prevalence of HIV and MAC Infections: The ongoing need for effective prophylaxis against MAC bacteremia in AIDS patients continues to drive demand for rifabutin.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare systems, especially in developing regions, are increasing access to rifabutin and other essential medications.
  • Generic Market Expansion: The approval and launch of generic versions of rifabutin, such as the one by ANI Pharmaceuticals, are expanding market reach and reducing costs for patients[4].

Restraints and Challenges

Despite the growth potential, the rifabutin market faces several challenges:

  • Adverse Effects and Drug Interactions: Rifabutin can cause adverse effects and interacts with other drugs, which may limit its use in some patients[3].
  • Regulatory Hurdles: The approval process for new formulations or generic versions can be lengthy and subject to regulatory scrutiny.
  • Competition from Alternative Treatments: The development of new antibiotics and antitubercular drugs could potentially compete with rifabutin in the market.

Competitive Landscape

The rifabutin market is characterized by a mix of established and emerging players. Key companies include RedHill Biopharma Ltd., Pfizer, Lupin, Olon, Janssen Pharma, and ANI Pharmaceuticals, among others. These companies are engaged in various strategies such as product launches, partnerships, and mergers and acquisitions to strengthen their market presence[1].

Financial Performance and Projections

The financial performance of the rifabutin market is robust, with significant revenue growth anticipated:

  • Revenue Projections: The market is expected to grow substantially in terms of revenue, measured in USD million, across the forecast period from 2023 to 2031.
  • Generic Market Impact: The entry of generic versions, such as ANI Pharmaceuticals' 150 mg rifabutin capsules, is expected to contribute to the market's financial growth by increasing competition and reducing prices, making the drug more accessible to a wider patient base[4].

Market Outlook

The market outlook for rifabutin is positive, driven by both internal and external factors:

  • Internal Dynamics: Drivers such as increasing demand and advancements in healthcare infrastructure are expected to continue driving market growth.
  • External Factors: Macro-economic conditions, regulatory environments, and the competitive landscape will also play crucial roles in shaping the market's future[1].

Clinical and Therapeutic Significance

Rifabutin's clinical significance cannot be overstated:

  • Prevention of MAC Bacteremia: Rifabutin is the only drug proven to be effective in preventing MAC bacteremia in AIDS patients, making it a critical component of HIV treatment regimens[3].
  • Pharmacokinetics and Safety: Rifabutin has a favorable pharmacokinetic profile and induces hepatic enzymes to a lesser extent than rifampin, although dosage adjustments may be necessary for interacting drugs[3].

Key Players and Their Strategies

Key players in the rifabutin market are adopting various strategies to maintain and expand their market share:

  • Product Development: Companies are focusing on developing new formulations and generic versions to cater to different market segments.
  • Partnerships and Collaborations: Strategic partnerships and collaborations are being formed to enhance research and development capabilities and expand market reach[1].

Regional Analysis

The rifabutin market varies significantly across different regions:

  • North America and Europe: These regions have well-established healthcare systems and a high demand for rifabutin due to the prevalence of HIV and MAC infections.
  • Asia-Pacific and South America: These regions are expected to see significant growth due to improving healthcare infrastructure and increasing access to medications[1].

Regulatory Environment

The regulatory environment plays a crucial role in the rifabutin market:

  • FDA Approvals: Recent approvals, such as the one granted to ANI Pharmaceuticals for their generic rifabutin capsules, highlight the regulatory support for expanding access to this drug[4].
  • Compliance and Safety Standards: Companies must adhere to stringent regulatory standards to ensure the safety and efficacy of rifabutin products.

Future Trends and Opportunities

The future of the rifabutin market looks promising with several trends and opportunities on the horizon:

  • Increasing Focus on Generic and Biosimilar Drugs: The trend towards generic and biosimilar drugs is expected to continue, making rifabutin more accessible and affordable.
  • Advancements in Drug Delivery Systems: Innovations in drug delivery systems could enhance the efficacy and patient compliance of rifabutin treatments.

Key Takeaways

  • The rifabutin market is poised for significant growth from 2023 to 2031.
  • Key drivers include increasing demand for MAC infection treatments and the expansion of generic markets.
  • The market is segmented by type, application, and geography.
  • Major players are adopting strategies such as product development and partnerships to maintain market share.
  • Regulatory approvals and compliance are critical for market growth.

FAQs

What is rifabutin used for?

Rifabutin is primarily used for the prevention of Mycobacterium avium complex (MAC) infections in patients with advanced HIV infection[3].

Who are the key players in the rifabutin market?

Key players include RedHill Biopharma Ltd., Pfizer, Lupin, Olon, Janssen Pharma, and ANI Pharmaceuticals, among others[1].

What are the different dosages of rifabutin available?

Rifabutin is available in 25 mg, 100 mg, and 150 mg capsules[1].

How does the generic market impact the rifabutin market?

The generic market expands access to rifabutin by reducing costs and increasing competition, making the drug more affordable for patients[4].

What are the potential side effects of rifabutin?

Rifabutin can cause adverse effects and interacts with other drugs, which may require dosage adjustments[3].

Sources

  1. Market Research Intellect, Global Rifabutin Market Size, Scope And Forecast Report, December 2024.
  2. Vertex Pharmaceuticals, Vertex Reports Third-Quarter 2017 Financial Results, October 25, 2017.
  3. PubMed, Rifabutin: a review with emphasis on its role in the prevention of MAC bacteremia in AIDS patients, 1994.
  4. ANI Pharmaceuticals, ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Rifabutin Capsules USP, December 21, 2021.

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