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Last Updated: December 22, 2024

MYAMBUTOL Drug Patent Profile


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

Myambutol is a drug marketed by Kanchan Hlthcare and is included in one NDA.

The generic ingredient in MYAMBUTOL is ethambutol hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Myambutol

A generic version of MYAMBUTOL was approved as ethambutol hydrochloride by EPIC PHARMA LLC on November 30th, 1999.

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

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Recent Clinical Trials for MYAMBUTOL

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

SponsorPhase
Singapore Immunology NetworkPhase 2
A*STAR Infectious Diseases LabsPhase 2
University of Massachusetts, WorcesterPhase 2

See all MYAMBUTOL clinical trials

US Patents and Regulatory Information for MYAMBUTOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kanchan Hlthcare MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Kanchan Hlthcare MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Kanchan Hlthcare MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Kanchan Hlthcare MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MYAMBUTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYAMBUTOL

Introduction to MYAMBUTOL

MYAMBUTOL, also known as ethambutol hydrochloride, is an oral chemotherapeutic agent specifically effective against actively growing microorganisms of the genus Mycobacterium, including Mycobacterium tuberculosis, the causative agent of tuberculosis (TB)[3][4].

Market Context: Tuberculosis Treatment Drugs

The global tuberculosis treatment drugs market is experiencing significant growth, driven by several key factors. The market size was valued at $1.9 billion in 2021 and is projected to reach $3.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.3% from 2022 to 2031[1].

Key Drivers of Market Growth

  1. Rise in Drug-Resistant TB Cases: The increasing incidence of drug-resistant TB strains is a major driver for the growth of the tuberculosis treatment drugs market. This has necessitated the development and use of effective antituberculous drugs like MYAMBUTOL[1].

  2. Government Initiatives: Government initiatives aimed at eliminating TB are another significant factor. These initiatives often include public health programs that increase the demand for TB treatment drugs[1].

  3. Research Activities: Ongoing research and development in anti-tuberculosis medications also fuel the market growth. New regimens and combination therapies involving drugs like MYAMBUTOL are being explored and implemented[1].

Market Segmentation

  • Disease Type: The active tuberculosis segment dominated the market in terms of revenue in 2021. MYAMBUTOL is primarily used in the treatment of active TB[1].

  • Therapy Type: The first-line therapy segment, which includes drugs like MYAMBUTOL, dominated the market in terms of revenue in 2021. MYAMBUTOL is often used in conjunction with other antituberculous drugs as part of first-line therapy[1].

  • Distribution Channel: The drug stores and retail pharmacies segment dominated the market in terms of revenue in 2021. However, the online providers segment is anticipated to grow at the highest CAGR during the forecast period, which could impact the distribution dynamics of MYAMBUTOL[1].

Financial Trajectory

  • Market Size and Growth: As part of the broader tuberculosis treatment drugs market, MYAMBUTOL contributes to the overall market size. The projected growth to $3.2 billion by 2031 indicates a robust financial trajectory for drugs like MYAMBUTOL[1].

  • Revenue Streams: The revenue generated from MYAMBUTOL is part of the larger revenue streams from antituberculous drugs. The dominance of the first-line therapy segment and the active tuberculosis segment ensures a steady revenue stream for MYAMBUTOL[1].

Competitive Landscape

The market for tuberculosis treatment drugs, including MYAMBUTOL, is competitive with several key players:

  • Lupin
  • Sanofi
  • Pfizer Inc.
  • Fresenius SE & Co. KGaA (Fresenius Kabi)
  • Johnson & Johnson
  • Novartis AG
  • Macleods Pharmaceuticals Ltd.
  • ANI Pharmaceuticals, Inc.
  • Otsuka Pharmaceutical Co., Ltd.
  • Teva Pharmaceutical Industries Ltd.[1]

Regional Outlook

The market for tuberculosis treatment drugs, including MYAMBUTOL, is segmented by region:

  • North America: This region is the largest market for TB treatment drugs.
  • Europe: Countries like the UK, Germany, France, Spain, and Italy contribute significantly.
  • Asia-Pacific: Countries such as China, Japan, India, Australia, and South Korea are key markets.
  • LAMEA (Latin America, Middle East, and Africa): Countries like Brazil, South Africa, Turkey, and Saudi Arabia also play a crucial role[1].

Challenges and Opportunities

  • Drug Resistance: The development of resistance to MYAMBUTOL and other antituberculous drugs is a significant challenge. However, this also presents an opportunity for the development of new combination therapies and second-line treatments[3][4].

  • Regulatory Environment: Strict regulatory requirements and the need for continuous monitoring of drug efficacy and safety can be both a challenge and an opportunity for pharmaceutical companies to innovate and comply with evolving standards.

Clinical and Pharmacological Aspects

MYAMBUTOL is effective against strains of Mycobacterium tuberculosis and is used in conjunction with other antituberculous drugs. It inhibits the synthesis of one or more metabolites, causing impairment of cell metabolism, arrest of multiplication, and cell death. The drug does not show cross-resistance with other available antimycobacterial agents[3][4].

Adverse Reactions and Safety

MYAMBUTOL can cause several adverse reactions, including visual disturbances, hypersensitivity reactions, and gastrointestinal issues. Monitoring visual acuity is crucial during treatment, and the drug should not be used as the sole antituberculous agent[3][4].

Key Takeaways

  • The global tuberculosis treatment drugs market, including MYAMBUTOL, is projected to grow significantly.
  • Key drivers include the rise in drug-resistant TB cases, government initiatives, and ongoing research activities.
  • MYAMBUTOL is primarily used in first-line therapy for active TB.
  • The market is competitive with several major pharmaceutical companies involved.
  • Regional markets, especially North America, are significant contributors to the revenue.

Frequently Asked Questions (FAQs)

Q1: What is MYAMBUTOL used for? MYAMBUTOL (ethambutol hydrochloride) is used for the treatment of pulmonary tuberculosis, typically in conjunction with other antituberculous drugs[3][4].

Q2: How does MYAMBUTOL work? MYAMBUTOL inhibits the synthesis of one or more metabolites in Mycobacterium tuberculosis, causing impairment of cell metabolism, arrest of multiplication, and cell death[3][4].

Q3: What are the common adverse reactions associated with MYAMBUTOL? Common adverse reactions include visual disturbances, hypersensitivity reactions, dermatitis, pruritus, joint pain, anorexia, nausea, and vomiting[3][4].

Q4: Can MYAMBUTOL be used alone for TB treatment? No, MYAMBUTOL should not be used as the sole antituberculous drug. It should be used in conjunction with at least one other antituberculous drug[3][4].

Q5: What is the projected market size for tuberculosis treatment drugs by 2031? The global tuberculosis treatment drugs market is projected to reach $3.2 billion by 2031[1].

Sources Cited

  1. PharmiWeb: Tuberculosis Treatment Drugs to Record Remarkable Growth, Projected to Reach $3.2 Billion by 2031.
  2. Washoe County District Board of Health Meeting Packet: This source was not directly relevant to the topic of MYAMBUTOL.
  3. FDA Label for MYAMBUTOL: MYAMBUTOL ethambutol hydrochloride.
  4. FDA Label for MYAMBUTOL: MYAMBUTOL (ethambutol hcl) tablets.
  5. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: This source was not directly relevant to the topic of MYAMBUTOL.

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