METHYLENE BLUE - Generic Drug Details

What are the generic drug sources for methylene blue and what is the scope of freedom to operate?

Methylene blue is the generic ingredient in two branded drugs marketed by Zydus Lifesciences and Provepharm Sas, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methylene blue. Three suppliers are listed for this compound.

Summary for METHYLENE BLUE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	113
Patent Applications:	6,927
Drug Prices:	Drug price trends for METHYLENE BLUE
What excipients (inactive ingredients) are in METHYLENE BLUE?	METHYLENE BLUE excipients list
DailyMed Link:	METHYLENE BLUE at DailyMed

See drug prices for METHYLENE BLUE

Recent Clinical Trials for METHYLENE BLUE

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

Sponsor	Phase
University of Rochester	Phase 2
University of Turin, Italy	Phase 2
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Phase 2

See all METHYLENE BLUE clinical trials

Pharmacology for METHYLENE BLUE

Drug Class	Oxidation-Reduction Agent
Mechanism of Action	Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for METHYLENE BLUE

Enzyme Inhibitors

US Patents and Regulatory Information for METHYLENE BLUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-002	Dec 5, 2023	AP	RX	No	No
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-002	Jul 18, 2019	AP	RX	Yes	Yes
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-001	Dec 5, 2023	AP	RX	No	No
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-001	Apr 8, 2016	AP	RX	Yes	Yes

METHYLENE BLUE Market Analysis and Financial Projection Experimental

Methylene Blue Market Dynamics and Financial Trajectory

Introduction to Methylene Blue

Methylene blue, also known as methylthioninium chloride, is a versatile compound with a wide range of applications, particularly in the pharmaceutical, medical, and chemical industries. It is used as a dye, a redox indicator, and for biological staining, among other purposes[1][3][5].

Market Size and Growth Projections

The global methylene blue market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market size was valued at approximately USD 7.66 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2030, reaching nearly USD 10.93 billion by 2030[3].

Key Drivers of the Market

Increasing Demand in Pharmaceuticals

The escalating demand for methylene blue in the pharmaceutical industry is a major driving factor. It is used in the production of medicines, particularly as an antidote for treating methemoglobinemia, and for its virucidal activity, which makes it useful as a disinfectant and antiviral medication[1][3][5].

Growing Population and Health Issues

The rise in the global population and an increase in health issues are likely to boost the demand for methylene blue. Its use in medical research and testing, especially in treating conditions like septic shock and hypoxia, further drives market growth[1][3].

Industrial Applications

Methylene blue is also used extensively in textile, chemical, and aquacultural industries. Its application in biological components experiments and as a redox agent in chemical analytics adds to its market demand[5].

Regional Insights

North America

North America is projected to lead the methylene blue market during the forecast period. The U.S. is identified as the main consumer due to the high rate of infections and illnesses, driving up demand for antiseptics and pharmaceuticals. The region's strong growth in pharmaceutical, chemical, and other industries, along with advanced R&D procedures, contributes to its dominance[3][5].

Asia Pacific

The Asia Pacific region is expected to grow at a steady CAGR during the forecast period. Countries like India, China, and Japan are major contributors due to the presence of leading key players and modern innovations in the pharmaceutical industry. The use of methylene blue in identifying microorganisms, nucleic acids, and RNA sequences in medical treatments is a significant factor in this region's growth[3][5].

Market Restraints

Side Effects and Safety Concerns

Despite its numerous benefits, methylene blue is associated with several side effects, including nausea, excessive sweating, headache, confusion, and the formation of methemoglobin. These adverse effects can restrain market growth, as they may reduce the preference for methylene blue in treatments and necessitate medical attention[1][3][5].

Dosage and Toxicity

The need for precise dosing is crucial, as overdosing can lead to severe toxic side effects, including coma and death. This risk further hampers the market's revenue growth[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the methylene blue market. While the lockdowns and supply chain disruptions negatively affected the supply of medical and pharmaceutical products, methylene blue's potential use in treating acute diseases, including COVID-19, presented new opportunities for market expansion. Leucomethylene Blue, the reduced form of methylene blue, has been considered for COVID-19 treatment, which could further boost the market[1].

Competitive Landscape

The methylene blue market is competitive, with several key players active globally. Some of the leading players include Vanshi Chemicals, BiTe Chemical, Eastman Chemical, Macsen Laboratories, Sakshi Dyes, Daiichi Sankyo, and Megha International. These companies are involved in various segments of the market, from pharmaceuticals to textiles and chemical analytics[1][3].

Emerging Trends and Opportunities

Antioxidant Properties

Methylene blue's antioxidant properties, particularly its ability to improve mitochondrial function, present opportunities for its use in treating various diseases associated with aging and mitochondrial dysfunction[4].

Virucidal and Antiviral Applications

The virucidal activity of methylene blue makes it a valuable component in the fight against viral and bacterial infections. Its use as a disinfectant and antiviral medication is expected to drive market growth[5].

Innovations in Medical Treatments

Recent studies and innovations, such as the use of methylene blue in sentinel lymph node biopsies for early breast cancer, highlight its potential in advanced medical treatments. These developments are expected to increase product demand in the market[5].

Financial Trajectory

The financial trajectory of the methylene blue market is positive, driven by increasing demand and expanding applications. Here are some key financial highlights:

• Market Size in 2023: USD 7.66 billion[3].
• Projected Market Size by 2030: Nearly USD 10.93 billion[3].
• CAGR from 2024 to 2030: 5.2%[3].

Key Takeaways

• The methylene blue market is driven by its increasing demand in pharmaceuticals, growing population, and health issues.
• North America is expected to lead the market, followed by the Asia Pacific region.
• Side effects and safety concerns are significant restraints.
• The COVID-19 pandemic presented both challenges and opportunities for the market.
• Emerging trends include its antioxidant properties and virucidal applications.
• The market is expected to grow at a CAGR of 5.2% from 2024 to 2030.

FAQs

What is the current market size of the global methylene blue market?

The global methylene blue market was valued at approximately USD 7.66 billion in 2023[3].

What is the projected growth rate of the methylene blue market from 2024 to 2030?

The methylene blue market is expected to grow at a CAGR of 5.2% from 2024 to 2030[3].

Which region is expected to lead the methylene blue market during the forecast period?

North America is projected to lead the methylene blue market during the forecast period[3][5].

What are the primary applications of methylene blue?

Methylene blue is used in pharmaceuticals, textiles, biological components experiments, and as a redox agent in chemical analytics[1][3][5].

What are the major side effects associated with methylene blue?

The major side effects include nausea, excessive sweating, headache, confusion, and the formation of methemoglobin[1][3][5].

How has the COVID-19 pandemic impacted the methylene blue market?

The pandemic has had a mixed impact, with supply chain disruptions but also potential new uses in treating COVID-19[1].

Sources

1. Allied Market Research - Methylene Blue Market Size, Share | Industry Growth & Forecast 2027
2. Market Research Intellect - Pharmacopoeial Grade Methylene Blue Market Size And Projection
3. Maximize Market Research - Methylene Blue Market: Global Industry Analysis and Forecast
4. Aging-US - Targeting mitochondrial dysfunction using methylene blue or ...
5. Reports and Data - Methylene Blue Market Size, Growth Driver, and Analysis 2030