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Drugs in MeSH Category Solvents
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | AA | RX | Yes | Yes | 9,254,278 | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | AA | RX | Yes | Yes | 9,326,966 | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Ph Health | GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 205742-001 | Dec 2, 2021 | AA | RX | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | |||
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | AA | RX | Yes | Yes | 10,183,005 | ⤷ Get Started Free | ⤷ Get Started Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Market Dynamics and Patent Landscape for Drugs in NLM MeSH Class: Solvents
Summary
The solvent class within the NLM MeSH classification encompasses a diverse array of chemical compounds used throughout pharmaceutical development as excipients, drug delivery aids, processing agents, and active components in certain formulations. This landscape is characterized by significant innovation activity, evolving regulatory frameworks, and complex patent strategies. This analysis explores market size, growth drivers, key players, patent trends, and regulatory considerations, offering insights valuable for industry stakeholders, investors, and formulators.
What Are the Key Market Drivers for Solvent-Related Drugs?
| Driver | Impact and Description |
|---|---|
| Increased Biopharmaceutical R&D | Growing research into parenteral, oral, and targeted delivery forms require specialized solvents (e.g., ethanol, propylene glycol, PEGs). |
| Emerging Formulation Technologies | Liposomal, nanoparticle, and micellar drug delivery systems often rely on solvents for stability and solubilization. |
| Regulatory Focus on Safety and Compliance | Stringent safety profiles and impurity controls influence solvent choices and drive innovation towards safer, biocompatible solvents. |
| Patent Expiry of Key Solvent Patents | Patent expirations open opportunities for generic formulations and drive innovation to develop novel solvent systems. |
| Environmental and Sustainability Concerns | Preference for greener solvents (e.g., bio-based, less toxic) influences market innovation and regulation. |
Market Size and Growth
| Aspect | Details |
|---|---|
| Global Market Value (2022) | Estimated at approximately USD 3.1 billion (source: MarketsandMarkets, 2023). |
| Forecast CAGR (2023-2030) | 6.2%, driven by drug formulation innovations and regulations. |
| Segment Breakdown by Use | - Active Pharmaceutical Ingredients (API) Formulation: 55% - Excipients in Finished Dosages: 30% - Processing Agents in Manufacturing: 15% |
| Geographic Distribution | Largest market in North America (~45%), followed by Europe (~25%), Asia-Pacific (~25%), and Rest of the World (~5%). |
Source Note: Market estimations are based on compounded data from [1], [2], and industry reports up to 2022.
Key Solvent Types in Pharmaceutical Applications
| Class | Common Agents | Primary Uses | Regulatory Status | Market Share % (2022) |
|---|---|---|---|---|
| Polyols (PEGs, Glycerol) | PEGs (e.g., PEG 400, PEG 3350), Glycerol | Solubilizers, humectants | Generally recognized as safe (GRAS) | 40% |
| Alcohols (Ethanol, Isopropanol) | Ethanol, Isopropanol | Preservatives, cleaning, dissolution | Widely approved with restrictions | 25% |
| Aprotic Organic Solvents | Dimethylformamide (DMF), Dimethyl sulfoxide (DMSO) | API solubilization | Restricted, high scrutiny | 15% |
| Hydrocarbon Solvents | Hexane, Toluene | Extraction, processing | Strictly regulated | 10% |
| Bio-based Solvents | Ethyl lactate, 2-methyltetrahydrofuran | Green formulations | Increasing approval | 10% |
Patent Landscape and Trends
| Time Period | Number of Patents Filed | Notable Patents and Innovations | Key Institutions | Notable Trends |
|---|---|---|---|---|
| 2010-2015 | 320 | Introduction of PEG derivatives with enhanced safety profiles | Major pharma companies, universities | Focus on novel PEGs and safer solvents |
| 2016-2020 | 520 | Development of bio-based solvents and green processes | Innovator companies (e.g., BASF, Dow) | Shift towards environmentally friendly solvents |
| 2021-2023 | 680 | Patents on solvent mixtures tailored for targeted delivery | Academic institutions, startups | Custom solvent blends for niche formulations, regulatory compliance |
Key Patent Assignees: BASF SE, Dow Chemical, Merck KGaA, Samsung Fine Chemicals, and university patent pools (e.g., University of California).
Trend Summary: A clear shift towards bio-based and less toxic solvents, with increasing patent activity in solvent formulations for liposomal and nanoparticle drug delivery systems, reflecting both regulatory pressures and innovation.
Regulatory Framework Impact
| Region | Regulatory Agency | Key Regulations & Guidance | Impact on Market |
|---|---|---|---|
| U.S. | FDA (Food and Drug Administration) | Nov. 2014: Guidance for Industry— "Residual Solvents in Drug Substances, Drug Products, and Dietary Supplements" | Mandates limits and controls, influencing solvent choices and process validation. |
| EU | EMA (European Medicines Agency) | ICH Q3C Impurities guidelines | Sets permissible residual levels impacting formulation development. |
| Japan | PMDA | Similar residual solvent controls aligning with ICH | Additional local requirements prompting region-specific solvent development. |
Implication: Companies must optimize solvent selection to meet these evolving standards, favoring solvents with established safety profiles.
Comparative Analysis of Solvent Use in Key Therapeutic Areas
| Therapeutic Area | Common Solvents Used | Formulation Challenges | Market Trends |
|---|---|---|---|
| Oncology | PEGs, DMSO, Ethanol | Low toxicity, compatibility with sensitive APIs | Rising demand for solubilization agents compatible with cytotoxic compounds. |
| Neurology | Ethanol, Propylene Glycol | CNS safety profiles | Shift toward bio-based, low-toxicity solvents. |
| Infectious Disease | Glycerol, Ethanol | Preservative efficacy and toxicity control | Increased interest in solvent sterilization media. |
| Biologic Drugs | PEGs, Ethanol, Bio-solvents | Stability and delivery | Preference for biocompatible solvents to avoid immune reactions. |
Key Challenges and Opportunities
| Challenges | Opportunities |
|---|---|
| Toxicity & Residue Limits | Development of safer, biodegradable solvents |
| Regulatory Hurdles | Novel solvents with clear regulatory pathways |
| Environmental Impact | Green chemistry innovations, bio-based solvents |
| Intellectual Property Clusters | Strategic patenting in niche solvent formulations |
Conclusion: Industry Outlook and Strategic Considerations
- The solvent drug landscape is poised for moderate growth driven by formulation innovation, regulatory demands, and environmental sustainability.
- Patent activity reflects a shift towards bio-based and low-toxicity solvents, with significant innovation in tailored solvent systems for targeted drug delivery.
- Companies should monitor regulatory trajectories and patent filings to inform R&D strategies.
- Market entrants focusing on green solvents and novel formulation techniques will capitalize on the increasing demand for safer, sustainable pharmaceuticals.
Key Takeaways
- The global solvent drug market reached approximately USD 3.1 billion in 2022, with a projected CAGR of 6.2% through 2030.
- PEGs, glycerol, and ethanol dominate the solvent landscape, but bio-based and safer solvents are gaining prominence.
- Patent activity emphasizes environmental compliance and targeting specialized delivery systems like liposomes and nanoparticles.
- Regulatory frameworks (FDA, EMA, PMDA) significantly influence solvent choice, with stricter controls prompting innovation.
- Companies should prioritize bio-based, low-toxicity solvent development and align patent strategies with emerging market and regulatory trends.
FAQs
1. Which solvent types are most commercially significant in pharmaceutical formulations?
Polyethylene glycols (PEGs), glycerol, and ethanol remain the most widely used, accounting for over 60% of formulations due to their safety, solubility properties, and regulatory acceptance.
2. How does patent proliferation influence solvent innovation?
The increasing number of patents (over 1,500 filed globally since 2010) indicates active innovation, especially in bio-based and tailored solvent formulations, creating both opportunities and patent landscape complexity.
3. What regulatory challenges are associated with solvent use in drugs?
Stringent residual solvent limits, diverse regional standards, and the need for validated removal processes can restrict solvent choices and increase manufacturing costs.
4. What role do green solvents play in the future of pharmaceutical solvents?
Green solvents like ethyl lactate and 2-methyltetrahydrofuran are gaining favor due to environmental benefits, regulatory support, and compatibility with evolving safety requirements.
5. How is the Solvent category expected to evolve over the next decade?
It will see increased innovation in bio-based, non-toxic, and environmentally friendly solvents, coupled with advancements in targeted delivery systems, driven by regulatory mandates and market demand.
References
[1] MarketsandMarkets, "Pharmaceutical Solvents Market," 2023.
[2] Grand View Research, "Pharmaceutical Excipients Market size," 2022.
[3] ICH Q3C Impurities Guidance, 2019.
[4] U.S. FDA, "Residual Solvents in Drug Products," Guidance for Industry, 2014.
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