You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

DIPHENYLAN SODIUM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Diphenylan Sodium is a drug marketed by Chartwell Molecular and is included in one NDA.

The generic ingredient in DIPHENYLAN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diphenylan Sodium

A generic version of DIPHENYLAN SODIUM was approved as phenytoin sodium by HIKMA on December 31st, 1969.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DIPHENYLAN SODIUM?
  • What are the global sales for DIPHENYLAN SODIUM?
  • What is Average Wholesale Price for DIPHENYLAN SODIUM?
Summary for DIPHENYLAN SODIUM
Drug patent expirations by year for DIPHENYLAN SODIUM

US Patents and Regulatory Information for DIPHENYLAN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Molecular DIPHENYLAN SODIUM phenytoin sodium CAPSULE;ORAL 080857-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Molecular DIPHENYLAN SODIUM phenytoin sodium CAPSULE;ORAL 080857-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  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 Financial Trajectory for Diphenylalanine Sodium

Last updated: July 27, 2025

Introduction

Diphenylalanine Sodium (DIPHENYLAN SODIUM) is a pharmaceutical compound primarily recognized for its role in biomedical research rather than as a conventional therapeutic agent. As a peptide building block derived from phenylalanine, its unique properties facilitate the development of nanomaterials, biomimetic structures, and targeted drug delivery systems. The evolving landscape of nanomedicine and biomaterials has positioned diphenylalanine compounds at the forefront of innovative pharmaceutical applications, influencing both market dynamics and financial trajectories within the biopharmaceutical sector.

Market Overview

The pharmaceutical and biotechnology sectors have observed a growing demand for peptide-based compounds, notably in drug delivery, nanostructure engineering, and diagnostic applications. Diphenylalanine sodium’s capacity to self-assemble into nano- and micro-scale structures offers promising avenues for research and commercial translation, although it remains predominantly in the R&D phase.

Market estimates for peptide libraries and nanomaterials utilizing DIPHENYLAN SODIUM remain modest but are projected to expand significantly in the next decade. The global nanomedicine market, valued at approximately USD 3.0 billion in 2022, is expected to grow at a CAGR of 13-15% through 2030, driven by innovations in peptide self-assembly technologies, including those involving diphenylalanine derivatives [1].

Driving Factors

Technological Advancements in Nanotechnology

Advances in nanofabrication and self-assembly techniques have propelled the utility of diphenylalanine structures. Their robust and stable nanostructures facilitate targeted drug delivery, improving bioavailability and reducing side effects. Companies investing in nanomedicine platforms now regard peptide self-assembling compounds as foundational components, increasing their market relevance.

Research and Development Funding

Major pharmaceutical firms, biotech startups, and academic institutions are dedicating substantial R&D funding to peptide-based materials. Initiatives like NIH grants and European Union research aid have accelerated the exploration of diphenylalanine’s applications, positioning it as a key molecule in next-generation therapeutics.

Emerging Applications in Oncology and Regenerative Medicine

Diphenylalanine-based nanostructures are under investigation for cancer therapy, owing to their ability to be functionalized for targeted delivery. Additionally, their use in scaffolds for tissue engineering enhances regenerative medicine developments, further diversifying their market potential.

Regulatory Landscape

Currently, DIPHENYLAN SODIUM compounds used purely as research tools face minimal regulatory hurdles. However, as commercial applications approach clinical trials, regulatory pathways for peptide nanomaterials are expected to mature, potentially influencing market entry and investment risks.

Challenges and Constraints

Despite promising prospects, several challenges temper market growth:

  • Limited Clinical Data: The paucity of clinical trial results hampers commercialization timelines.
  • Manufacturing Complexities: Consistent, scalable production of peptide nanostructures remains technically demanding and costly.
  • Intellectual Property Risks: Patent landscapes for peptide self-assembly technologies are crowded, potentially hindering development.
  • Market Penetration: Competition from alternative nanomaterials, such as liposomes and inorganic nanoparticles, may limit the immediate adoption of diphenylalanine-based systems.

Financial Trajectory and Investment Outlook

The financial prospects for diphenylalanine sodium are predominantly forward-looking, with initial revenues expected from research collaborations, licensing deals, and niche specialty chemical sales. As nanomaterials with biomedical applications transition from laboratory to clinical settings, revenue streams will likely diversify.

Investors and industry players should monitor:

  • Patent Filings: Rising patent activity indicates technological maturation and commercial interest.
  • Collaborative Agreements: Strategic alliances signal validation and funding support.
  • Funding Trends: Increased public and private sector investment in peptide nanotech translates into favorable market conditions.

Projected revenue contributions from diphenylalanine-based products are modest in the current cycle but could see exponential growth from 2025 onward, especially if clinical data supports approval pathways for innovative drug delivery systems.

Market Segments and Growth Opportunities

  • Research Reagents: Currently, the primary revenue stream, with steady growth as academic and corporate laboratories adopt diphenylalanine reagents.
  • Nanostructure Manufacturing: Contract manufacturing organizations (CMOs) are exploring large-scale production, creating new business opportunities.
  • Therapeutic Platforms: Future applications in targeted therapies—oncology, neurodegenerative diseases—may generate multi-billion dollar markets upon successful clinical translation.

Competitive Landscape

Several players, including biotech startups and established pharmaceutical companies, are exploring peptide nanostructures:

  • PeptiGel Solutions and other niche biotech firms are pioneering self-assembling peptides.
  • Major Pharma Companies are investing in nanomedicine technologies, integrating peptide frameworks into their pipelines.
  • Academic institutions contribute to foundational science, fostering innovation and patent generation.

Regulatory and Ethical Considerations

Regulatory approval processes for nanomedicine are evolving, with agencies like the FDA and EMA emphasizing safety, biological compatibility, and manufacturing standards. The pathway for diphenylalanine nanostructures hinges on demonstrating safety profiles, especially for in vivo applications, which influences investment risk and development timelines.

Key Market Drivers and Restraints Summary

Drivers Restraints
Technological innovations in peptide self-assembly Scarcity of clinical validation
Increased R&D investment in nanomedicine Manufacturing scalability challenges
Expanding applications in targeted drug delivery Regulatory uncertainties
Rising demand for biocompatible nanomaterials Competitive alternatives (liposomes, inorganic NPs)

Conclusion

Diphenylalanine sodium's trajectory hinges on its emerging role in nanomedicine and biomaterials. While presently confined largely to research and development, its potential to revolutionize drug delivery, tissue engineering, and diagnostic platforms could translate into significant commercial opportunities. The market's evolution over the next decade depends on scientific validation, scalable manufacturing, regulatory clarity, and strategic collaborations.


Key Takeaways

  • The market for diphenylalanine sodium is primarily driven by the expanding nanomedicine sector, with increasing R&D activity signaling future commercialization.
  • Technical advances in peptide self-assembly bolster the compound’s utility, propelling its role in targeted therapies and regenerative medicine.
  • Regulatory pathways for peptide nanostructures remain under development, impacting the delivery timelines for clinical applications.
  • Investment in research collaborations, patent portfolios, and scalable manufacturing capacity are critical indicators of future market growth.
  • Near-term revenues will likely accrue from research reagent sales and early-stage therapeutic platforms, with significant upside potential upon clinical validation.

FAQs

1. What are the current clinical applications of diphenylalanine sodium?
Currently, diphenylalanine sodium is predominantly used in research settings to develop nanomaterials. Clinical applications are still in the experimental phase, with ongoing studies exploring drug delivery and tissue engineering prospects.

2. How does diphenylalanine sodium compare to other nanomaterial platforms?
Diphenylalanine-based nanostructures are valued for their biocompatibility, ease of self-assembly, and structural stability. Compared to inorganic nanoparticles, they offer enhanced biodegradability, but manufacturing scalability and regulatory approval remain challenges.

3. What is the projected market size for diphenylalanine-based nanomaterials?
While there are no specific market size estimates exclusively for diphenylalanine sodium, the broader nanomedicine market’s projected growth suggests substantial expansion potential, especially as translational research progresses.

4. Are there any significant patent pools surrounding diphenylalanine nanostructures?
Yes, numerous patents address peptide self-assembly, nanostructure fabrication, and functionalization, reflecting considerable intellectual property activity that may influence licensing and commercialization strategies.

5. What are the main barriers to commercializing diphenylalanine sodium products?
Key barriers include manufacturing complexity, the need for extensive safety validation, regulatory hurdles, and competition from established nanomaterials. Addressing these factors is vital for market entry and financial success.


References

  1. MarketsandMarkets. (2023). Nanomedicine Market by Technology, Application, and Region.
  2. National Institutes of Health. (2022). Research Funding for Peptide-Based Nanomaterials.
  3. European Medicines Agency. (2024). Guidelines on Nanomedicine Development and Approval.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.