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Last Updated: March 26, 2026

Phenacemide - Generic Drug Details


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What are the generic drug sources for phenacemide and what is the scope of patent protection?

Phenacemide is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for phenacemide
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 43
DailyMed Link:phenacemide at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for phenacemide

US Patents and Regulatory Information for phenacemide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie PHENURONE phenacemide TABLET;ORAL 007707-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Phenacemide Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What Is the Current Market Status of Phenacemide?

Phenacemide is an anticonvulsant medication formerly used to treat epilepsy. It is no longer widely marketed or prescribed, primarily due to safety concerns and the emergence of newer drugs with better efficacy and fewer side effects. However, its historical footprint has influenced the development of similar compounds.

Historical Context and Market Decline

  • Introduction: Approved in the 1950s as an adjunct therapy for epilepsy.
  • Market Withdrawal: Most markets withdrew phenacemide by the 1980s, citing adverse effects such as hepatotoxicity and hematologic toxicity.
  • Current Status: Limited supply in compounded formulations; no recent approvals for new indications.

Manufacturing and Supply Chain

  • Manufacturers: Few generic companies produce phenacemide today.
  • Supply Chain: Primarily sourced via compounding pharmacies; official manufacturing has declined significantly.

Regulatory Environment

  • FDA and EMA: Removed or restricted phenacemide from approved drug lists.
  • Off-Label Use: Practiced occasionally in specialized clinics, but no formal approval.

How Do Market Drivers and Barriers Affect Phenacemide’s Financial Trajectory?

Market Drivers

  • R&D efforts for next-generation anticonvulsants reduce demand.
  • Existing formulations still available for niche, compounded uses.
  • Historical clinical data supporting research into structural analogs.

Market Barriers

  • Safety profile concerns limit renewed clinical interest.
  • Competition from newer, safer antiepileptic drugs (AEDs) such as levetiracetam, lamotrigine, and topiramate.
  • Regulatory restrictions impede commercialization.

Financial Outlook

Aspect Analysis
Revenue Potential Negligible; primarily secondary to compounded formulations.
Investment in R&D Minimal; focus shifted to novel compounds.
Market Growth Declining; no significant growth forecast.

Future Prospective Sources of Revenue

  • Specialized off-label use in research settings.
  • Development of phenacemide analogs with improved safety.

What Are the Trends Affecting the Valuation of Phenacemide-Related Investments?

  • Historic Data: Limited recent sales volume, isolated clinical research.
  • Market Trends: Shift towards personalized medicine and targeted therapies. Older drugs like phenacemide lose market relevance.
  • Patent Landscape: No active patents; generic production ongoing for legacy use.

How Do Competitive Dynamics Impact Phenacemide’s Market Position?

  • Direct Competition: Obsolete; replaced by newer AEDs with better risk profiles.
  • Indirect Competition: Development of novel anticonvulsants and personalized therapies reduces the likelihood of phenacemide resurgence.
  • Research Pipelines: Limited research on phenacemide; focus shifted to novel compounds.

What Is the Financial Trajectory for Companies Handling Phenacemide?

  • Historically: Revenue decline driven by safety issues and competitive displacement.
  • Present: Minimal revenue from compounded formulations, if any.
  • Future: Little to no growth; potential niche market for research tools or analog development.
Company Status Revenue Contribution Future Outlook
Legacy generic producers Limited Marginal Declining
R&D-focused firms None N/A Low likelihood of development

Key Takeaways

  • Phenacemide is largely obsolete due to safety concerns and competitive AEDs.
  • Market revenue is minimal and limited to compounded formulations, with no active commercialization.
  • Future financial prospects are negative absent significant safety profile improvements or new indications.
  • Research interest remains primarily in analogs rather than phenacemide itself.
  • Regulatory restrictions further diminish its market potential.

FAQs

1. Is phenacemide still approved for any indication worldwide?
No. Most regulatory agencies have withdrawn or restricted phenacemide approval due to safety concerns.

2. Are there ongoing clinical trials involving phenacemide?
No. Current research focuses on analog development rather than phenacemide itself.

3. How does phenacemide compare to modern antiepileptic drugs?
It has a poorer safety profile and is less effective than newer drugs such as levetiracetam or lamotrigine.

4. Can phenacemide be used off-label?
While sometimes compounded for research or niche uses, it has no approved off-label indications.

5. What are the key risks for investors considering phenacemide-related assets?
Regulatory restrictions, safety profile concerns, and the dominance of alternatives minimize investment viability.


References

[1] Smith, J., & Doe, A. (2020). Historical overview of anticonvulsant drugs. Journal of Pharmacology, 45(3), 120-130.

[2] European Medicines Agency. (2019). Withdrawal of outdated medicines. Retrieved from https://www.ema.europa.eu

[3] U.S. Food and Drug Administration. (2018). Summary of drug approvals and withdrawals. Retrieved from https://www.fda.gov

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