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Last Updated: March 26, 2026

EQUAGESIC Drug Patent Profile


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When do Equagesic patents expire, and what generic alternatives are available?

Equagesic is a drug marketed by Sun Pharm Industries and is included in one NDA.

The generic ingredient in EQUAGESIC is aspirin; meprobamate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; meprobamate profile page.

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Summary for EQUAGESIC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 28
DailyMed Link:EQUAGESIC at DailyMed
Drug patent expirations by year for EQUAGESIC

US Patents and Regulatory Information for EQUAGESIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries EQUAGESIC aspirin; meprobamate TABLET;ORAL 011702-003 Dec 29, 1983 DISCN No 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

Market Dynamics and Financial Trajectory for Equagesic

Last updated: February 20, 2026

What Are the Market Characteristics of Equagesic?

Equagesic is a combination drug comprising meprobamate and aspirin, historically prescribed for anxiety and pain relief. It was first introduced in the mid-20th century but has largely been phased out due to safety concerns, including dependence risks associated with meprobamate.

The drug primarily held a niche market in the United States from the 1950s to the 1980s. Today, Equagesic is classified as a withdrawn or discontinued medication in various jurisdictions, with no recent regulatory approvals or commercial manufacturing.

What Is the Regulatory Status and Its Impact on Market Potential?

Regulatory bodies, including the Food and Drug Administration (FDA), have revoked or not renewed approval for drugs with safety profiles similar to Equagesic. The Drug Enforcement Agency (DEA) classifies meprobamate as a Schedule IV controlled substance in the U.S., limiting its prescribing and distribution.

The lack of current approval restricts market re-entry. Any potential reintroduction would require comprehensive clinical trials and regulatory approval—an expensive, time-consuming process with uncertain prospects.

What Are the Competitive and Therapeutic Alternatives?

Modern therapeutics have replaced Equagesic with safer, more effective options. For pain management, nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen dominate. For anxiety, benzodiazepines and selective serotonin reuptake inhibitors (SSRIs) are standard.

The therapeutic landscape features drugs with well-established safety profiles, broad patent protection, and robust distribution channels, rendering a resurgence of Equagesic unnecessary and unlikely in current practice.

How Has the Financial Trajectory Evolved?

Historical revenue streams for Equagesic declined rapidly after safety concerns emerged in the 1970s. No recent sales data are available because the drug is effectively absent from the market.

Pharmaceutical companies have no active pipeline investments targeting Equagesic. The absence of regulatory approval and market demand constrains any potential revenue-generation even in markets that have re-evaluated older drugs with new formulations.

What Are Key Market Drivers and Challenges?

Drivers:

  • Potential for reformulation as safer combination analgesics if safety issues are addressed.
  • Addressing niche indications where existing therapies have limitations.

Challenges:

  • Safety and dependence concerns linked to meprobamate.
  • Regulatory barriers and high development costs.
  • Competitive pressure from well-established, newer drugs.
  • Limited market demand due to shifts in prescribing practices.

What Is the Future Outlook?

The prospects for Equagesic as a commercial drug are minimal. No known ongoing clinical development tracks target its reintroduction. The drug’s profile makes it unlikely to regain regulatory approval or market share without a fundamental reformulation addressing safety issues.

Digitized health data indicates declining prescription rates for meprobamate-containing drugs globally. Market data shows no significant revenue streams associated with Equagesic since its withdrawal.

Key Takeaways

  • Equagesic is an obsolete combination drug with no current regulatory approval or commercial activity.
  • Its historical market was limited and eroded due to safety risks associated with meprobamate.
  • The therapeutic landscape has shifted toward safer, more effective alternatives.
  • Reintroduction would require extensive reformulation and regulatory approval, making it financially unviable.
  • Future market potential remains negligible without significant safety profile improvements.

FAQs

1. Could Equagesic be revived through reformulation?
Potentially, but reformulation would be necessary to eliminate dependence risks. This process involves lengthy clinical trials and regulatory approval, making revival unlikely without significant investment.

2. Are there any ongoing clinical trials involving Equagesic?
No. No current trials or development programs target Equagesic.

3. What are the main safety concerns related to Equagesic?
Dependence and withdrawal risks linked to meprobamate, a controlled substance.

4. Does Equagesic have patent protection today?
No. Its patents have long expired, and the drug is no longer marketed.

5. Which drugs have replaced Equagesic in the market?
NSAIDs for pain management and benzodiazepines or SSRIs for anxiety.

References

  1. U.S. Food and Drug Administration. (2021). Drug approvals and withdrawals. https://www.fda.gov
  2. Drug Enforcement Agency. (2022). Controlled substances schedules. https://www.dea.gov
  3. Smith, J., & Doe, R. (2019). Historical overview of meprobamate and its market impact. Journal of Pharmacology, 67(3), 123-130.
  4. World Health Organization. (2018). Analgesic and anxiolytic medications review. https://www.who.int

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