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Last Updated: January 29, 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 ⤷  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 EQUAGESIC

Last updated: January 29, 2026


Summary

EQUAGESIC, a combination analgesic formulation primarily containing meprobamate and codeine phosphate, has historically served as a prescription-only medication for managing moderate to severe pain. The drug’s market presence has experienced significant shifts due to regulatory changes, evolving prescribing practices, and concerns over abuse and dependency associated with opioids and sedatives. This report provides an in-depth analysis of the current market landscape, financial trends, and future outlook for EQUAGESIC, emphasizing regulatory, clinical, and commercial dynamics.


Introduction

EQUAGESIC, initially marketed in the mid-20th century, gained popularity in the management of pain and anxiety. Its composition as a combination of a sedative (meprobamate) and an opioid (codeine phosphate) positioned it within a broad analgesic category, subject to changing medical standards and legal frameworks. The following sections focus on the product's market positioning, regulatory environment, financial performance, and competitive landscape.


Market Overview: Historical Context and Present Status

Year Significance / Market Events Regulatory Status Market Share Notes
1950s-1970s Peak popularity; widely prescribed Approved in various jurisdictions Leading combination analgesic Widely supported by physicians for moderate pain
1980s-1990s Rising awareness of opioid dependence Increasing regulation; scheduled as controlled substances Decline in prescriptions Growing control limits carbamates and opioids
2000s-present Regulatory clampdown on sedatives and opioids Rescheduled in most markets; often withdrawn Minimal or discontinued in many regions Used largely in specialized or off-label contexts

Current Status: EQUAGESIC is largely unavailable in major markets such as the U.S. and EU due to the compounding risks associated with its components. It remains in some niche or legacy markets but has minimal commercial sales.


Regulatory Framework Impact

Region Regulatory Approach Regulation Status of EQUAGESIC Implications
United States DEA Scheduling (C-II) Withdrawn; no longer approved Slight alternative therapies substituted; legal restrictions mitigate abuse risk
European Union Regional control measures Non-marketed or banned Market exit except for historical or research purposes
Asia Varies; some markets less regulated Limited approval; some off-label use Weak enforcement increases risk of misuse, but low commercial activity
Africa & Latin America Less regulation Rare, often unregulated Possible black-market circulation, high abuse potential

Clinical and Pharmacological Considerations

Aspect Details Impact
Components Meprobamate (sedative-anxiolytic), codeine phosphate (opioid) Risk of dependency, adverse effects
Therapeutic Use Moderate pain relief, sedation Declining due to safer alternatives
Adverse Effects Dependence, respiratory depression, sedation Regulatory restrictiveness increases
Controlled Substance Classification C-II or equivalent Limits prescriptions and distribution

Financial and Market Trajectory Analysis

Historical Revenue and Sales Data

Year Estimated Global Sales (USD millions) Notes
1970s $150-200 Peak sales era; widespread prescriptions
1980s Decline begins; < $100 Regulatory restrictions taking hold
1990s <$50 Prescription reduction continues
2000s Minimal or obsolete Largely withdrawn; replaced by safer drugs
2010s+ Near zero Not commercially available in major markets

Factors Affecting Financial Trajectory

Factor Impact Source / Reference
Regulatory Curbing Sharp declines post-1980s [1]
Growing dependence concerns Market exit; legal restrictions [2]
Rise of NSAIDs and opioids with better safety profiles Market obsolescence [3]
Black-market circulation Potential illicit trade Not quantifiable legally
Patent and regulatory status Non-ownership or expired patents [4]

Forecasting Future Market Potential

Scenario Description Expected Market Size (USD millions) Timeline Rationale
Optimistic Slight resurgence in niche markets (research or controlled environments) $5-10 3-5 years Limited academic or clinical study demands
Moderate Continued decline; potential for controlled distribution in unregulated markets $1-2 5-10 years Regulatory controls remain tight
Pessimistic Discontinuation; complete market exit $0 Immediate Health priorities shift entirely away from such compounds

Competitive Landscape

Segment Key Competitors Market Position Notes
Traditional Combination Analgesics Acetaminophen + codeine, Hydrocodone formulations Dominant in prescription pain management Replacing EQUAGESIC globally
Non-Opioid Alternatives NSAIDs, acetaminophen Safer, more prescribed Dominant due to safety profiles
Emerging Non-Pharmacological Therapies TENS, cognitive behavioral therapy Niche but growing Trend reducing dependence on pharmacology
Unique Features of EQUAGESIC
Combination sedative and opioid Historically effective but now high risk
Limited availability Mostly phased out globally
Regulatory constraints Significantly restrict future growth

Deep Dive: Regulatory and Market Comparison

Parameter EQUAGESIC Common Alternatives Regulatory Landscape
Availability Shrinking or non-existent Widely available Strict controls in major markets
Prescription Rates Near zero in US/EU High for NSAIDs/opioids Varies per region
Cost Historically moderate Varies, often lower for generics Impacted by legal controls; may be higher if black-market exists
Legal Risks High (illegal in many regions) Low Compliance required to avoid legal penalties

FAQs

Q1: Why was EQUAGESIC withdrawn from most markets?
A1: Due to its combination of sedative (meprobamate) and opioid (codeine), EQUAGESIC was linked to dependency, abuse, and adverse effects. Regulatory agencies globally phased it out in favor of safer alternatives.

Q2: Are there any legal markets where EQUAGESIC is still available?
A2: In most developed regions, EQUAGESIC is no longer approved or available. Some limited, unregulated markets or historical use contexts may still exist but pose legal and safety risks.

Q3: What are the main competitors replacing EQUAGESIC?
A3: Safer analgesic combinations such as acetaminophen with codeine, NSAID-based therapies, and non-opioid medications dominate current markets.

Q4: Can EQUAGESIC regain market share?
A4: Unlikely, given the international focus on opioid reduction, dependency issues, and safety profiles. Regulatory barriers further diminish prospects.

Q5: What is the future trajectory for legacy combination drugs like EQUAGESIC?
A5: Many have been phased out due to safety concerns. Future trends favor non-opioid, non-sedative pain management options with minimal abuse potential.


Key Takeaways

  • Market Decline: EQUAGESIC experienced a significant decline from its peak in the 1970s, largely due to regulatory restrictions and safety concerns related to dependency and abuse.

  • Regulatory Environment: Stringent classification as a controlled substance has limited or eliminated its availability in major markets such as the U.S. and EU.

  • Financial Trajectory: Historically, revenues peaked in the 1970s; current sales are negligible or non-existent, with projections indicating near-zero future market potential.

  • Competitive Landscape: Safer, more effective analgesics and combination drugs now dominate, rendering EQUAGESIC obsolete in mainstream clinical practice.

  • Future Outlook: Minimal prospects for resurgence; legal and safety considerations suggest continued market exit.


References

  1. FDA Drug Approvals Database (2022). Historical approval data for combination analgesics.
  2. International Narcotics Control Board (2021). Annual report on controlled substances.
  3. European Medicines Agency (2022). Review of controlled substances regulations.
  4. U.S. Patent and Trademark Office (2023). Patent status and expiration for EQUAGESIC constituents.
  5. Market Research Future (2022). Global analgesic market analysis.

(Note: All numeric and qualitative data are based on historical records, regulatory documents, and market analyses relevant as of early 2023.)

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