Last Updated: June 9, 2026

ATROPINE AND DEMEROL Drug Patent Profile


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When do Atropine And Demerol patents expire, and when can generic versions of Atropine And Demerol launch?

Atropine And Demerol is a drug marketed by Abbvie and is included in three NDAs.

The generic ingredient in ATROPINE AND DEMEROL is atropine sulfate; meperidine hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the atropine sulfate; meperidine hydrochloride profile page.

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  • What is the 5 year forecast for ATROPINE AND DEMEROL?
  • What are the global sales for ATROPINE AND DEMEROL?
  • What is Average Wholesale Price for ATROPINE AND DEMEROL?
Summary for ATROPINE AND DEMEROL
US Patents:0
Applicants:1
NDAs:3
DailyMed Link:ATROPINE AND DEMEROL at DailyMed

US Patents and Regulatory Information for ATROPINE AND DEMEROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie ATROPINE AND DEMEROL atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 087853-001 Nov 26, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie ATROPINE AND DEMEROL atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 087847-001 Nov 26, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie ATROPINE AND DEMEROL atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 087848-001 Nov 26, 1982 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
Last updated: February 6, 2026

What Are the Market Dynamics for Atropine and Demerol?

Atropine:
Already operates within a mature market primarily in hospitals and emergency settings. Its use in cardiac arrest, bradycardia, and as an antidote for certain poisonings sustains steady demand. Market growth is limited by the availability of alternative treatments and generics. Key regions include North America, Europe, and parts of Asia where regulated distribution ensures consistent use.

Demerol (Meperidine):
Experiencing decline due to safety concerns and regulatory restrictions. Originally widely used for severe pain management, Demerol's market shrank following warnings about neurotoxicity and the availability of safer opioids. Many countries have restricted or phased out Demerol, reducing its demand predominantly to specific legacy markets or regions with less regulatory enforcement.

Market Drivers:

  • Atropine benefits from ongoing use in emergency medicine, despite generic competition.
  • Demerol's decline is driven by safety concerns and the shift toward multimodal pain management strategies.
  • Growing opioid restrictions across many jurisdictions limit Demerol's market expansion.
  • Emerging markets show limited growth due to infrastructure constraints and slow regulatory adaptation.

Market Challenges:

  • Patent expirations have turned both drugs into generic products, pressuring prices.
  • Regulatory restrictions lead to decreased prescribing of Demerol, with some regions banning it entirely.
  • Competition from newer drugs with better safety profiles impacts Atropine's market share.
  • Manufacturing complexities and supply chain disruptions influence availability, especially for older medications.

How Do the Financial Trajectories of Atropine and Demerol Compare?

Atropine:
Given its manufacturing as a generic, revenue generation remains stable but modest. The market is flat or slightly declining, with annual sales estimates around $200 million globally. Patent expiration has not significantly affected at atropine’s core uses, which are supplied by multiple manufacturers. The product's pricing remains competitive, with minor variations based on regional policies.

Demerol:
Once a blockbuster, Demerol’s sales have diminished over the past decade. Annual worldwide sales are now estimated below $10 million, down from peak sales exceeding $150 million before the 2000s. The decline correlates with increased safety warnings and regulatory bans. A few suppliers still market Demerol in select countries, but the revenues are minimal.

Financial Outlook:

  • Atropine: Sustained demand in emergency medicine supports steady revenue. Growth potential is limited unless new indications emerge or formulations are improved.
  • Demerol: Market exit is probable in many jurisdictions due to safety concerns. Remaining sales are likely to diminish further unless regulatory restrictions are eased.

Pricing Trends:

  • Atropine prices have remained relatively stable due to generic competition, with slight regional variation.
  • Demerol prices have declined and are now largely marginal; some markets offer it at minimal margins due to regulatory bans.

Regulatory and Policy Impact on Market and Financials

Atropine:
Regulations govern manufacturing standards, distribution, and clinical use. No significant reform or restriction has impacted its market substantially over the last decade. Its status as an essential medicine in emergency care ensures continued compliance and usage. Changes in clinical guidelines moderately influence demand.

Demerol:
Regulatory agencies like the U.S. FDA and EMA have issued warnings and imposed restrictions on Demerol. Multiple countries have banned or restricted opioids like Demerol due to safety risks, significantly reducing its market. Ongoing regulatory pressures and safety concerns threaten future availability and revenues.


What Are the Key Trends and Future Prospects?

  • Atropine: Remains a standard emergency medication with minimal growth, primarily influenced by healthcare system funding, hospital practices, and potential new indications. No significant patent protections or innovations currently in development.

  • Demerol: Faces nearly complete obsolescence in major markets. Future sales will depend on regulatory decisions and availability in under-regulated markets. Limited innovation or pipeline activity exists given safety issues and market decline.

Pipeline and Innovation:
Neither drug currently has active development pipelines. For Atropine, minor efforts focus on alternative formulations or delivery systems. Demerol’s potential for repositioning is unlikely due to safety concerns and market erosion.


Key Takeaways

  • Market size and growth: Atropine has a stable, mature market; Demerol is in sharp decline.
  • Revenue trends: Atropine generates estimated global sales of around $200 million annually; Demerol's sales are below $10 million, mostly from legacy markets.
  • Regulatory environment: Atropine faces standard regulation; Demerol is increasingly restricted or banned worldwide.
  • Future outlook: Atropine's demand persists mainly in emergencies; Demerol's market is nearly extinct.

FAQs

1. Will Demerol regain market presence?
Unlikely. Regulatory bans and safety concerns dominate its decline, with little regulatory or clinical interest in revival.

2. Are there new formulations of Atropine under development?
Currently, no significant pipeline exists. Some efforts focus on alternative delivery methods but do not alter the core market dynamics.

3. How does the competition from other drugs affect Atropine?
Other anticholinergic agents and newer therapies compete in certain indications, but Atropine remains a first-line emergency treatment due to its established efficacy.

4. What regions are most affected by Demerol restrictions?
North America, Europe, and many developed countries have phased out Demerol. It persists in some under-regulated markets.

5. Can Demerol be repurposed for other indications?
There are no current efforts to reposition Demerol due to its safety profile. The risk-benefit profile inhibits such strategies.


References

[1] Market data provided by IQVIA and GlobalData, 2022.
[2] Regulatory summaries from the U.S. FDA and EMA on opioid bans, 2021.
[3] Johnson, et al. "Pharmacovigilance of Opioids," Journal of Pain Management, 2020.

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