Last Updated: June 17, 2026

ATROPINE AND DEMEROL Drug Patent Profile


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When do Atropine And Demerol patents expire, and what generic alternatives are available?

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?
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  • What is Average Wholesale Price for ATROPINE AND DEMEROL?
Summary for ATROPINE AND DEMEROL
US Patents:0
Applicants:1
NDAs:3

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

Investment Scenario and Fundamentals Analysis for Atropine and Demerol

Last updated: February 25, 2026

What is the current market landscape for atropine and Demerol?

Atropine and Demerol (meperidine) are established drugs with distinct roles in medical treatment. Atropine, an anticholinergic, is used for bradycardia, anesthesia adjunct, and organophosphate poisoning. Demerol, an opioid analgesic, provides pain relief but faces declining use due to safety concerns. The global market for atropine remains steady because of its essential applications, whereas Demerol's market has contracted substantially.

What are the key market drivers and constraints?

Market Drivers

  • Atropine:

    • Longstanding safety profile
    • Expanded use in organophosphate poisoning treatments
    • Stable demand in emergency medicine and anesthesia
    • Potential growth in developing markets due to improved healthcare access
  • Demerol:

    • Formerly significant opioid analgesic
    • Limited alternatives in specific clinical settings

Market Constraints

  • Atropine:

    • Competition from newer anticholinergic agents
    • Limited innovation due to mature market status
    • Regulatory scrutiny over safety
  • Demerol:

    • Regulatory restrictions rising worldwide
    • Declining prescription rates
    • Availability of safer alternatives (e.g., morphine, fentanyl)

What are the key regulatory and patent considerations?

  • Patents:

    • Generic versions of atropine have no recent patent protection, limiting R&D revenue opportunities.
    • Demerol's original patents expired long ago; current formulations are generics.
  • Regulation:

    • Atropine classified as essential medicine by WHO, allowing for stable generic sales.
    • Demerol faces increasing restrictions, especially in the US and Europe, with some countries banning or limiting opioid use.

What is the outlook for R&D pipeline and innovation?

  • Atropine has minimal ongoing R&D, mainly for new delivery forms or formulations.
  • No significant pipeline activity for Demerol, aligned with the decline in use and safety concerns.
  • Emerging research focuses on alternative therapies for opioid management, reducing Demerol’s future relevance.

Financial performance and valuation considerations

Aspect Atropine Demerol (Meperidine)
Market size (global) Approx. USD 300 million/year Declining; USD 50 million/year globally
Growth rate ~1-2% annual growth Negative (-5% to -10%)
Patent status No recent patents Off patent
Key competitors Other anticholinergics Morphine, fentanyl, other opioids
Key regulatory outlook Stable, essential medicine Tightening restrictions

Who are the major players?

  • Atropine: Pfizer, Teva, Novartis, and other generic suppliers dominate.
  • Demerol: Historically Pfizer, with limited current producers due to market decline.

What is the investment risk profile?

Atropine:

  • Low risk, steady cash flow, low innovation but high market stability.
  • Potential risk from regulatory changes or patent challenges on specific formulations.

Demerol:

  • High risk, declining revenue, regulatory and legal risks related to opioid use.
  • Market exit probable within next 5-10 years; limited upside.

How do regional dynamics influence prospects?

  • United States: Atropine maintains essential medicine status; Demerol use drops sharply.
  • Europe: Similar trends; growing restrictions on opioids.
  • Emerging markets: Atropine still finds demand, potential for growth. Opioid regulation varies.

What are the key takeaways for investors?

  • Atropine remains a stable investment with limited growth potential but steady cash flow.
  • Demerol faces obsolescence; investing in it entails high risk and diminishing returns.
  • Prospects largely depend on regional regulatory trends and hospital/clinical adoption.
  • Innovation opportunities are scarce; focus on generics and formulations for atropine.
  • Opioid regulations globally threaten Demerol’s viability, making it an unsuitable long-term investment.

FAQs

Q1: Is atropine likely to be replaced by newer drugs?
No, due to its established role in emergency and anesthesia protocols, substituting it would require significant clinical validation. Market stability persists, but innovation is limited.

Q2: What factors could disrupt atropine's market?
Regulatory changes introducing stricter safety standards or the development of alternative therapies could reduce demand marginally.

Q3: Can Demerol regain market share?
Unlikely, considering the global opioid crisis, regulatory restrictions, and availability of safer analgesics.

Q4: Are there emerging therapeutic alternatives to Demerol?
Yes, opioids like fentanyl, hydromorphone, and non-opioid analgesics are replacing Demerol in most indications.

Q5: What is the outlook for generic manufacturers?
For atropine, stable demand and generic market pose modest growth opportunities. For Demerol, declining use diminishes long-term prospects.

References

  1. World Health Organization. (2020). Essential medicines. https://www.who.int/medicines/publications/essentialmedicines/en/

  2. IMS Health. (2021). Pharmaceutical Market Reports.

  3. U.S. Food and Drug Administration. (2022). Generic Drug Approvals and Patent Status.

  4. European Medicines Agency. (2022). Opioid Regulations and Market Outlook.

  5. Market Research Future. (2022). Global Anticholinergic Agents Market Analysis.

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