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Last Updated: March 27, 2026

PROPOXYPHENE COMPOUND 65 Drug Patent Profile


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Which patents cover Propoxyphene Compound 65, and when can generic versions of Propoxyphene Compound 65 launch?

Propoxyphene Compound 65 is a drug marketed by Ivax Sub Teva Pharms, Sandoz, and Teva. and is included in three NDAs.

The generic ingredient in PROPOXYPHENE COMPOUND 65 is aspirin; caffeine; propoxyphene hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; caffeine; propoxyphene hydrochloride profile page.

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Summary for PROPOXYPHENE COMPOUND 65
Drug patent expirations by year for PROPOXYPHENE COMPOUND 65

US Patents and Regulatory Information for PROPOXYPHENE COMPOUND 65

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms PROPOXYPHENE COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 083077-002 Dec 7, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz PROPOXYPHENE COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 080044-002 Sep 16, 1983 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva PROPOXYPHENE COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 089025-001 Mar 29, 1985 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

PROPOXYPHENE COMPOUND 65 Market Analysis and Financial Projection

Last updated: February 16, 2026

How is the market for Propoxyphene Compound 65 evolving?

The market for Propoxyphene Compound 65 exhibits limited growth prospects due to regulatory restrictions and declining usage. The drug, once common as an analgesic, is largely phased out worldwide. It is no longer available in the United States, having been withdrawn in 2010 after the FDA linked it to overdose risks, including fatalities from cardiac arrhythmias.

What are the key regulatory and legal factors influencing Propoxyphene Compound 65?

The U.S. Food and Drug Administration (FDA) banned Propoxyphene in 2010. The drug's withdrawal stems from safety concerns over its narrow therapeutic margin and potential for overdose. Similar bans or restrictions occurred in other markets, reducing global demand. Legal actions, including lawsuits over overdose deaths, further dissuade manufacturers from producing or marketing Propoxyphene.

What is the current commercial landscape for Propoxyphene Compound 65?

No major pharmaceutical companies actively produce Propoxyphene Compound 65. Patent protections are obsolete or non-existent due to the drug’s discontinued status. Small manufacturers may produce generic versions, but sales volumes have fallen sharply. Market data indicates a near-zero level of legitimate sales since 2010, with some underground or unregulated distribution possibly persisting.

How do pricing and sales figures look for Propoxyphene Compound 65?

Official sales data since 2010 reflect a collapse to negligible levels. The drug’s price, historically around $1 to $2 per tablet, has no significant market presence today. Any remaining sales might occur in illicit channels, but these are not captured accurately and are minimal.

Are there any emerging markets or niche uses for Propoxyphene Compound 65?

No credible evidence supports ongoing legitimate use. Research into alternative analgesics has replaced Propoxyphene in clinical practice. Trials or studies proposing new applications have not been publicly documented or approved by regulatory bodies. The trend suggests extinction from both legal and medical perspectives.

What is the outlook for future financial performance related to Propoxyphene Compound 65?

The future financial trajectory for Propoxyphene Compound 65 is essentially flat to declining, approaching zero. Regulatory prohibitions, legal liabilities, and clinical obsolescence eliminate the possibility of recovery or expansion. Any residual revenue derives from illicit markets, which are unpredictable and not sustainable in a regulated industry context.

How do patient safety concerns and regulatory actions influence market dynamics?

Safety concerns have been decisive. The FDA’s 2010 ban eliminated legal sales in the U.S., the largest pharmaceutical market. Similar measures in other countries have followed. These actions eliminate demand from licensed suppliers, further reducing any potential market activity. Increased legal and health agency vigilance deters illegal sales.

What strategic considerations should companies have regarding Propoxyphene Compound 65?

Companies should avoid investing in production or marketing of Propoxyphene due to regulatory prohibitions and reputational risks. Focus should shift toward developing safer analgesics with proven safety profiles and regulatory approval, aligning with current market and safety standards.

What are the implications for investors or R&D initiatives involving Propoxyphene?

Investors should regard Propoxyphene as an obsolete asset. R&D efforts directed toward this compound lack commercial viability. Resources are better allocated to newer, safer analgesics with active development pipelines and clear regulatory pathways.

Key Takeaways

  • Propoxyphene Compound 65 has no active market in the U.S. since its ban in 2010 and a similar global withdrawal pattern.
  • Regulatory restrictions and safety issues have rendered the drug obsolete, eliminating legal sales.
  • Small, unregulated markets may still exist but have minimal or no verified sales and carry legal risks.
  • Future prospects remain bleak due to safety concerns, legal liabilities, and a shift toward safer alternatives.
  • Investment or R&D focus on this compound is not advisable; the market is effectively nonexistent.

FAQs

Q1: Can Propoxyphene Compound 65 be legally manufactured today?
A1: No. The FDA banned propoxyphene in 2010, and most other countries imposed similar restrictions. Manufacturing is legally restricted due to safety concerns.

Q2: Are any companies still producing Propoxyphene-based products?
A2: No major companies produce propoxyphene now. Any remaining production is negligible and generally not compliant with current regulations.

Q3: Is there any legitimate medical use for Propoxyphene today?
A3: No. It is no longer approved for medical use in most jurisdictions, including the U.S.

Q4: What is the potential for illicit markets for Propoxyphene?
A4: While illicit sales may occur, they are untracked, illegal, and pose health and legal risks. They are unlikely to contribute meaningfully to market dynamics.

Q5: What alternatives are replacing Propoxyphene in pain management?
A5: Safer opioids such as tramadol and hydrocodone, alongside non-opioid analgesics like NSAIDs, are replacing propoxyphene in medical practice.


Sources:

[1] FDA. "Final Rule: Suspension of the Approval of New Drug Applications and Abandonment of Pending Applications for Analgesic Drugs Containing Propoxyphene." 2010.

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