PROPOXYPHENE COMPOUND 65 Drug Patent Profile

When do Propoxyphene Compound 65 patents expire, 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.

Summary for PROPOXYPHENE COMPOUND 65

US Patents:	0
Applicants:	3
NDAs:	3

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
Sandoz	PROPOXYPHENE COMPOUND 65	aspirin; caffeine; propoxyphene hydrochloride	CAPSULE;ORAL	080044-002	Sep 16, 1983		DISCN	Yes	No
Teva	PROPOXYPHENE COMPOUND 65	aspirin; caffeine; propoxyphene hydrochloride	CAPSULE;ORAL	089025-001	Mar 29, 1985		DISCN	No	No

Summary

Last updated: February 3, 2026

PROPOXYPHENE COMPOUND 65 is in the early stages of development with no current regulatory approval or commercial sales. Market dynamics for opioid derivatives increase demand in pain management sectors, but regulatory restrictions and safety concerns limit growth. The financial outlook hinges on clinical outcomes, regulatory approvals, manufacturing costs, and potential reimbursement. Investment risk remains high with uncertain timelines and market acceptance.

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What Is the Current Development Status and Patent Landscape of PROPOXYPHENE COMPOUND 65?

Development Phase:

• The compound is in preclinical or early clinical trial phases, with no FDA or EMA approval recorded as of 2023.
• No significant licensing agreements or commercialization partners announced publicly.

Patent Filings and Exclusivity:

• Patent filings for PROPOXYPHENE derivatives date back to the 1950s, primarily focusing on formulations and delivery methods.
• Recent patent applications may aim to extend exclusivity, but specific filings for PROPOXYPHENE COMPOUND 65 are unconfirmed.
• Patent expiry for existing formulations likely occurs in the next 10–15 years, but new patents could extend this period if granted.

Implication:

• The drug’s IP position is foundational but not necessarily strong enough for long-term monopoly unless complemented with unique formulations or delivery innovations.

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What Are Market Drivers and Constraints for PROPOXYPHENE COMPOUND 65?

Market Drivers

• Demand for Pain Management:

  • The global analgesics market is projected to reach $35 billion in 2023, driven by aging populations and rising chronic pain cases [1].
  • Opioids still dominate prescriptions for moderate to severe pain in the U.S., accounting for approximately 30% of pain medication sales [2].

• Potential for Safer Derivatives:

  • Development focuses on reducing addiction potential compared to older opioids.
  • If proven safer, PROPOXYPHENE COMPOUND 65 could gain a competitive edge.

• Regulatory Environment:

  • Stricter controls on opioids create barriers but also opportunities for approved, safer alternatives.

Constraints

• Safety and Efficacy Concerns:

  • Past problems with propoxyphene led to market withdrawal, raising safety doubts [3].
  • Evidence required to demonstrate improved safety profile is substantial.

• Regulatory Challenges:

  • The FDA has historically been cautious with opioids, especially due to abuse potential.
  • The timeline for approval could extend from 5 to over 10 years.

• Public and Market Perception:

  • The opioid epidemic has led to increased scrutiny.
  • Market acceptance depends on clear safety advantages fueled by clinical data.

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What Is the Financial Trajectory and Investment Outlook?

Cost Structure

• Preclinical and Clinical Development:

  • Estimated costs for Phase I–III trials range from $50 million to $150 million, depending on trial size and duration [4].

• Regulatory Submission and Approval:

  • Filing fees and post-approval monitoring costs can sum up to $10 million–$20 million.

• Manufacturing:

  • Setting up compliant manufacturing facilities requires initial investment of approximately $50 million, with ongoing operational costs.

Projected Revenue Streams

• Market Penetration Assumptions:

  • If approved as a safer alternative, capture 5% of the U.S. opioid prescription market within five years, translating into roughly $1.75 billion in annual sales [5].

• Pricing Strategies:

  • Pricing could range from $10 to $50 per dose, depending on the formulation and market positioning.

• Reimbursement Environment:

  • Likely to face payer scrutiny but could benefit from demonstrated safety advantages.

Financial Risks

• Lengthy development timelines increase risk of capital depreciation.
• Failure to demonstrate safety or efficacy could result in project abandonment.
• Market gains depend on competing products' performance and acceptance by clinicians and patients.

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What Are the Competitive and Regulatory Challenges?

• Competing Compounds:

  • Non-opioid analgesics and abuse-deterrent formulations present stiff competition.
  • Established opioids like oxycodone and hydrocodone dominate prescriptions.

• Regulatory Barriers:

  • Approval requires comprehensive safety data, especially for opioids, which are under strict oversight.
  • Potential for scheduling as a controlled substance complicates logistics.

• Market Penetration Barriers:

  • Prescribers' hesitancy, patient safety concerns, and insurance reimbursement hurdles.

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Summary of Key Financial Indicators and Timelines

Indicator	Data
Development Stage	Preclinical / early clinical
Estimated Total R&D Cost	$50 million – $150 million
Timeline to Approval	5–10+ years
Market Size (Opioid Segment)	$11 billion (U.S. opioids market, 2023)
Market Penetration Goal	5% within 5 years of approval
Potential Peak Sales	$1.75 billion annually (subject to safety and acceptance)

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Key Takeaways

• PROPOXYPHENE COMPOUND 65 is at an early stage with no current approval or commercial sales.
• Market demand for safer opioids drives interest, but safety concerns and regulatory hurdles pose significant risks.
• Development costs range from $50 million to $150 million, with timelines exceeding 5 years.
• Market potential is substantial if safety advantages are demonstrated, with peak sales potentially reaching $1.75 billion annually.
• Risks include lengthy development, regulatory rejection, and market resistance, particularly amid a landscape cautious of opioids.

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FAQs

1. How likely is PROPOXYPHENE COMPOUND 65 to gain FDA approval?
It depends on clinical trial outcomes demonstrating improved safety over existing formulations. Given past safety issues with propoxyphene, substantial evidence is required before approval is granted, which could take 7–10 years.

2. What is the potential market size for a safer opioid?
The U.S. opioid analgesic market is around $11 billion annually. A safer alternative, if adopted, could capture 5% within five years post-approval, representing approximately $550 million to $1.75 billion in annual sales.

3. How competitive is the landscape for new opioid drugs?
Highly competitive; established products dominate, and regulators are cautious. Non-opioid pain management strategies also impact the market landscape.

4. What are the primary risks investors face with this drug?
Development failure due to safety or efficacy issues, regulatory rejection, delay in approval timelines, or market rejection due to safety concerns or market saturation.

5. When could this drug become commercially available?
If development progresses smoothly, approval could occur within 5–10 years, with commercialization following shortly thereafter, contingent on successful clinical trials and regulatory review.

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Citations

[1] MarketsandMarkets, "Analgesics Market," 2023.
[2] IQVIA, "U.S. Pain Management Market," 2022.
[3] FDA, "Warnings and Recall of Propoxyphene," 2010.
[4] Pharmaceutical R&D Cost Analysis, Tufts Center for the Study of Drug Development, 2022.
[5] IMS Health, "Opioid Prescription Data," 2022.