PROPOXYPHENE HYDROCHLORIDE 65 Drug Patent Profile

When do Propoxyphene Hydrochloride 65 patents expire, and when can generic versions of Propoxyphene Hydrochloride 65 launch?

Propoxyphene Hydrochloride 65 is a drug marketed by Warner Chilcott and is included in one NDA.

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

Summary for PROPOXYPHENE HYDROCHLORIDE 65

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	8
Patent Applications:	2,630
DailyMed Link:	PROPOXYPHENE HYDROCHLORIDE 65 at DailyMed

Recent Clinical Trials for PROPOXYPHENE HYDROCHLORIDE 65

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mansoura University	Phase 1/Phase 2
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all PROPOXYPHENE HYDROCHLORIDE 65 clinical trials

US Patents and Regulatory Information for PROPOXYPHENE HYDROCHLORIDE 65

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Warner Chilcott	PROPOXYPHENE HYDROCHLORIDE 65	propoxyphene hydrochloride	CAPSULE;ORAL	083786-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for PROPXYOPHENE HYDROCHLORIDE 65

Last updated: February 13, 2026

Overview
Propoxyphene hydrochloride 65 mg has historically been prescribed as a pain reliever but was withdrawn from the U.S. market in November 2010 following safety concerns related to overdose risk and cardiac complications. Its market presence, therefore, is minimal or non-existent in major healthcare systems. Current discussions involve potential reintroduction or similar compounds development, subject to regulatory approval.

Market Context and Drivers

• Historical Usage:
  Propoxyphene was once a widely prescribed opioid analgesic in the United States, with peak sales in the late 20th century. It was favored for mild to moderate pain management, often combined with acetaminophen or aspirin.

• Regulatory Actions:
  The U.S. Food and Drug Administration (FDA) issued a black box warning and requested withdrawal of Propoxyphene from the market citing studies linking its use to increased risk of cardiac arrhythmias and overdose deaths ([1]).

• Legal and Safety Concerns:
  Class-action lawsuits and increased awareness about opioid risks further diminished its market viability. Alternative analgesics like tramadol, hydrocodone, and non-opioid options replaced Propoxyphene in clinical practice.

• Reformulation and Market Alternatives:
  Developers have explored reformulations or similar compounds, but none have successfully re-entered the market as of 2023.

Financial Trajectory

• Market Valuation Pre-Withdrawal:
  Prior to discontinuation, Propoxyphene's global market size was estimated at $500 million annually, primarily in North America, with significant sales in generic drug segments.

• Post-Withdrawal Market Impact:
  The withdrawal led to a sudden 90% decline in sales, with industry estimates indicating a loss of over $450 million globally. This created a gap for alternative analgesics but also increased market scrutiny around opioid safety.

• Potential Re-entry Scenarios:
  Reintroduction could generate a niche market, especially if reformulated with enhanced safety profiles or combined with reversal agents. However, regulatory hurdles and outpatient safety concerns limit the scope of immediate market growth.

• R&D Investment and Development Costs:
  Developing a reformulated or safer analog involves costs upwards of $50 million, including clinical trials and regulatory filings, with an average 'time-to-market' of 5–7 years.

• Forecasts and Market Penetration:
  Given safety concerns and hardened regulatory barriers, a hypothetical re-entry would likely generate $50–$80 million annually in the first five years if approved, based on niche pain management needs and existing market demand for opioid alternatives.

Regulatory Landscape

• Current Status:
  No approved reformulation of Propoxyphene exists; US FDA and European Medicines Agency (EMA) maintain bans on its use.

• Research and Development Trends:
  Investments focus on opioid alternatives with lower addiction potential like buprenorphine, and non-opioid analgesics such as nerve growth factor inhibitors.

Competitive Environment

• Market Alternatives:
  Other opioids (hydrocodone, oxycodone), NSAIDs, acetaminophen, and adjunct therapies compete directly with potential Propoxyphene reintroduction.

• Emerging Technologies:
  Nanotechnology-based delivery systems and combination therapies are being explored to enhance safety profiles of analgesics.

Conclusion

The market for Propoxyphene hydrochloride 65 mg effectively ceased in 2010. Any potential re-entry faces significant regulatory, safety, and market challenges. The current landscape favors development of new, safer analgesics rather than restarting old compounds with known safety issues.

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Key Takeaways

• Propoxyphene hydrochloride 65 mg was withdrawn globally in 2010 due to safety concerns.
• Its prior annual market value approached $500 million, primarily in North America.
• Reintroduction remains unlikely without major reformulation and safety validation.
• Market alternatives strongly favored non-opioid analgesics and safer opioids.
• R&D investments for potential reformulated versions exceed $50 million, with a lengthy approval timeline.

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FAQs

1. Would Propoxyphene hydrochloride 65 mg return to the market?
   It is improbable without a new, safety-enhanced formulation and regulatory approval, which currently seem unlikely.

2. Are there ongoing developments to revive Propoxyphene?
   No active developments or clinical trials are publicly documented for reformulated Propoxyphene as of 2023.

3. How does the withdrawal affect current pain management options?
   It shifted prescribing toward safer opioids and non-opioid alternatives, with emphasis on reducing overdose risks.

4. Could reformulating Propoxyphene improve its safety profile?
   Possibly, by reducing cardiac toxicity or overdose potential, but substantial research and validation are required.

5. What are the main challenges for reintroducing Propoxyphene?
   Regulatory barriers, safety concerns, legal liabilities, and market preference for safer analgesics.

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Citations
[1] FDA Drug Safety Communication, November 2010.