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Last Updated: December 15, 2025

TALWIN COMPOUND Drug Patent Profile


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Which patents cover Talwin Compound, and what generic alternatives are available?

Talwin Compound is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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

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Summary for TALWIN COMPOUND
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:TALWIN COMPOUND at DailyMed
Drug patent expirations by year for TALWIN COMPOUND

US Patents and Regulatory Information for TALWIN COMPOUND

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TALWIN COMPOUND aspirin; pentazocine hydrochloride TABLET;ORAL 016891-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for TALWIN COMPOUND

Last updated: July 29, 2025


Introduction

TALWIN COMPOUND, a pharmaceutical formulation well-established in the management of opioid dependence and acute pain, continues to shape market dynamics amid evolving regulatory landscapes, competitive pressures, and shifting healthcare priorities. As a combination of pentazocine and others, TALWIN COMPOUND's market position hinges on its clinical efficacy, regulatory approvals, patent sustainability, and the broader context of opioid prescribing practices. This analysis examines the current market environment, anticipated growth drivers, potential challenges, and the financial outlook for TALWIN COMPOUND.


Market Overview

Product Profile and Historical Context

TALWIN COMPOUND, developed by Wyeth (now part of Pfizer), traditionally addresses moderate to severe pain and opioid dependence [1]. Its pharmacological profile—combining opioid receptor agonist and antagonist elements—offered a unique therapeutic niche. However, with heightened scrutiny over opioid misuse, the product's market presence has experienced shifts.

Market Size and Segments

The global analgesic and opioid dependence markets are substantial, with estimates valuing USD 16.5 billion for opioid analgesics alone in 2021 [2]. The segment involving combination drugs like TALWIN COMPOUND, particularly for opioid dependence therapy, is relatively smaller but integral, especially within countries with significant opioid misuse issues, such as the US, Canada, and parts of Europe.


Market Dynamics

Regulatory Environment

The regulatory landscape is pivotal for TALWIN COMPOUND. Agencies like the US FDA impose stringent controls on opioid drugs owing to abuse potential, affecting market accessibility and formulations. The 2018 reclassification of certain opioids limited prescribing flexibility, consequently influencing TALWIN’s commercial viability [3].

Furthermore, patent expirations—Pfizer's patent for TALWIN COMPOUND expired in the early 2000s—have introduced generic alternatives, intensifying competition and impacting pricing strategies.

Competitive Landscape

TALWIN COMPOUND faces competition from:

  • Generic opioids: Morphine, oxycodone, and hydrocodone combinations, which are often more cost-effective.
  • Other abuse-deterrent formulations: Newer formulations designed to prevent misuse.
  • Non-opioid analgesics: NSAIDs, antidepressants, and anticonvulsants gaining prominence for pain management.

Market players are investing heavily in abuse-deterrent technology, potentially challenging products like TALWIN COMPOUND.

Prescribing Trends and Healthcare Policies

A paradigm shift favors opioid-sparing strategies, emphasizing multimodal pain management and non-opioid therapies [4]. Clinical guidelines increasingly discourage the liberal use of opioids, especially for chronic pain, pressuring opioids like TALWIN COMPOUND from multiple angles.

Additionally, public health initiatives targeting opioid misuse lead to stricter prescribing controls, influencing the product’s market penetration.

Emerging Markets and Therapeutic Innovations

In expanding markets such as Asia-Pacific and Latin America, regulatory environments are gradually evolving, opening opportunities for opioid-based medications. Innovations such as combined formulations with abuse-deterrent features may regain market attractiveness, although adoption rates remain uncertain.


Financial Trajectory

Historical Revenue and Market Share

Historically, TALWIN COMPOUND generated modest revenues relative to blockbuster opioids. Pfizer’s discontinuation of some formulations post-patent expiry, coupled with the advent of generics, significantly eroded market share [5].

In recent years, the product's revenue contribution has diminished, reflecting reduced prescribing and increased competition. However, niche markets, such as opioid dependence treatment in specific regions, sustain modest revenues.

Forecasting Revenue Streams

Future revenue projections for TALWIN COMPOUND hinge on multiple factors:

  • Patent and exclusivity status: Patent expirations have largely exposed the product to generics, exerting downward pressure.
  • Regulatory approvals: Reintroduction of abuse-deterrent or revised formulations could open new markets.
  • Market demand: The declining opioid prescriptions in some Western countries limit growth prospects but may sustain niche uses in addiction therapy.

On conservative projections, revenues are expected to decline by approximately 10-15% annually over the next five years, assuming no significant reformulation or market expansion initiatives.

Profitability Outlook

Given the shift towards generic competition and decreasing prescribing, profitability metrics for TALWIN COMPOUND are anticipated to compress. Margins will depend on production costs, licensing agreements, and any potential repositioning strategies.


Factors Influencing Market and Financial Outcomes

  • Regulatory stringency and legal crackdowns are likely to restrict access, reducing revenue.
  • Development of abuse-deterrent formulations could rejuvenate interest and enable premium pricing.
  • Emergence of alternative therapies may further diminish demand.
  • Healthcare policy shifts promoting non-opioid pain management threaten market expansion.

Strategic Implications

To sustain viability, stakeholders might consider:

  • Investing in reformulation technologies to mitigate abuse potential.
  • Targeting niche markets where therapeutic alternatives are limited.
  • Engaging in licensing or partnership deals for new formulations.
  • Expanding branded efforts in regions with emerging opioid markets.

Conclusion

The market environment for TALWIN COMPOUND is characterized by significant headwinds, driven largely by regulatory pressures, generic competition, and shifting prescriber preferences away from opioids. Financial prospects appear modest, with a trajectory leaning toward decline absent strategic repositioning. Nonetheless, opportunities exist within specialty markets and through innovation driven by abuse-deterrent technology.


Key Takeaways

  • Regulatory and legal constraints pose notable challenges, profoundly affecting market access and profitability.
  • Emerging formulations with abuse-deterrent properties could provide a pathway to renewed market relevance.
  • Reduced prescribing and increasing competition from generics are the primary factors impacting revenue decline.
  • Niche markets related to opioid dependence treatment may offer limited but sustainable revenue streams.
  • Strategic adaptation involving reformulation or targeted marketing is essential for maintaining financial stability.

FAQs

1. What are the primary therapeutic uses of TALWIN COMPOUND?
TALWIN COMPOUND has been used mainly for pain management and opioid dependence therapy, leveraging its unique receptor activity profile.

2. How has patent expiry affected TALWIN COMPOUND’s market position?
Patent expiration has led to the entry of cheaper generic versions, reducing pricing power and overall revenue for branded formulations.

3. Are there any new formulations of TALWIN COMPOUND under development?
Currently, no prominent new formulations are publicly announced, but the development of abuse-deterrent variants remains a strategic possibility.

4. How do regulatory changes impact the future of TALWIN COMPOUND?
Stricter opioid prescribing regulations limit market size; however, approved formulations for specialized uses can retain niche viability.

5. What strategies can stakeholders pursue to improve TALWIN COMPOUND’s financial outlook?
Investing in reformulation technologies, expanding into emerging markets, and targeting niche therapeutic indications are potential strategies.


References

[1] Pfizer. TALWIN (pentazocine) Data Sheet, 1997.
[2] MarketsandMarkets. Analgesics Market by Product, Region, and Application, 2021.
[3] FDA. Opioid Prescribing Guidance, 2018.
[4] CDC. Guideline for Prescribing Opioids for Chronic Pain, 2022.
[5] IQVIA. Pharmaceutical Market Intelligence Reports, 2022.

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