STADOL PRESERVATIVE FREE Drug Patent Profile

Which patents cover Stadol Preservative Free, and when can generic versions of Stadol Preservative Free launch?

Stadol Preservative Free is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in STADOL PRESERVATIVE FREE is butorphanol tartrate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stadol Preservative Free

A generic version of STADOL PRESERVATIVE FREE was approved as butorphanol tartrate by HIKMA on August 12^th, 1998.

Summary for STADOL PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	715
DailyMed Link:	STADOL PRESERVATIVE FREE at DailyMed

US Patents and Regulatory Information for STADOL PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for STADOL PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982

International Patents for STADOL PRESERVATIVE FREE

See the table below for patents covering STADOL PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	14440	INTERMEDIATES IN THE PREPARATION OF 14-HYDROXY MORPHINAN DERIVATIVES
Malaysia	7900027	3-SUBSTITUTED-MORPHINAN DERIVATIVES
Ireland	36688	3-SUBSTITUTED-MORPHINAN DERIVATIVES

Market Dynamics and Financial Trajectory for STADOL PRESERVATIVE FREE

Last updated: July 28, 2025

Introduction

STADOL PRESERVATIVE FREE (generic name: butorphanol tartrate), a potent opioid analgesic formulated without preservatives, has carved out a niche in pain management amid evolving healthcare policies and patient safety concerns. Understanding its market dynamics involves analyzing current pharmaceutical trends, regulatory landscape, competitive positioning, and potential financial trajectories. This article provides an in-depth analysis to inform strategic decision-making for stakeholders involved in this niche analgesic segment.

Market Overview and Therapeutic Positioning

STADOL PRESERVATIVE FREE primarily addresses moderate to severe pain, especially in post-operative settings, labor, and cancer pain management. Its preservative-free formulation appeals to sensitive patient populations, including neonates and immunocompromised individuals, where preservatives pose risk of adverse reactions.

Globally, the opioid analgesics market is expanding due to increasing prevalence of chronic pain and surgical procedures. However, the market faces steep regulatory scrutiny owing to concerns over misuse and addiction. STADOL's preservative-free profile can serve as a differentiator by emphasizing safety and tolerability, aligning with the shift toward safer opioid formulations.

Regulatory and Reimbursement Dynamics

Recent regulatory trends increasingly favor preservative-free drugs, especially in pediatric and oncology settings, driven by safety concerns and better understanding of preservative-induced adverse events [1]. Agencies such as the FDA and EMA have expedited review pathways for formulations that demonstrate improved safety profiles.

Reimbursement policies favor drugs that demonstrate superior safety and patient compliance. Given the rising focus on opioid stewardship, payers may favor formulations with proven reduced adverse events, potentially positively affecting STADOL PREMIUM pricing strategies. Nonetheless, reimbursement approval hinges on clinical evidence demonstrating significant safety benefits over competitors.

Competitive Landscape

The opioid analgesics arena hosts entrenched players like morphine, fentanyl, and generic versions of butorphanol. However, preservative-free variants are still emerging, presenting a significant opportunity. Competitors may include other preservative-free opioids or alternative pain management drugs such as non-opioid analgesics, NSAIDs, or nerve blockers.

Key differentiators include:

• Formulation Safety: Reduced risk of preservative-related toxicity.
• Patient Populations: Enhanced suitability for vulnerable cohorts.
• Regulatory Acceptance: Faster approvals in safety-sensitive applications.

One challenge for STADOL PRESERVATIVE FREE lies in patent and exclusivity terms, potentially impacting pricing power and market share. Moreover, the ongoing opioid crisis remains a barrier, prompting stricter prescribing guidelines that could hinder market penetration.

Market Entry and Growth Strategies

To capitalize on growth opportunities, manufacturers should:

• Invest in Evidence Generation: Conduct clinical trials emphasizing safety and efficacy, especially in pediatric and oncology populations, to secure regulatory approvals and payer reimbursement.
• Strengthen Regulatory Engagement: Work proactively with agencies to align on safety documentation, potentially accelerating approval timelines.
• Expand Indications: Explore additional areas such as labor analgesia or palliative care.
• Develop Differentiated Marketing: Emphasize preservative-free safety benefits to clinicians and hospitals.
• Partnerships and Licensing: Collaborate with hospitals and healthcare institutions to incorporate STADOL PRESERVATIVE FREE into pain management protocols.

Financial Trajectory and Revenue Projections

The financial potential of STADOL PRESERVATIVE FREE depends on several factors:

Market Penetration and Pricing

A premium pricing model may be justified by the safety profile and clinical benefits. Assuming a conservative market penetration of 5% within the opioid analgesics segment in developed markets (e.g., US, EU), revenues could reach hundreds of millions annually within five years, contingent on successful regulatory approval, clinical adoption, and reimbursement.

Cost Structure

Research & development expenditures for new formulation approval, clinical trials, and post-market surveillance are substantial, but moderate for reformulation rather than new chemical entities. Manufacturing costs are anticipated to be comparable or slightly higher due to the specialized preservative-free process.

Profitability Outlook

Given the escalating public and clinical emphasis on safety, preservative-free opioids could command higher margins. The opportunity for early market entry and clinical differentiation enhances revenue potential. However, the risk of regulatory delays, market saturation with generics, and increasing opioid scrutiny could cap growth.

Long-Term Outlook

Over ten years, continuous innovation (e.g., combination therapies, extended-release variants) and expansion into emerging markets could bolster revenue streams. The increasing global burden of pain management needs further amplifies long-term demand, particularly in regions with aging populations and rising surgical procedures.

Risks and Challenges

• Regulatory Limitations: Stringent controls on opioids may restrict prescribing, limiting market size.
• Market Saturation: Entry barriers for generic manufacturers could reduce profitability.
• Legal and Public Sentiment: Ongoing opioid crisis adds complexity to market acceptance and reimbursement.
• Pricing Pressures: Payer negotiations might suppress margins, especially as generics proliferate.

Conclusion

STADOL PRESERVATIVE FREE holds considerable promise within the opioid pain management landscape, driven by safety, regulatory appreciation for preservative-free formulations, and demographic trends favoring targeted therapies. Its market trajectory hinges on proactive clinical validation, regulatory engagement, strategic partnerships, and aligning with shifting healthcare priorities towards safer opioids. The path to sustained profitability involves navigating regulatory complexities, market competition, and societal attitudes surrounding opioids.

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Key Takeaways

• The preservative-free profile offers a competitive edge in safety-critical patient populations, aligning with regulatory trends favoring safer formulations.
• Market growth depends on securing regulatory approvals, demonstrating clinical superiority, and integrating into evolving pain management protocols.
• Revenue potential is significant but constrained by opioid regulation, market saturation, and societal perceptions.
• Strategic investments in clinical evidence, stakeholder engagement, and expanding indications are essential for maximizing financial trajectory.
• Long-term success requires adaptability to market dynamics, ongoing innovation, and proactive risk management.

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FAQs

1. What distinguishes STADOL PRESERVATIVE FREE from other opioid analgesics?
   Its preservative-free formulation reduces the risk of preservative-related adverse reactions, making it safer for vulnerable populations such as neonates and immunocompromised patients.

2. How does regulatory perception impact the market potential of preservative-free opioids?
   Favorable regulatory scrutiny for safety-enhanced formulations can expedite approval processes and encourage payer reimbursement, boosting market penetration.

3. What are the main barriers to the growth of STADOL PRESERVATIVE FREE?
   Key challenges include stringent opioid regulations, market saturation with generics, societal stigma, and evolving prescribing guidelines aimed at curb misuse.

4. Can market dynamics favor the introduction of preservative-free opioids in emerging markets?
   Yes; expanding healthcare infrastructure, increasing surgical procedures, and growing awareness of safety issues can drive adoption, though cost and regulatory hurdles remain.

5. What strategic moves could optimize the financial trajectory for this drug?
   Investments in clinical research, early regulatory engagement, expanding indications, strategic partnerships, and targeted marketing emphasizing safety benefits are critical.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for industry: Safety considerations for preservative-free formulations.