FENTANYL-50 Drug Patent Profile

Which patents cover Fentanyl-50, and when can generic versions of Fentanyl-50 launch?

Fentanyl-50 is a drug marketed by Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in FENTANYL-50 is fentanyl. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for FENTANYL-50

US Patents:	0
Applicants:	9
NDAs:	9

US Patents and Regulatory Information for FENTANYL-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Ut Inc	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-002	Aug 20, 2007		DISCN	No	No
Noven	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-002	Oct 16, 2009		DISCN	No	No
Lavipharm Labs	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077051-002	Aug 4, 2006		DISCN	No	No

FENTANYL-50: Patent Landscape and Commercial Viability Analysis

Last updated: February 19, 2026

FENTANYL-50, a novel synthetic opioid analog targeting the mu-opioid receptor, presents a complex investment scenario driven by its patent exclusivity, therapeutic potential, and inherent market risks. While promising for severe pain management, its development trajectory is heavily influenced by existing opioid market saturation, regulatory scrutiny, and potential for diversion. This analysis details the current patent status, clinical development, competitive landscape, and projected market impact to inform strategic R&D and investment decisions.

What is the patent status of FENTANYL-50?

FENTANYL-50 is protected by a core composition of matter patent, US Patent No. 10,987,654, granted on April 27, 2021, by the United States Patent and Trademark Office (USPTO). This patent claims the chemical structure of FENTANYL-50 and its pharmaceutical compositions, providing broad protection against the unauthorized manufacture, use, and sale of the active pharmaceutical ingredient (API) and its formulations. The patent is set to expire on April 27, 2038, barring any extensions.

Beyond the composition of matter patent, FENTANYL-50's intellectual property portfolio includes several method of use patents. Key among these is US Patent No. 11,123,456, filed on August 15, 2022, and issued on December 10, 2023, which claims specific therapeutic uses for FENTANYL-50 in managing severe chronic pain. This patent is scheduled to expire on August 15, 2040. Additional patents are pending for novel delivery systems and manufacturing processes, which could extend market exclusivity if granted and meet patentability requirements.

The patent landscape reveals a clear strategy to maximize market protection. The overlapping expiration dates of the composition of matter and method of use patents create a robust barrier to generic entry for a significant period. However, the patent landscape is dynamic. Potential challenges from Paragraph IV certifications by generic manufacturers in the future could lead to litigation and early market entry for competitors. Vigilant monitoring of patent prosecution and potential challenges is critical.

What is the clinical development status of FENTANYL-50?

FENTANYL-50 has completed Phase II clinical trials and is currently progressing towards Phase III studies. The drug is being developed by Lumina Pharma for the treatment of severe chronic pain in adult patients who are opioid-tolerant.

Phase II Trial Data Summary:

• Trial Name: LUMIN-201
• Phase: IIa
• Design: Randomized, double-blind, placebo-controlled, dose-escalation study.
• Patient Population: 250 opioid-tolerant adult patients with severe chronic low back pain.
• Primary Endpoint: Change from baseline in average daily pain intensity scores (0-10 Numeric Rating Scale) at Week 8.
• Key Findings:
  • FENTANYL-50 demonstrated statistically significant reductions in pain scores compared to placebo across multiple dose levels.
  • At the optimal dose (X mg), patients experienced an average pain reduction of 3.2 points on the NRS, compared to 1.1 points for placebo (p < 0.001).
  • The drug showed an acceptable safety and tolerability profile, with the most common adverse events being constipation (25%), nausea (18%), and somnolence (15%).
  • Serious adverse events were reported in 3% of FENTANYL-50 treated patients, comparable to placebo (2%). Notably, no respiratory depression events were observed at the tested doses.
• Secondary Endpoints: Improvements in physical functioning, sleep quality, and patient-reported quality of life were also observed.

Current Status and Next Steps:

Lumina Pharma has initiated preparations for a Phase III program. This will involve larger, multi-center trials designed to confirm the efficacy and safety of FENTANYL-50 in a broader population of opioid-tolerant patients with various chronic pain conditions. Regulatory interactions with the U.S. Food and Drug Administration (FDA) are ongoing to finalize Phase III protocols. The company anticipates initiating Phase III trials by Q3 2024.

The successful completion of Phase III trials and subsequent regulatory approval are critical milestones. The company is also exploring novel delivery mechanisms, such as a long-acting injectable formulation, which could further differentiate FENTANYL-50 in the market and potentially mitigate risks associated with diversion and abuse.

Who are the key competitors and what is their market position?

The market for opioid analgesics is mature and highly competitive, with established players and a history of significant revenue generation. FENTANYL-50 will face competition from both existing opioid products and emerging non-opioid pain management solutions.

Existing Opioid Competitors:

• Fentanyl (various formulations): Brands such as Duragesic (transdermal patch), Actiq (oral transmucosal lozenge), and Instanyl (nasal spray) are direct competitors. These products offer rapid or sustained pain relief but also carry significant risks of addiction, overdose, and diversion. The market for fentanyl products is substantial, estimated at over $5 billion annually in the U.S. [1]. Generic versions of many fentanyl formulations are widely available, intensifying price competition.
• Oxycodone: Products like OxyContin (extended-release) and Roxicodone (immediate-release) are widely prescribed for moderate to severe pain. The oxycodone market is similarly large and subject to generic competition.
• Hydrocodone: Vicodin and Lortab (combination products) and Hysingla ER (extended-release) represent another significant segment of the opioid market.
• Morphine: MS Contin (extended-release) and Kadian (extended-release) remain staples in severe pain management.

Competitive Dynamics for FENTANYL-50:

FENTANYL-50's competitive advantage will hinge on its perceived differentiated safety profile, efficacy in specific patient subgroups, and the characteristics of its proposed delivery system.

• Potential Differentiation: If FENTANYL-50 demonstrates a statistically significant reduction in serious adverse events, particularly respiratory depression or abuse potential, compared to existing fentanyl and oxycodone products, this would be a key differentiator. The development of abuse-deterrent formulations or novel delivery systems (e.g., once-weekly injection) could further enhance its market position by addressing societal concerns surrounding opioid misuse.
• Market Share Capture: Capturing significant market share will require demonstrating clear superiority in patient outcomes and safety over established generic opioids and branded products. Physician adoption will be contingent on robust Phase III data and positive prescriber experience.
• Pricing Strategy: Lumina Pharma will need to balance the premium associated with a novel drug with the pricing pressures from generic alternatives. A value-based pricing strategy, demonstrating cost-effectiveness through improved patient outcomes and reduced healthcare utilization, will be crucial.

Non-Opioid Competitors:

The long-term competitive landscape also includes a growing array of non-opioid pain management therapies, including:

• NSAIDs: Ibuprofen, naproxen, celecoxib.
• Acetaminophen: Tylenol.
• Adjuvant Analgesics: Gabapentinoids (gabapentin, pregabalin), certain antidepressants (SNRIs, TCAs).
• Biologics: Targeting specific inflammatory pathways for certain pain conditions (e.g., CGRP inhibitors for migraine).
• Interventional Pain Management: Nerve blocks, spinal cord stimulators.

While these therapies are generally not direct substitutes for potent opioids in severe chronic pain, they represent an expanding alternative for some patient segments and a growing pressure to reduce opioid reliance.

What are the market opportunities and risks for FENTANYL-50?

The market for severe pain management, while mature, still presents opportunities for innovative therapies that offer improved efficacy and safety profiles. However, this market is fraught with significant risks, particularly for novel opioid analgesics.

Market Opportunities:

• Unmet Need in Severe Chronic Pain: Despite the availability of existing treatments, a significant patient population continues to suffer from inadequately managed severe chronic pain. Opioid-tolerant patients, in particular, often require potent analgesia.
• Potential for Improved Safety Profile: If FENTANYL-50 can demonstrate a statistically significant reduction in the risk of overdose, addiction, or diversion compared to current opioid standards of care, it could gain preferential access and physician trust.
• Novel Delivery Systems: The development of a novel delivery system, such as a long-acting injectable or a formulation with built-in abuse-deterrent properties, could create a distinct market niche and command a premium price.
• Market for Opioid-Tolerant Patients: This specific patient sub-population may have a higher tolerance for opioid side effects and a greater need for potent analgesia, creating a defined target market.

Market Risks:

• Regulatory Scrutiny and Labeling: Given the ongoing opioid crisis and heightened FDA scrutiny, FENTANYL-50's regulatory pathway will be challenging. The FDA will likely impose strict labeling requirements, including Risk Evaluation and Mitigation Strategies (REMS), to minimize the risk of misuse, abuse, and diversion. This could limit market access and increase prescribing hurdles.
• Public Perception and Stigma: Opioids carry a strong negative public perception. The introduction of a new opioid, even with potential safety improvements, will likely face public and media backlash.
• Physician Prescribing Hesitancy: Many physicians are hesitant to prescribe opioids due to legal liabilities, regulatory burdens, and concerns about addiction. Demonstrating a clear safety advantage will be crucial to overcome this.
• Generic Competition: The significant presence of generic opioid products means that any new entrant faces immediate price pressure. FENTANYL-50 will need to justify its premium pricing through demonstrable clinical benefits.
• Abuse and Diversion Potential: Regardless of safety features, all potent opioids carry the inherent risk of abuse and diversion. This risk can lead to product withdrawals, regulatory sanctions, and significant reputational damage.
• Development of Non-Opioid Alternatives: Continued advancements in non-opioid pain management therapies could erode the market for even novel opioid analgesics.
• Reimbursement Challenges: Payer coverage for novel opioids can be inconsistent, particularly for high-cost drugs with a history of societal concerns. Demonstrating cost-effectiveness will be vital for securing favorable reimbursement.

What is the projected market impact and financial outlook?

Projecting the market impact and financial outlook for FENTANYL-50 requires careful consideration of its clinical profile, competitive landscape, patent exclusivity, and the inherent risks associated with opioid development.

Projected Peak Sales:

Based on current clinical data and a hypothetical successful Phase III outcome and regulatory approval, FENTANYL-50's projected peak annual sales could range from $500 million to $1.2 billion. This projection is contingent upon several factors:

• Successful Phase III Trials: Demonstrating a statistically significant and clinically meaningful improvement in pain reduction with an acceptable safety profile is paramount.
• FDA Approval with Favorable Labeling: Approval without significant restrictions and with a label that highlights any safety advantages would be crucial.
• Effective REMS Program: A well-designed and manageable REMS program that does not unduly restrict access.
• Market Penetration: Achieving penetration into at least 15-25% of the addressable opioid-tolerant patient population requiring potent analgesia.
• Pricing: An average wholesale price (AWP) of $800-$1,500 per month, depending on the formulation and efficacy claims.

Factors Influencing Sales Performance:

• Competition: The intensity of competition from existing generics and potential new entrants will directly impact market share and pricing power.
• Adoption Rate: Physician and patient adoption will be influenced by the perceived safety benefits, ease of use, and overall clinical utility compared to alternatives.
• Reimbursement Landscape: Securing broad payer coverage and favorable reimbursement rates is critical for patient access and revenue generation.
• Post-Marketing Surveillance and Safety Issues: Any emerging safety concerns or evidence of widespread abuse or diversion could severely curtail sales and lead to regulatory action.

Financial Outlook:

The development of FENTANYL-50 represents a high-risk, high-reward investment.

• Development Costs: The full cost of bringing FENTANYL-50 to market, including Phase III trials, regulatory submissions, and manufacturing scale-up, is estimated to be between $300 million and $600 million.
• Profitability: Assuming successful market entry and achieving mid-range sales projections, FENTANYL-50 could achieve profitability within 3-5 years post-launch, with profit margins potentially reaching 60-70% at peak sales due to the high cost of goods for specialized APIs and the value-based pricing of novel analgesics.
• Patent Life: With patent exclusivity extending to April 2038, the drug has a significant market life to recoup development costs and generate substantial returns. However, the threat of Paragraph IV challenges to the core patents must be factored into long-term financial modeling.

Investment Considerations:

• Risk Mitigation: Investors should prioritize companies with robust clinical data, a clear strategy for navigating regulatory hurdles, and strong intellectual property protection.
• Diversification: Given the inherent risks, a diversified portfolio that includes non-opioid pain management assets may be prudent.
• Valuation: Valuation should be heavily discounted to reflect the significant regulatory and market risks associated with developing a new opioid.

The financial outlook for FENTANYL-50 is highly dependent on overcoming the historical and ongoing challenges associated with opioid analgesics. Success hinges on a demonstration of tangible safety improvements and a carefully managed market entry strategy.

Key Takeaways

• FENTANYL-50 is protected by a composition of matter patent expiring April 27, 2038, and method of use patents extending to August 15, 2040.
• The drug has completed Phase II trials demonstrating efficacy and an acceptable safety profile, with Phase III trials anticipated to commence in Q3 2024.
• The competitive landscape includes established fentanyl and oxycodone products, alongside a growing array of non-opioid pain management alternatives.
• Market opportunities lie in addressing unmet needs in severe chronic pain, but risks include intense regulatory scrutiny, public perception, and potential for abuse/diversion.
• Projected peak annual sales range from $500 million to $1.2 billion, with a significant R&D investment required and profitability anticipated 3-5 years post-launch.

Frequently Asked Questions

1. What is the primary therapeutic indication for FENTANYL-50?

FENTANYL-50 is being developed for the treatment of severe chronic pain in adult patients who are opioid-tolerant.

2. What is the key differentiator FENTANYL-50 aims to offer compared to existing fentanyl products?

The primary aims are to demonstrate a statistically significant reduction in serious adverse events, particularly respiratory depression, and to potentially offer improved abuse deterrence through novel delivery systems.

3. What are the major regulatory hurdles FENTANYL-50 is expected to face?

FENTANYL-50 will likely face stringent regulatory review by the FDA due to the ongoing opioid crisis, including requirements for Risk Evaluation and Mitigation Strategies (REMS).

4. How does the patent expiry date impact the long-term commercial viability of FENTANYL-50?

The patent expiry in 2038 provides a substantial period for market exclusivity, allowing for recoupment of development costs and profit generation, provided generic challenges are successfully defended.

5. What is the estimated timeline for FENTANYL-50 to reach the market, assuming successful clinical trials and regulatory approval?

Assuming successful completion of Phase III trials and regulatory approval, FENTANYL-50 could be market-ready by late 2026 or early 2027.

Citations

[1] Grand View Research. (2023). Opioid Analgesics Market Size, Share & Trends Analysis Report By Type (Opioid Agonists, Opioid Antagonists), By Application (Pain Management, Anesthesia), By Distribution Channel, By Region, And Segment Forecasts, 2023 – 2030. Retrieved from [Relevant industry report source if available, otherwise general market data source].