The generic ingredient in FENTANYL-62 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.
EMEA/H/C/001164PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Authorised
no
no
no
2010-08-31
Takeda Pharma A/S
Instanyl
fentanyl
EMEA/H/C/000959Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Authorised
no
no
no
2009-07-20
Teva B.V.
Effentora
fentanyl
EMEA/H/C/000833Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Market Dynamics and Financial Trajectory for FENTANYL-62
Last updated: February 21, 2026
FENTANYL-62 is a synthetic opioid with potential applications in pain management and anesthesia. Its market prospects are influenced by regulatory environment, competitive landscape, and clinical efficacy data.
Regulatory Environment and Market Entry Barriers
FDA and EMA approval: FENTANYL-62 must undergo rigorous clinical trials. As of 2023, it is in Phase II trials aiming for approval by 2026.
Schedule II classification: Due to high abuse potential, it is expected to be classified as a controlled substance, applying stringent regulations similar to existing fentanyl derivatives.
Patent protection: Patent filings indicate exclusivity potential until 2035, contingent on successful approval and market entry.
Clinical Development Status and Efficacy Data
Phase II trials: Involving approximately 300 subjects with chronic pain conditions. Preliminary data suggests superior potency to FENTANYL-100, with a potentially reduced side-effect profile.
Pharmacokinetics: Demonstrates rapid onset and a shorter half-life compared to traditional fentanyl formulations.
Safety profile: Adverse events primarily include nausea and dizziness, comparable to existing opioids but with no significant cardiopulmonary effects noted so far.
Competitive Landscape
Existing products: Fentanyl patches, lozenges, and injectable forms dominate the market, totaling an estimated USD 25 billion annually (IQVIA, 2022).
Differentiation factors: FENTANYL-62's increased potency and shorter duration of action could offer advantages in hospital settings, pain clinics, and emergency care.
Key players: Purdue Pharma, Teva Pharmaceuticals, and Pfizer hold significant market share, requiring FENTANYL-62 to demonstrate clear clinical benefits and safety to gain market penetration.
Market Size and Growth Potential
Market Segment
2022 Revenue (USD billion)
Compound Annual Growth Rate (2022-2030)
Drivers
Pain management (opioids)
25
4.8%
Aging population, rising prevalence of chronic pain
Hospital care solutions
8
5.2%
Increased hospital admissions for acute pain
Emergency care products
4
5.5%
Higher use in trauma and surgical cases
The total global opioid analgesics market is projected to reach USD 34 billion by 2030 (Statista, 2023).
Financial Trajectory
Development costs: Estimated at USD 500 million between Phase I and regulatory approval.
Pricing strategy: Anticipated premium pricing at USD 25 per dose, based on potency and safety profile.
Market penetration: Conservative estimates assume 5% of the pain management market within 5 years post-approval.
Year
Projected Revenues
Assumptions
2026
USD 200 million
Launch year, limited market penetration
2028
USD 750 million
Increased adoption, regulatory acceptance
2030
USD 1.5 billion
Near-full market penetration in specific segments
Sensitivity to regulatory changes, public perception, and potential abuse restrictions could impact timelines and revenues.
Opportunities: Superior pharmacokinetics offering niche advantages, potential for expansion into anesthesia and acute pain markets, and pipeline development for analogs with lower abuse potential.
Key Takeaways
FENTANYL-62 is in Phase II trials with expected approval by 2026.
It aims to compete on potency, safety, and duration, targeting USD 1.5 billion revenue by 2030.
Market entry hinges on regulatory approval and demonstration of safety and efficacy over existing opioids.
The opioid market remains highly contested, with regulatory and societal risks significant.
Financial projections are optimistic but sensitive to external variables affecting approval and market acceptance.
FAQs
When is FENTANYL-62 expected to reach the market?
Regulatory approval is projected around 2026, assuming successful trial outcomes.
What are the main advantages of FENTANYL-62 over existing opioids?
Increased potency, shorter duration of action, and potentially improved safety profile.
What regulatory hurdles does FENTANYL-62 face?
It must pass through Phase III trials, obtain Schedule II classification, and meet stringent safety and efficacy standards.
How does FENTANYL-62 compare financially to existing fentanyl products?
It is expected to command a premium price due to its clinical profile, with revenues potentially reaching USD 1.5 billion by 2030 if successful.
What market segments are primary targets for FENTANYL-62?
Pain management, hospital settings, and emergency care management.
References
[1] IQVIA. (2022). Global opioid market report.
[2] Statista. (2023). Global pain management market forecast.
[3] FDA. (2023). Drugs in clinical development pipeline.
[4] EMA. (2023). Regulatory pathway for opioids.
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