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droperidol; fentanyl citrate - Profile
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What are the generic sources for droperidol; fentanyl citrate and what is the scope of patent protection?
Droperidol; fentanyl citrate
is the generic ingredient in two branded drugs marketed by Astrazeneca, Hospira, and Epic Pharma Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Summary for droperidol; fentanyl citrate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 5 |
US Patents and Regulatory Information for droperidol; fentanyl citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | FENTANYL CITRATE AND DROPERIDOL | droperidol; fentanyl citrate | INJECTABLE;INJECTION | 072026-001 | Apr 13, 1989 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Astrazeneca | FENTANYL CITRATE AND DROPERIDOL | droperidol; fentanyl citrate | INJECTABLE;INJECTION | 072027-001 | Apr 13, 1989 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Astrazeneca | FENTANYL CITRATE AND DROPERIDOL | droperidol; fentanyl citrate | INJECTABLE;INJECTION | 072028-001 | Apr 13, 1989 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Droperidol + Fentanyl Citrate: Investment Scenario and Fundamentals Analysis
What are droperidol and fentanyl citrate, and where do they sit in the care pathway?
Droperidol is a butyrophenone antipsychotic used clinically for antiemetic effects (e.g., prevention/treatment of nausea and vomiting) and for sedation in procedural settings.
Fentanyl citrate is a synthetic opioid agonist used for analgesia and anesthesia, including procedural sedation and perioperative pain control.
Product investment relevance: the combination of droperidol and fentanyl citrate is typically driven by (1) procedural sedation and pain protocols where antiemetic prophylaxis is valued and (2) hospital formularies that favor predictable peri-procedural outcomes (pain control plus reduced emesis).
Which indications and endpoints matter for commercial durability?
Indication stack (primary)
- Perioperative/procedural sedation and analgesia: fentanyl drives analgesia; droperidol supports sedation adjunct and antiemetic intent.
- Nausea and vomiting prevention/treatment: droperidol is a clinically used antiemetic option in appropriate settings.
Commercial endpoints that influence adoption
- Dose stability and titration reliability in procedural workflows.
- Antiemetic efficacy that reduces rescue therapy and downstream treatment costs.
- Safety profile management focused on known risks:
- For droperidol: QT prolongation signaling has historically shaped labeling and institutional controls.
- For fentanyl: respiratory depression risk underpins monitoring requirements.
How does the regulatory and labeling landscape affect uptake?
Key practical constraint: controlled use and monitoring
- Hospital adoption is monitoring-driven for opioids and QT-risk management for droperidol.
- Formulary outcomes depend on whether the product includes clear clinical instructions for:
- titration,
- monitoring,
- contraindications,
- and QT-related precautions.
How this translates into investment fundamentals
- Products that can be placed with standard operating procedures (SOPs) face fewer adoption frictions.
- Adoption is typically higher when procurement and pharmacy workflow are simpler:
- clear dosing instructions,
- readily integrated administration practices,
- minimal need for exceptional monitoring beyond standard anesthesia/sedation protocols.
(Regulatory details are product- and jurisdiction-specific; investment planning should map the exact marketed label to local facility requirements.)
What does the patent and exclusivity posture usually imply for revenue risk?
Droperidol and fentanyl are mature actives. For investment scenarios, the dominant revenue risk is rarely clinical failure of the actives and more often:
- product-level patent cliffs (formulation, method-of-use, combination, or manufacturing process),
- regulatory exclusivity expiration in key markets,
- and generic/biosimilar-style competition for classic small-molecule segments.
Investment implication
- The “protectable” economic value is usually located in:
- proprietary formulation (if present),
- proprietary combination presentation (if present),
- and proprietary method-of-use or dosing regimen claims (if they were secured and are enforceable).
Without product-level claim survivability, long-hold forecasts should discount sharply after exclusivity windows close.
(Patent counsel and prosecution history are required for claim-level underwriting; absent that, only structural risks can be stated.)
How do competitors and alternative-of-choice dynamics shape market access?
Competitive substitution patterns
- Antiemetic alternatives: providers often substitute between droperidol and other antiemetic regimens depending on local protocols and safety controls.
- Analgesic/opioid alternatives: fentanyl competes with other peri-procedural opioids and anesthesia agents based on onset, monitoring burden, and institutional preferences.
What matters for share retention
- Formulary retention rises when the product:
- reduces rescue antiemetic use,
- integrates with sedation pathways,
- and supports clinician confidence in safety controls.
What are the key drivers of sales traction in hospitals and ambulatory settings?
Driver 1: protocol fit
- Procedural sedation units and perioperative teams select regimens that are:
- easy to stock and administer,
- compatible with existing monitoring workflows,
- and supported by consistent dosing guidance.
Driver 2: outcomes and operational efficiency
- Lower rates of emesis and reduced rescue interventions can convert into:
- faster patient recovery,
- fewer repeat visits,
- lower drug waste and fewer procedural extensions.
Driver 3: supply and contracting
- Value is strongly influenced by:
- ability to maintain consistent supply,
- GPO/IDN contracting,
- and pricing stability relative to alternates.
What is the market adoption friction profile for droperidol + fentanyl citrate?
Likely friction points
- QT risk governance for droperidol: hospitals may require ECG screening or risk stratification in protocols.
- Opioid monitoring for fentanyl: facilities require staff training, monitoring equipment, and reversal agent readiness.
Likely friction reducers
- Clear label-based dosing and monitoring instructions.
- Product packaging and administration formats that reduce setup time and medication errors.
Underwriting takeaway
- Facilities often decide based on operational feasibility, not only clinical efficacy.
What are the investment scenarios: base, bear, and bull?
The scenarios below underwrite revenue behavior using common small-molecule, protocol-driven dynamics: mature actives, product-level exclusivity/patent dependence, and strong substitution.
Scenario design (revenue and risk)
| Scenario | Assumptions (core) | Expected revenue trajectory | Primary downside |
|---|---|---|---|
| Bull | Strong protocol fit, stable hospital contracts, and product-level protections extend key markets longer than expected | Moderate-to-strong penetration and retention | Slower-than-planned generic entry or alternative substitution |
| Base | Adoption continues but substitution increases gradually; product protections are limited to certain geographies or time windows | Steady growth then plateau | Patent/exclusivity timing is earlier than forecast |
| Bear | Generic or competing formulations/combinations enter key formularies; contracts shift to alternatives | Rapid margin compression; possible volume decline | Fast market share loss and pricing pressure |
Where is the value concentrated: product, claims, or supply chain?
Product-level value levers
- Combination presentation: if the exact droperidol + fentanyl citrate pairing is proprietary in presentation or administration, that can slow substitution.
- Formulation and stability: improved shelf-life or handling can matter more than clinicians realize.
Claim-based value lever
- Method-of-use claims (if they exist and are enforceable) can protect market position even after basic actives become generic.
Supply-chain lever
- Hospital purchasing favors reliable supply. Stock-outs or allocation constraints can permanently damage formulary standing.
What should investors measure each quarter to validate the thesis?
Clinical adoption and volume signals
- Hospital and health system contract wins and renewal patterns.
- Formulary tier placement changes (preferred vs. restricted).
- Use metrics in perioperative/procedural sedation workflows.
Commercial margin signals
- Net price trend versus:
- antiemetic comparators,
- other opioids used in similar sedation pathways.
- Manufacturing cost stability and gross margin compression from competitive pricing.
Risk signals tied to regulation and governance
- Updates to QT-related institutional protocols for droperidol.
- Any changes in opioid monitoring requirements that affect administration and staffing costs.
Key diligence checklist for a deal or investment
- Product specificity: confirm the exact marketed product configuration (strengths, presentation, and indicated use).
- Protection mapping: identify product-level patent families and exclusivity status by major markets.
- Competitor set: map direct substitution options for both antiemetic and peri-procedural analgesia roles.
- Institutional protocol fit: evaluate whether the product aligns to standard monitoring and ECG governance procedures.
- Commercial traction: review channel relationships, contracting cadence, and formulary placement.
Key Takeaways
- Droperidol + fentanyl citrate is a protocol-driven peri-procedural proposition where adoption depends on operational fit: antiemetic intent plus opioid analgesia under monitoring.
- Revenue durability is primarily product-level, not active-level, because both actives are mature; the key underwriting variable is combination/presentation/formulation protection and claim survivability.
- Institutional governance is a central determinant of uptake: QT-risk management for droperidol and respiratory monitoring for fentanyl drive formulary acceptance.
- Competitive substitution risk is structural, so the investment edge must come from contract placement, reliable supply, and enforceable product differentiation.
FAQs
1) Is this an asset likely to face rapid competitive substitution?
Yes. Both actives are mature, and substitution typically accelerates when product-level protections expire or fail to block formulary switches.
2) What is the most important nonclinical factor for hospital adoption?
Hospital monitoring and protocol integration. QT governance and opioid monitoring requirements shape ease of prescribing and administration.
3) Does the investment case depend more on clinical trial success or IP strength?
For droperidol + fentanyl citrate, IP and product-level differentiation typically carry more weight than incremental clinical performance because the actives are established.
4) What contract dynamics matter most?
GPO/IDN contracting and tier placement (preferred vs. restricted). Even modest pricing erosion can materially compress margin if competitors displace volume.
5) What should investors watch for quarter to quarter?
Net price trend, formulary tier movement, and volume stability in perioperative/procedural sedation settings, alongside any changes in monitoring protocols that affect administration costs.
References
[1] U.S. Food and Drug Administration. FDA Drug Safety Communications and labeling resources for droperidol and opioids (general database access for labeling and safety communications). FDA website. https://www.fda.gov/drugs
[2] U.S. National Library of Medicine. Drugs@FDA (product labeling and history for approved drug products). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. EPARs and product information for centrally authorized medicines (general database). https://www.ema.europa.eu/en/medicines
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