Last updated: July 28, 2026
ULTIVA is branded remifentanil hydrochloride, an IV opioid used for perioperative anesthesia. The investment case is driven by (1) remifentanil’s limited “brand-like” defensibility in the US, (2) generic and authorized-typical supply dynamics, and (3) whether any remaining formulation, method-of-use, or supply-chain IP can delay competition. On available public information for remifentanil, the base molecule and core indications are widely off-patent in major markets, making brand economics heavily dependent on tender pricing, distribution access, and any late-cycle lifecycle IP.
What is ULTIVA (remifentanil hydrochloride) and how is it used clinically?
Featured snippet: ULTIVA is IV remifentanil hydrochloride, a short-acting, potent μ-opioid receptor agonist used for induction and maintenance of anesthesia and procedural sedation as part of monitored anesthesia care.
ULTIVA is marketed as remifentanil hydrochloride injection (commonly supplied as a lyophilized powder for reconstitution, dosed by weight and titration). In perioperative settings, remifentanil is used to:
- support anesthesia induction and maintenance,
- provide analgesia during surgery,
- control analgesic depth during procedures requiring rapid onset/offset.
Key commercial implications of clinical profile
- Rapid offset supports operating room scheduling and recovery efficiency narratives, but these do not typically prevent generic entry.
- Controlled substance labeling and handling costs raise barriers for new entrants, but they do not create durable patent exclusivity.
What is the revenue and market size exposure for remifentanil brands like ULTIVA?
Featured snippet: ULTIVA revenue is exposed to generic substitution, hospital formulary management, and procurement pricing rather than patent-driven monopoly.
Market structure (investment lens)
- Remifentanil is used in anesthesia across hospitals and ambulatory surgical centers, with adoption tied to:
- anesthesia provider preference,
- procurement contracts,
- inventory management,
- availability during shortages.
- Brand profitability typically compresses when generics gain share, especially in competitive tenders.
Investment scenario factors
- If a brand is late-cycle and already subject to broad generic penetration, new growth usually comes from:
- expanded access through group purchasing organization (GPO) contracts,
- tender wins in geographies where supply is stable,
- lifecycle differentiation where relevant (presentation, stability, concentration, reconstitution workflow).
What patents protect ULTIVA (remifentanil) in the US and globally?
Featured snippet: Core remifentanil IP is largely exhausted; remaining defensibility usually comes from formulation, process, or packaging claims rather than the active ingredient or core use.
Because “ULTIVA” is the brand for remifentanil hydrochloride, the relevant IP estate typically includes:
- active ingredient composition-of-matter (earlier generation, generally long expired),
- method-of-use claims (specific regimens, anesthesia protocols, or titration schemes),
- formulation claims (for example, excipient systems, concentration/presentation),
- manufacturing/process claims (crystallization, purification, sterile manufacturing),
- packaging/storage system claims (less common, but can matter for stability),
- regulatory exclusivity tied to specific approved labeling and applications.
Business impact
- If no enforceable composition-of-matter or method-of-use IP remains, then price and supply economics dominate.
- If there are formulation or process claims still in-force in a target geography, they can delay generic substitution but rarely sustain long-term brand premium in mature controlled-substance markets.
When does ULTIVA lose exclusivity (US Orange Book timeline and patent expiration drivers)?
Featured snippet: ULTIVA’s exclusivity timeline is typically dominated by patent expirations and any granted regulatory exclusivities tied to a specific NDA supplement; the base substance is widely off-patent.
How to model exclusivity in an investment case
- Build a “last legally effective date” stack:
- listed patents expiring dates (Orange Book),
- pediatric exclusivity or other statutory extensions,
- exclusivity from supplemental approvals if still applicable,
- any patent term adjustments or litigation-driven stays.
- Then overlay:
- generic ANDA or “authorized generic” strategies,
- labeling carve-outs for safety/administration differences,
- supply constraints that can keep brand share unusually high.
Investment implication
- For remifentanil, the most likely base case is that brand exclusivity has already ended or is late-cycle.
- The “bear” case usually assumes aggressive generic penetration post-expiration with hospital procurement switching.
How many ANDA filings and generic entry risks exist for remifentanil products like ULTIVA?
Featured snippet: Generic entry risk is high for remifentanil because the active ingredient is established and mature; the main uncertainty is whether any remaining formulation or process patents block specific presentations.
Risk components
- ANDA approval does not automatically translate to immediate market capture. A generic’s commercial success depends on:
- tender readiness,
- sufficient manufacturing capacity,
- controlled-substance supply compliance,
- interchangeability in formularies.
Investment lens
- The most meaningful competitor map is not just “generics exist,” but:
- which products are stocked by hospital systems,
- which suppliers win GPO contracts,
- whether there are recurring supply disruptions among key generic players.
What Paragraph IV challenges affect ULTIVA and remifentanil generics?
Featured snippet: Paragraph IV challenges can affect timing of generic launches if remifentanil still has enforceable late-cycle patents, but for mature active ingredients the probability is generally low that unresolved estates still create broad, durable barriers.
A structured litigation-risk model should include:
- whether remifentanil patents were challenged via ANDA Paragraph IV,
- any 30-month stay impact,
- settlement entry dates and “authorized generic” relationships.
Investment implication
- If there is no active or recent Paragraph IV patent litigation, then the generic launch schedule is mostly driven by:
- patent expiry,
- regulatory review timelines,
- manufacturing and supply readiness.
What patent litigation affects ULTIVA and remifentanil in the last 10 years?
Featured snippet: Investment relevance comes from whether litigation created delayed generic entry or supply settlement agreements; for remifentanil, litigation is typically not the dominant driver once the core estate is exhausted.
For a litigation-driven underwriting, you would normally track:
- filed lawsuits by ANDA filers,
- court dates and claim construction outcomes,
- settlement terms: design-around scope, launch dates, and territory.
Investment implication
- If litigation is absent or resolved without long stays, then the market tends to transition quickly to price competition.
How strong is the patent estate for remifentanil compared with other perioperative anesthetics?
Featured snippet: Remifentanil’s patent strength is generally weaker than newer anesthetic or analgesic franchises because the molecule is mature; competitive differentiation is usually operational, not IP-driven.
Benchmark comparison (investment framing)
- Newer anesthetic opioids or adjuncts with still-active composition-of-matter typically have:
- higher exclusivity duration,
- more defensible subpopulations or specialized dosing regimens,
- higher odds of long-lasting brand premium.
- Mature remifentanil typically relies on:
- clinical workflow fit,
- distribution leverage,
- tender pricing.
Underwriting conclusion
- For remifentanil brands, expect less pricing power and more reliance on execution.
What formulations are protected for ULTIVA (excipients, concentration, and delivery system patents)?
Featured snippet: Remaining IP, if any, is more likely in formulation/process claims than in core active ingredient claims.
Formulation protection matters because it can affect:
- reconstitution procedure,
- solution concentration,
- stability during storage and infusion,
- compatibility with common anesthesia workflows.
Commercial impact
- Even modest formulation restrictions can slow generic swap if hospitals perceive administration differences or if clinicians insist on specific presentations for routine anesthesia packs.
How does ULTIVA compare with remifentanil competitor brands and authorized generics?
Featured snippet: For remifentanil, the competitive set is largely “generic-equivalent price and supply,” with minor differences in presentation and availability.
What to compare in an investment dashboard
- brand vs generic price gap in tenders,
- number of stocked SKUs per hospital system,
- wholesaler and distributor stocking frequency,
- contract shelf-life and delivery terms,
- backup supply arrangements during shortages.
What is the FDA regulatory status of ULTIVA and remifentanil products (NDA/ANDA pathway)?
Featured snippet: ULTIVA is approved via the NDA pathway; generic versions are typically pursued via ANDAs for pharmaceutically equivalent remifentanil formulations.
Investment relevance:
- If the branded labeling is mature and widely shared by generics, regulatory status rarely blocks substitutes.
- Any labeling exclusivity specific to a supplement can matter, but this is uncommon for very mature products unless a new indication or administration change was granted.
What Orange Book status does ULTIVA have, and which patents are listed?
Featured snippet: The Orange Book listing determines generic eligibility timing; for remifentanil brands like ULTIVA, the active ingredient’s composition-of-matter is generally not the gating item in later years.
A complete Orange Book-driven model must map:
- all listed drug product patents to their expiration dates,
- pediatric extensions,
- any court-ordered stays.
Investment lens
- If Orange Book lists only expired or near-expiry patents, generic substitution typically proceeds quickly.
- If any unexpired formulation or method patents exist, the timing and probability of launch should be tied to those specific entries.
What biosimilar risk exists for ULTIVA?
Featured snippet: None. ULTIVA is a small-molecule opioid, not a biologic.
Unlike antibodies or recombinant proteins, remifentanil does not face biosimilar pathways (BLA/351(k)). Risk is ANDA-based generic substitution, not biosimilar competition.
What manufacturing and supply-chain IP barriers exist for remifentanil generics?
Featured snippet: The main barriers are operational and regulatory (sterile manufacturing, controlled-substance compliance), not high IP hurdles at this stage.
Key operational determinants
- sterile injectable manufacturing capacity,
- validated reconstitution and stability processes,
- documentation for controlled-substance distribution,
- logistics to hospitals with tight OR scheduling.
Investment implication
- A “quality + supply reliability” differentiation can preserve some share even after IP expiry.
What generic entry scenarios are most likely for ULTIVA in the next 12–36 months?
Featured snippet: The most likely scenario is continued price pressure with incremental share shifts to stocked generics; the tail risk is supply disruption among generic vendors that temporarily lifts branded demand.
Scenario set
- Base case: stable generic share growth; brand share gradually erodes; margin compresses.
- Downside: rapid tender-driven switching; accelerated price gap; brand volumes decline faster than expected.
- Upside: supply tightness among competitors or tender awards to brand; temporary retention of market share and better gross margin.
What commercial strategy can protect ULTIVA profitability if patents are weak?
Featured snippet: Profit protection is procurement and supply-chain execution, not patent leverage.
Commercial levers:
- tender contract structure (volume commitments, delivery SLAs),
- service levels and availability guarantees,
- hospital education on reconstitution workflow if any presentation differences exist,
- inventory management to avoid stockouts,
- targeted contracting in hospital networks with stable anesthesia protocols.
Key Takeaways
- ULTIVA is remifentanil hydrochloride, a mature perioperative opioid whose economics depend more on generic substitution and procurement than on long-lived patent exclusivity.
- Patent-driven defensibility, if present, is most likely limited to formulation or process claims, not the core active ingredient.
- The investment risk is primarily generic ANDA competition tied to expiration and any remaining unexpired IP listings; litigation can delay entry but usually is not the dominant driver at this stage for mature remifentanil.
- Upside is operational: tender wins, supply reliability, and maintaining preferred formulary status.
- Downside is price compression and rapid hospital switching to stocked generics post-expiration.
FAQs
1) Are there any remaining unexpired remifentanil patents that could delay generic substitution of ULTIVA?
Generic delay depends on unexpired Orange Book-listed patents tied to specific remifentanil presentations; in mature markets, these are typically formulation or method/process claims rather than core composition-of-matter.
2) Does ULTIVA face biosimilar competition?
No. Remifentanil is a small molecule and is not eligible for biosimilar pathways.
3) What drives hospital switching from branded remifentanil to generic?
Pricing in tenders, SKU interchangeability perceptions, supply reliability, and distribution availability.
4) What regulatory pathway do generics use for remifentanil products?
Typically ANDA pathways for pharmaceutically equivalent remifentanil formulations.
5) How should an investor underwrite margin risk for ULTIVA specifically?
Model gross margin compression tied to tender price diffusion and volume substitution, then adjust for supply interruptions that can temporarily favor the branded product.
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. ANDA and 505(j) pathway materials (general regulatory framework). U.S. Food and Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
- FDA. REMS and controlled substance distribution framework (general). U.S. Food and Drug Administration. https://www.fda.gov/
