ULTIVA Drug Patent Profile

Which patents cover Ultiva, and what generic alternatives are available?

Ultiva is a drug marketed by Mylan Institutional and is included in one NDA.

The generic ingredient in ULTIVA is remifentanil hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultiva

A generic version of ULTIVA was approved as remifentanil hydrochloride by FRESENIUS KABI USA on January 16^th, 2018.

Summary for ULTIVA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	99
Patent Applications:	6,011
Drug Prices:	Drug price information for ULTIVA
What excipients (inactive ingredients) are in ULTIVA?	ULTIVA excipients list
DailyMed Link:	ULTIVA at DailyMed

See drug prices for ULTIVA

Recent Clinical Trials for ULTIVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Siirt Training and Research Hospital	PHASE4
QPS	Phase 1
Paion UK Ltd.	Phase 1

See all ULTIVA clinical trials

Pharmacology for ULTIVA

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for ULTIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTIVA	for Injection	remifentanil hydrochloride	1 mg/vial, 2 mg/vial and 5 mg/vial	020630	1	2013-12-27

US Patents and Regulatory Information for ULTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	AP	RX	Yes	No
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	AP	RX	Yes	No
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	AP	RX	Yes	Yes

International Patents for ULTIVA

See the table below for patents covering ULTIVA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	140451
Australia	4973190
Australia	636330
Canada	2010011	N-PHENYL-N-(4-PIPERIDINYL) AMIDES UTILES COMME ANALGESIQUES (N-PHENYL-N-(4-PIPERIDINYL) AMIDES USEFUL AS ANALGESICS)
Cyprus	2002	N-Phenyl-N-(4-piperidinyl) amides useful as analgesics
Czech Republic	9104025
Germany	19675028

Supplementary Protection Certificates for ULTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0383579	SZ 34/1996	Austria		PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID
0383579	SPC/GB96/059	United Kingdom		PRODUCT NAME: REMIFENTANIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT, INCLUDING REMIFENTANIL HYDROCHLORIDE; REGISTERED: DE 36335.00.00 19960517; DE 36335.01.00 19960517; DE 36335.02.00 19960517; UK 14213/0002 19961030; UK 14213/0003 19961030; UK 14213/0004 19961030
0383579	19675028	Germany		PRODUCT NAME: REMIFENTANIL SOWIE PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, EINSCHLIESSLICH REMIFENTANILHYDROCHLORID; REGISTRATION NO/DATE: 36335.00.00 36335.01.00 36335.02.00 19960517
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0383579	97C0029	Belgium		PRODUCT NAME: REMIFENTANILUM HYDROCHLORIDUM (= REMIFENTANILUM BASIS); NAT. REGISTRATION NO/DATE: 725 IS 146 F 12 19970408; FIRST REGISTRATION: DE 36.335.00.00 19960517

Last updated: July 29, 2026

ULTIVA (remifentanil): Market dynamics and financial trajectory for Ultiva sales, exclusivity, and generic risk

Executive summary: Ultiva (remifentanil) is a niche, hospital-controlled opioid analgesic with demand driven by perioperative anesthesia workflow, surgical volumes, and managed availability. Financial trajectory has historically tracked institutional purchasing cycles more than outpatient growth, with revenue concentrated in North America and Europe. The commercial risk profile is dominated by generic entry timing and competitive pricing pressure, while IP risk hinges on whether meaningful remifentanil-specific branded exclusivities or use/formulation patents remain enforceable in key markets. The near-term market outlook is typically steady to down-drifting if generic alternatives are widely listed on formularies and if procurement shifts favor lowest acquisition cost.

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How does ULTIVA (remifentanil) sell in hospitals and what drives demand?

Ultiva is remifentanil, a short-acting, ultra–rapid-onset opioid used for anesthesia induction and maintenance, and for analgesia during procedures under controlled dosing. Hospital demand is primarily procedural and supply-chain driven:

• Operating room throughput: utilization rises with elective and non-elective surgical volumes.
• Anesthesia protocols: remifentanil adoption depends on anesthesia regimen preferences and clinical pathways (TIVA vs volatile anesthesia strategies).
• Inventory management and pharmacy procurement: hospitals tend to standardize preferred opioids in surgical formularies, then rebid or re-contract.
• NADAs and GPO contracting cycles: price and volume follow group purchasing organization dynamics and tender schedules.
• Short shelf-life and cold-chain constraints (if applicable by product handling): procurement decisions can shift between brands and authorized generics based on availability.

Featured snippet answer: Ultiva demand is driven by perioperative surgical volumes and anesthesia protocol standardization, with revenue largely tied to hospital purchasing and contract cycles rather than outpatient prescription growth.

Where does remifentanil demand concentrate geographically?

• North America is typically the largest commercial remifentanil market due to high surgical volume and mature hospital contracting.
• Europe follows, with procurement fragmentation across countries but similar hospital-focused utilization mechanics.

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What is the financial trajectory for Ultiva revenue over time?

Ultiva’s financial pattern usually shows the following characteristics (directionally consistent with mature, hospital-only opioid brands exposed to generic pressure):

• Moderate peak followed by margin compression as lower-priced alternatives gain formulary share.
• Stability by volume early in generic ramp, then declining pricing as procurement favors lowest cost.
• Periodic revenue variability tied to contract wins/losses with large hospital systems and distribution changes.

Key dynamic: For remifentanil products, revenue changes tend to be pricing-led rather than utilization-led, because the underlying procedural demand is relatively inelastic.

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What Orange Book status applies to ULTIVA and what does it mean for generics?

For small-molecule injectable opioids, the generic risk turns on whether the branded product has:

• Approved ANDAs for multiple dosage forms/strengths, or
• Stated exclusivity protections still in force, and
• Patent estate listings in the FDA Orange Book for each listed NDC.

Featured snippet answer: Ultiva’s generic risk is determined by FDA Orange Book patent listings tied to the specific remifentanil dosage forms and by whether the Orange Book-listed patents have expired or are no longer enforceable in each strength/NDC.

How to read the Orange Book for ULTIVA (remifentanil) in litigation risk terms

• Patents listed for the branded NDCs create the legal trigger for paragraph IV challenges.
• If listed patents have expired or are not enforceable for the relevant generic filing, the generic can move toward approval and launch timing.
• If multiple patents cover different aspects (method of use, formulation, stability), the practical launch window depends on the last-to-expire enforceable patent.

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When does ULTIVA lose exclusivity and what are the expected generic launch scenarios?

Generic entry scenarios for Ultiva typically fall into two buckets:

1. Patent-expiration-driven launch

   • Generic approval can occur once the last relevant listed patent expires, with launch shortly after to capture the remaining brand share.

2. Paragraph IV settlement / delayed launch

   • If a generic files a paragraph IV and the parties settle, launch can shift based on settlement terms, including potential “no-cause” windows, royalties, or agreed entry dates.

Featured snippet answer: Ultiva’s exclusivity loss timeline is governed by the Orange Book “last-to-expire” patent across the NDCs for the branded dosage forms. Generic launch typically tracks the last-to-expire enforceable patent unless a settlement earlier limits or delays entry.

What typically determines whether a generic launches immediately

• Agreement terms in any settlement
• Whether FDA approves the generic with a “skinny label” that avoids patent-covered indications (if method-of-use patents are at issue)
• Manufacturing and supply readiness for the injectable product

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How many patents protect remifentanil (ULTIVA) and what types of patents matter?

Remifentanil brands commonly face a layered IP structure that can include:

• Composition of matter (drug substance level)
• Formulation and manufacturing method (stability, process, excipients, container closure)
• Method of use patents (anesthesia administration regimens, dosing, perioperative protocols)

Commercial implication: Even when composition patents are long expired, formulation and manufacturing method patents can still delay generic launches for specific NDC presentations.

Patent estate mapping approach for Ultiva decision-making

• Identify the Orange Book listed patents per strength/NDC
• Categorize them by:
  • method-of-use vs formulation vs manufacturing
• Determine:
  • expiration date by jurisdiction coverage (US filings)
  • whether patents are still asserted in litigation

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What patent litigation affects ULTIVA (remifentanil) and how can it change launch timing?

Patent litigation affecting mature injectable opioids generally affects launch timing through:

• preliminary injunctions (rare at later stages unless a strong infringement showing exists)
• settlement agreements that delay entry
• adjudicated non-infringement or invalidity

Featured snippet answer: Ultiva’s generic timeline is most impacted by whether any paragraph IV challenges led to settlements or active injunctions and by whether the last asserted Orange Book patent was upheld or expired.

What to watch in litigation outcomes

• Courts’ view on claim construction for dosing/regimen claims (if method-of-use is asserted)
• Validity findings that can accelerate subsequent filings
• Whether settlements cover all strengths or only specific NDCs

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Which companies supply remifentanil and how does competition affect pricing?

Hospital procurement usually intensifies when multiple suppliers are available with:

• consistent supply,
• acceptable vial/strength parity,
• and competitive contract pricing.

Competition typically results in:

• brand share erosion in standardized hospital formularies,
• price compression tied to rebids,
• rebates and contracting adjustments rather than product switching to less-preferred regimens.

Featured snippet answer: Remifentanil competition typically drives Ultiva revenue down through price compression and formulary substitution once generics or authorized equivalents become contract-eligible.

How competition shows up on invoices

• acquisition cost decreases
• shifting rebate structures
• reduced net revenue per unit despite stable procedure volumes

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How does ULTIVA compare with other perioperative opioids (fentanyl, sufentanil) on market dynamics?

Remifentanil differs from classic opioids used in the OR in kinetics and dosing control:

• remifentanil is ultra–short acting with rapid offset, supporting protocol flexibility.
• fentanyl and sufentanil have longer half-lives and different titration behaviors.

Market impact: Because the clinical workflow values controllability, remifentanil retains procedural use even under generic pricing pressure, but hospitals still seek lowest-cost remifentanil options once available.

Featured snippet answer: Ultiva competes mainly against alternative perioperative opioid choices in anesthesia protocol selection, but its biggest revenue threat is usually generic remifentanil pricing rather than substitution to other opioids.

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Is biosimilar risk relevant for ULTIVA?

No. Ultiva is a small-molecule injectable (remifentanil), so biosimilar pathways do not apply. The relevant generic risk is via ANDA and Orange Book patents.

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What formulation and manufacturing barriers exist for generic Ultiva injectables?

Injectable remifentanil products can face barriers that include:

• process controls for stability and degradation profile
• container closure system compatibility
• assurance of concentration accuracy and reconstitution behavior (where applicable)
• scaling validated manufacturing under cGMP

Featured snippet answer: Generic entry hinges on demonstrating stability, bioequivalence, and manufacturing reproducibility for the specific formulation and strength, not biologics-style complexity.

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Revenue exposure: which factors most change Ultiva net sales in the next 12–36 months?

1. Contracting and formulary status shifts
   • inclusion/exclusion in large hospital group formularies
2. Relative price positioning vs authorized generics
   • net price after rebates and procurement discounts
3. Supply stability
   • intermittent shortages can briefly lift net pricing power; normalization drives declines
4. Any Orange Book/patent litigation resolution
   • earlier-than-expected generic entry accelerates net revenue erosion

Featured snippet answer: The next-phase net sales trajectory is most sensitive to institutional contract rebids and the availability of lower-priced remifentanil equivalents.

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Key Takeaways

• Ultiva (remifentanil) is a hospital-driven, procedure-timed analgesic where demand is relatively inelastic, so revenue trajectory is usually pricing-led.
• Competitive pressure is typically dominated by generic remifentanil availability, contract eligibility, and formulary standardization, not biosimilar risk.
• The practical launch clock for generics is set by Orange Book patent listings and enforceability by NDC/strength, with paragraph IV challenges and settlements acting as timing shifters.
• Financial outcomes over time generally reflect a shift from brand premiums to net price compression as contract structures incorporate lower-cost alternatives.

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FAQs

What is Ultiva’s primary FDA regulatory pathway and what does it imply for generics?

Ultiva is supported by an FDA-approved NDA for remifentanil; generic products typically seek approval under ANDA with bioequivalence and certification against Orange Book patents.

Do method-of-use patents (dosing regimens) matter for generic remifentanil?

Yes, if method-of-use patents are listed for the branded NDCs, generic approval may be constrained by whether the generic label can be carved to avoid patented regimens.

How do hospital group purchasing organizations influence Ultiva pricing?

GPO contracting and rebid schedules can reset net pricing, shifting share toward suppliers with stronger contract pricing and supply reliability.

Can limited stock or supply disruptions temporarily change Ultiva revenues?

Yes. Shortages or supply constraints can raise effective acquisition pricing and increase fill rates for available suppliers until supply normalizes.

Is competition mostly substitution to other opioids or within-class remifentanil generics?

Primarily within-class, because hospitals standardize anesthesia agents by protocol and procurement; however, protocol preferences can influence the mix among remifentanil, fentanyl, and sufentanil.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. ANDA regulations and paragraph IV patent certification framework (21 U.S.C. §355 and implementing FDA guidance). U.S. Food and Drug Administration.