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. Four 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:	4,492
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
Paion UK Ltd.	Phase 1
University Medical Center Groningen	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

Expired US Patents for ULTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,019,583*PED
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	5,019,583*PED
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,466,700*PED

International Patents for ULTIVA

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	2002	N-Phenyl-N-(4-piperidinyl) amides useful as analgesics
Luxembourg	90011
South Africa	9001123

Supplementary Protection Certificates for ULTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SZ 34/1996	Austria		PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID

Market Dynamics and Financial Trajectory for ULTIVA (Remifentanil)

Last updated: July 28, 2025

Introduction

ULTIVA (remifentanil hydrochloride) is a short-acting synthetic opioid analgesic used extensively in anesthesia and critical care settings. Since its approval, ULTIVA has become a vital component in surgical procedures requiring rapid onset and offset of analgesia. Understanding its market dynamics involves analyzing competitive landscape, regulatory environment, healthcare policies, and emerging therapeutic protocols. Financial trajectory predictions hinge on sales performance, patent status, regional adoption, and potential generic competition.

Market Overview

Therapeutic Significance and Clinical Applications

Remifentanil's unique pharmacokinetic profile — characterized by rapid onset and clearance — renders it indispensable in anesthetic regimens. It offers precise titratability, minimal accumulation, and short duration of action, making it preferable for procedures like outpatient surgeries, cardiac anesthesia, and ICU sedation (1). Its role in enhanced recovery protocols bolsters demand, especially amidst a growing global surgical volume.

Regulatory Status and Market Access

ULTIVA received FDA approval in 1996 and European Medicines Agency (EMA) approval shortly thereafter. Its widespread acceptance owes partly to rigorous clinical data establishing efficacy and safety. Market access is further shaped by regional approvals, reimbursement policies, and hospital procurement protocols (2). However, regulatory scrutiny concerning opioid use influences prescribing trends and market expansion.

Competitive Landscape

ULTIVA operates in a competitive environment comprising patented formulations and generic versions. Its primary competitors include fentanyl and other ultra-short-acting opioids such as sufentanil. The expiration of remifentanil patents in some regions opens avenues for generic manufacturers, affecting pricing strategies and market share (3). Additionally, alternative anesthesia adjuncts and evolving pain management protocols influence its demand.

Market Dynamics

Demand Drivers

• Growing Surgical Volume: An expanding global aging population and increasing prevalence of chronic diseases augment the number of surgeries, elevating ULTIVA consumption.
• Shift Toward Rapid Recovery Protocols: The move toward outpatient and minimally invasive surgeries necessitates fast-acting anesthetics like ULTIVA.
• ICU Sedation Protocols: Critical care settings favor remifentanil owing to its rapid titratability, supporting sustained demand in intensive care units.

Supply Chain Challenges

Manufacturing complexities associated with remifentanil's synthesis, combined with stringent quality controls, influence supply consistency. Shortages, though rare, impact hospital procurement plans (4). Additionally, geopolitical factors and regulatory compliance costs affect production and distribution logistics.

Pricing and Reimbursement Trends

Pricing strategies for ULTIVA are influenced by patent status, competition from generics, and regional healthcare policies. In markets with high healthcare expenditure, generous reimbursements sustain margins, whereas cost-containment measures pressure pricing in emerging economies. The increasing emphasis on value-based care shifts focus toward cost-efficient use of anesthetics (5).

Regulatory and Legal Factors

Opioid regulation significantly affects ULTIVA’s market trajectory. Stringent controls aimed at curbing misuse and diversion introduce hurdles in procurement, prescribing, and distribution. Clear labeling and compliance with national narcotics legislation are critical for market continuity. Recent efforts to develop abuse-deterrent formulations may influence formulations' availability and acceptance.

Emerging Trends and Innovations

Advances in multimodal analgesia and alternative sedation options threaten to reduce reliance on opioids. Nanotechnology-based delivery systems and novel receptor targets are under investigation, potentially challenging ULTIVA's dominance in specific niches (6).

Financial Trajectory

Revenue Projections

The global market for remifentanil was valued at approximately USD 250 million in 2022, with expected compounded annual growth rates (CAGR) of around 4.5% over the next five years (7). North America remains the largest segment, owing to surgical volume and healthcare infrastructure, followed by Europe and Asia-Pacific.

Impact of Patent Expiration and Generics

Patent expiry and subsequent entry of generic remifentanil formulations could lead to price erosion and increased consumption volume, potentially stabilizing overall revenues while reducing profit margins for original innovators. Companies leveraging proprietary delivery devices and formulations could mitigate generic competition effects.

Market Expansion Strategies

Manufacturers focus on expanding into emerging markets by navigating regulatory pathways, establishing local manufacturing, and forming strategic alliances. Educational initiatives aimed at anesthesiologists and intensivists aim to reinforce ULTIVA’s clinical value proposition.

R&D and Pipeline Developments

Investments in improving remifentanil derivatives, formulations with extended release, or combination therapies could open new revenue avenues. However, high R&D costs and regulatory hurdles pose significant impediments, with many projects facing lengthy approval timelines.

Regional Market Perspectives

North America

Dominant due to high surgical volume and advanced healthcare infrastructure, North America's market benefits from established reimbursement schemes. However, evolving opioid policies and public scrutiny influence prescribing patterns.

Europe

European markets demonstrate steady growth, driven by aging populations and surgical advancements. Regulatory harmonization efforts facilitate market access but stringent narcotics legislation requires careful compliance.

Asia-Pacific

Emerging as a high-growth zone owing to expanding healthcare systems, rising surgical procedures, and increasing medical tourism. Challenges include regulatory complexities and price-sensitive markets, prompting manufacturers to adapt strategies accordingly.

Latin America and Middle East

Moderate growth expected, constrained by healthcare infrastructure disparities. Market penetration strategies focus on cost-effective formulations and collaborations with regional distributors.

Key Challenges and Opportunities

Challenges

• Regulatory Constraints: Stringent opioid control laws limit prescribing flexibility and patient access.
• Generic Competition: Price erosion from generics impacts revenues.
• Evolving Clinical Guidelines: Emphasis on opioid-sparing techniques may reduce usage.
• Supply Chain Disruptions: Manufacturing complexities and geopolitical tensions threaten consistent supply.

Opportunities

• Emerging Markets: Expansion in Asia-Pacific and Latin America presents growth potential.
• Innovation in Formulation: Extended-release or combination products could redefine usage paradigms.
• Education and Advocacy: Initiatives fostering awareness of remifentanil's clinical advantages can sustain demand.
• Alternative Indications: Exploration of analgesic roles outside anesthesia, such as in pain management, could diversify revenue streams.

Conclusion

ULTIVA’s market trajectory is shaped by inherent clinical advantages, regulatory architectures, competitive dynamics, and emerging healthcare trends. Its demand remains resilient within anesthetic and ICU domains, though facing headwinds from generic competition, policy shifts, and evolving clinical practices. Strategic positioning—through innovation, market expansion, and compliance—will determine its financial performance in a rapidly evolving landscape.

Key Takeaways

• Clinical Value Locks in Adoption: ULTIVA's pharmacokinetic profile sustains its enduring role in anesthesia and critical care.
• Patent Expirations and Generics Influence Revenue: The entry of generic formulations is likely to moderate growth but expand market volume.
• Regional Strategies Are Crucial: Tailored approaches leveraging regional healthcare policies and reimbursement landscapes optimize market penetration.
• Regulatory Environment Requires Vigilance: Navigating opioid regulations and compliance is essential for sustained market access.
• Innovation and Diversification Offer Growth: Expanding into new formulations and indications can mitigate competitive pressures and unlock new revenue streams.

FAQs

1. How does patent expiry affect ULTIVA’s market share?
Patent expiry enables generic manufacturers to produce cost-effective alternatives, increasing market competition and potentially decreasing prices, which can erode traditional market share for brand-name ULTIVA but also expand overall consumption.

2. What regional factors most influence ULTIVA’s adoption?
Healthcare infrastructure, regulatory policies concerning opioids, reimbursement schemes, and surgical volume are critical regional factors impacting adoption rates.

3. Can alternative analgesics replace ULTIVA in clinical practice?
While alternatives like fentanyl and non-opioid agents exist, ULTIVA’s rapid onset and offset continue to make it preferable in specific settings; however, evolving guidelines favor opioid-sparing approaches that may limit its use.

4. What are the primary challenges facing ULTIVA’s manufacturers?
Regulatory restrictions on opioids, patent expiration leading to generics, supply chain complexities, and evolving clinical guidelines pose significant challenges.

5. What innovations might shape ULTIVA’s future?
Development of long-acting formulations, combination therapies, and non-opioid analgesic alternatives could redefine its role and market size.

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References

1. Davis, T. et al. (2019). Pharmacokinetics of Remifentanil: Clinical Implications. Anesthesia & Analgesia, 128(3), 589–597.
2. European Medicines Agency. (2022). Summary of Product Characteristics for ULTIVA.
3. Johnson, M., & Taylor, D. (2020). The Impact of Patent Expiration on Opioid Market Dynamics. PharmacoEconomics, 38(4), 457–468.
4. WHO. (2021). Global Supply Chain Challenges for Controlled Substances. Medicines Transparency Alliance.
5. Healthcare Financial Management Association. (2021). Value-Based Care and Anesthetic Cost Management. HFMA Insights.
6. Lee, H., & Kim, S. (2022). Emerging Technologies in Pain Management. Pain Medicine, 23(1), 30–45.
7. MarketWatch. (2022). Remifentanil Market Size and Forecast.