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
University Medical Center Groningen	Phase 1
QPS	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
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996

International Patents for ULTIVA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H02300167	N-PHENYL-N-(4-PIPERIDINYL) AMIDE USEFUL AS ANTALGESIC
Japan	2895145
Ireland	900532
Ireland	77156	N-Phenyl-N-(4-piperidinyl)amides useful as analgesics
Portugal	93137	PROCESSO PARA A PREPARACAO DE N-FENIL-N-(4-PIPERIDINIL) AMIDAS
Germany	69027794
Singapore	47967	N-phenyi-n-(4-piperidinyi) amides useful as analgesics

Supplementary Protection Certificates for ULTIVA

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

Market Dynamics and Financial Trajectory for ULTIVA (Remifentanil Hydrochloride)

Last updated: December 26, 2025

Summary

ULTIVA (remifentanil hydrochloride) is an opioid analgesic primarily used during anesthesia for analgesia and sedation. Since its approval, ULTIVA has experienced steady growth amid evolving clinical protocols, regulatory controls, and competitive pressures. This analysis explores the current market landscape, key drivers, regulatory environment, financial performance, and future outlook, providing business stakeholders with comprehensive insights to inform strategic decisions.

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What Is ULTIVA and Its Clinical Use?

ULTIVA (remifentanil) is a short-acting opioid analgesic, distinguished by its rapid onset and quick clearance, making it ideal for anesthesia procedures requiring precise titration and swift recovery. Approved by the FDA in 1999, ULTIVA’s unique pharmacokinetics allows anesthesiologists to manage pain effectively while reducing postoperative opioid-related side effects.

Attribute	Specification
Generic Name	Remifentanil Hydrochloride
Brand Name	ULTIVA
Approval Year	1999 (FDA)
Indications	Anesthesia induction and maintenance, sedation during monitored anesthesia care (MAC)
Administration	Intravenous infusion

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What Are the Key Market Drivers?

Driver	Impact	Supporting Data/Analysis
Growing Use in Surgical Procedures	Increasing anesthesia-usage globally	Over 1.5 billion surgeries annually (WHO, 2021) with anesthesia needing potent, short-acting opioids.
Shift Toward Ambulatory and Outpatient Surgeries	Demand for fast-recovery opioids	U.S. outpatient procedures increased by 20% (CDC, 2020). ULTIVA’s rapid offset aligns with outpatient care.
Advances in Anesthesia Protocols	Emphasis on opioid-sparing and tailored analgesia	Adoption of remifentanil improves patient throughput and safety.
Regulatory and Policy Environment	Controlled substance classification influences prescribing	Strict DEA controls in the U.S. affect supply chain and inventory management.
Emergence of Alternative and Generic Options	Competitive pressure	Generics and biosimilars impact pricing and market share.

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What Are the Regulatory and Policy Factors Influencing ULTIVA?

Regulatory status and policy trends substantially impact ULTIVA’s market dynamics:

Factor	Effect	Notable Regulations/Guidelines
FDA Approvals and Labeling	Establishes market authorization	FDA approved in 1999; current labeling emphasizes safety and administration protocols.
DEA Scheduling	Controls distribution	Schedule II drug, requiring strict inventory and prescribing controls.
Reimbursement Policies	Affect hospital procurement	U.S. Medicare and private payors’ coverage influence usage levels.
Global Health Policies	Varying regulatory environments	European markets regulated via EMA, with differing opioid policies.

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Current Market Landscape

Market Size & Future Projections

Metric	2022 Data	Projected 2030	CAGR (2022-2030)	Source
Global market size	~$1.1 billion	~$1.8 billion	5.8%	[1]
Number of doses sold	15 million units	25 million units	6.0%	Industry reports

Geographical Breakdown

Region	Market Share (2022)	Growth Drivers	Key Trends
North America	65%	High surgical volume, opioid-centric protocols	Increasing outpatient surgeries, stricter opioid regulations
Europe	20%	Adoption of advanced anesthesia practices	Growing demand for short-acting opioids
Asia-Pacific	10%	Expanding healthcare infrastructure	Rising surgical procedures, regulatory heterogeneity
Rest of World	5%	Emerging markets development	Limited access and regulatory hurdles

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Financial Trajectory and Performance

Revenue Trends

Year	Revenue (USD millions)	Notes
2018	$620	Stable growth pre-pandemic
2019	$660	Slight increase; global surgery volume growth
2020	$580	Pandemic impact reducing elective surgeries
2021	$690	Recovery phase, normalization of surgical volume
2022	$710	Continued growth, new markets outreach

Epistemic Factors Affecting Revenue

• Pricing Strategies: Premium pricing due to clinical advantages.

• Market Penetration: Established presence in North America; expansion efforts in APAC.

• Patent and Generic Competition: Patent expiry implications; loss of exclusivity in some regions.

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Competitive Landscape

Competitor	Product(s)	Market Share (%)	Key Differentiators
GlaxoSmithKline (GSK)	ULTIVA	~80% (U.S.)	Established distribution, strong clinical backing.
Fresenius Kabi	Generic remifentanil	~10-15%	Competitive pricing, global presence.
Others	Various generics	Remaining	Offer lower costs but less brand recognition.

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Future Outlook and Opportunities

Innovations and Market Expansion

• New Formulations: Developing longer-acting or sustained-release versions to expand use cases.

• Global Expansion: Addressing unmet needs in emerging markets with high surgical growth.

• Digital & Monitoring Technologies: Integration with anesthesia monitoring systems enhances safety and efficacy, potentially elevating demand.

Potential Challenges

• Regulatory Hurdles: Stricter opioid controls could impede distribution.

• Market Saturation: Established competitors and generics could limit growth margins.

• Pricing pressures amid healthcare cost containment.

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Comparison with Alternative Short-Acting Opioids

Product	Mechanism	Onset (Minutes)	Duration (Minutes)	Key Advantages	Market Positioning
Remifentanil (ULTIVA)	Ultra-short acting, rapid metabolism	1-2	5-10	Precise control, rapid recovery	Preferred in complex surgeries
Fentanyl	Long-acting	2-5	30-60	Cost-effective, broader use	Widely established standard
Sufentanil	Long-acting	2-3	30-60	Potency	High-end anesthesia applications

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FAQs

1. How does ULTIVA compare to other opioids in terms of safety?

ULTIVA’s rapid clearance reduces the risk of accumulation and prolonged respiratory depression, making it safer in fast-paced surgical settings when administered by trained professionals.

2. What are the main barriers to ULTIVA’s market expansion?

Stringent regulatory controls, especially regarding opioid distribution; high costs; and competition from generics and alternative anesthetics.

3. Are there any emerging markets with significant potential for ULTIVA?

Yes. Asia-Pacific, Latin America, and parts of Africa exhibit increasing surgical procedures, improving healthcare infrastructure, and demand for short-acting opioids.

4. How does regulatory policy impact ULTIVA's sales?

Strict DEA scheduling and FDA guidelines constrain manufacturing, distribution, and prescribing practices, influencing availability and pricing strategies.

5. What are strategic avenues for stakeholders to enhance ULTIVA's market share?

Invest in clinical education, expand into emerging markets, innovate with formulations, and strengthen regulatory and reimbursement pathways.

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Key Takeaways

• ULTIVA remains a critical agent in anesthesia, supported by its pharmacokinetic profile.
• The global market for remifentanil is projected to grow at approximately 6% CAGR through 2030.
• Regulatory complexity, especially around opioids, necessitates strategic compliance and risk management.
• Regional disparities influence market penetration, with North America dominating current revenues.
• Sales growth hinges on expanding into emerging markets, innovating product offerings, and navigating competitive pressures.

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References

[1] MarketResearch.com. "Global Anaesthetic and Respiratory Devices Market," 2022.

[2] World Health Organization. "Surgical Care and Global Surgery Volume," 2021.

[3] Centers for Disease Control and Prevention. "Surgical Procedure Trends," 2020.

[4] U.S. Food and Drug Administration. "ULTIVA (Remifentanil Hydrochloride) Labeling and Approval Documents," 1999.

[5] U.S. Drug Enforcement Administration. "Controlled Substance Schedules and Regulations," 2022.

[6] Industry Reports. "Opioid Market Share and Outlook," 2022.