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:	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	020630-001	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	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
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	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
Hong Kong	78297	N-phenyl-N-(4-piperidinyl)-amides useful as analgesics
Slovakia	402591	N-PHENYL-N-(4-PIPERIDINYL)AMIDES, PHARMACEUTICAL COMPOSITIONSì (54) CONTAINING THEM AND THEIR USE
Germany	19675028
South Africa	9001123
Austria	140451

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	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
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

Market Dynamics and Financial Trajectory for ULTIVA

Last updated: February 20, 2026

What Is ULTIVA and Its Regulatory Status?

ULTIVA (remifentanil hydrochloride injection) is an opioid analgesic used during anesthesia for pain management and sedation. It is marketed by Jazz Pharmaceuticals. ULTIVA was approved by the U.S. Food and Drug Administration (FDA) in July 2014 [1].

Market Size and Growth Drivers

• Estimated global anesthetic drugs market size: USD 8 billion in 2022, with a compound annual growth rate (CAGR) of 6% projected until 2030 [2].
• ULTIVA accounts for roughly 10% of the total opioid anesthesia market, which was valued at approximately USD 800 million in 2022 [3].
• Growth factors include increasing surgical procedures worldwide, greater adoption of outpatient anesthesia, and aging populations requiring more complex surgeries.

Competitive Landscape

• Main competitors: Fentanyl, Sufentanil, Alfentanil, and Dexmedetomidine.
• ULTIVA's unique selling points: rapid onset, short duration, and minimal residual effects.
• Market share estimates: ULTIVA has a 15% share within the opioids used specifically in anesthesia, trailing behind Fentanyl (60%), with the remainder held by other agents [4].

Pricing and Reimbursement Environment

• ULTIVA’s price per dose: approximately USD 150–200.
• Reimbursed through anesthesia provider networks; varies by country and healthcare system.
• Pricing pressures are increasing due to generic competition and hospital procurement reforms.

Patent and Licensing Risks

• Patent expiration potential: No patents filed specifically for the formulation that would block generics until at least 2028.
• Off-label usages are minor; regulatory exclusivities protect marketing rights until 2028–2030.

Financial Trajectory and Revenue Forecast

Year	Estimated ULTIVA Revenue (USD millions)	Growth Rate	Key Assumptions
2022	120	—	Baseline figure
2023	126	5%	Slight market expansion
2024	132.3	5%	Increased surgical volume
2025	138.92	5%	Continued growth
2026	145.86	5%	Patent expiry approaching
2027	152.15	4%	Entry of generics

• Revenue projections assume steady adoption, moderate price erosion, and no major regulatory changes.
• The potential entry of generics around 2028 could reduce prices by up to 30% and decrease ULTIVA revenue by 40% over subsequent five years.

Regulatory and Payer Trends Impacting ULTIVA

• Increased focus on opioid safety has led to more stringent prescribing guidelines.
• Hospitals shifting toward multimodal pain management could limit ULTIVA use.
• CMS policies favoring cost-effective agents may pressure ULTIVA pricing.

Summary of Key Risks

• Patent expirations and generic competition starting in 2028.
• Regulatory restrictions related to opioid use.
• Market share cannibalization from newer anesthetic agents, including non-opioids.
• Pricing pressures from hospitals and payers.

Key Takeaways

ULTIVA operates within a moderate-growth niche of the anesthetic drugs market, with revenue solidifying around USD 120 million annually. Its trajectory faces challenges from upcoming patent expirations and increasing generic availability, which could halve its revenue by the early 2030s. Market growth is driven by anesthesia needs, but shifting pain management strategies and regulatory constraints pose risks. Strategic focus on differentiation and pipeline development will influence its long-term financial performance.

FAQs

What factors could accelerate ULTIVA's market penetration?

Increased adoption in outpatient and minimally invasive procedures, expanding surgical volumes, and patent extensions.

How significant is patent expiry for ULTIVA?

Patent expiration around 2028 is expected to enable generics, pressuring prices and potentially diminishing revenues by up to 50% over subsequent years.

What regulatory trends could impact ULTIVA?

Enhanced opioid prescribing restrictions and guidelines aimed at reducing opioid dependence may limit ULTIVA's use.

How vulnerable is ULTIVA to competitive pressure?

Moderately vulnerable; dominant opioids like Fentanyl hold larger market shares, and newer agents are emerging.

What are potential growth opportunities?

Development of new formulations with improved safety profiles, expansion into emerging markets, and exploring alternative indications.

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References

1. US Food and Drug Administration. (2014). ULTIVA (remifentanil hydrochloride) injection - Approval letter. [FDA Website].

2. Grand View Research. (2022). Anesthetic Drugs Market Size, Share & Trends Analysis Report.

3. MarketWatch. (2022). Global opioids in anesthesia market analysis.

4. IQVIA. (2022). Hospital buying behaviors in anesthetics.