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:	45
Clinical Trials:	98
Patent Applications:	4,775
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
Paion UK Ltd.	Phase 1
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	020630-002	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	020630-003	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

International Patents for ULTIVA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2088961
Canada	2010011	N-PHENYL-N-(4-PIPERIDINYL) AMIDES UTILES COMME ANALGESIQUES (N-PHENYL-N-(4-PIPERIDINYL) AMIDES USEFUL AS ANALGESICS)
Japan	H02300167	N-PHENYL-N-(4-PIPERIDINYL) AMIDE USEFUL AS ANTALGESIC
Mexico	9203024	N-FENIL-N-(4-PIPERIDINIL)AMIDAS Y COMPOSICIONES FARMACEUTICAS QUE LAS CONTIENEN.
Ireland	77156	N-Phenyl-N-(4-piperidinyl)amides useful as analgesics
Austria	140451

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	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	SZ 34/1996	Austria		PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID
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

ULTIVA Market Analysis and Financial Projection Experimental

Ultiva (Remifentanil Hydrochloride for Injection): Market Dynamics and Financial Trajectory

Introduction

Ultiva, known chemically as Remifentanil Hydrochloride for Injection, is a potent, short-acting synthetic opioid analgesic drug. It is widely used in clinical settings for anesthesia and pain management. Here, we delve into the market dynamics and financial trajectory of Ultiva, highlighting key trends, drivers, and projections.

Market Size and Growth

The global Remifentanil Hydrochloride for Injection market has been experiencing significant growth. As of 2022, the market size was valued at US$ 414 million. Projections indicate that this market is expected to reach US$ 752.2 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 8.9% during the forecast period from 2023 to 2029[4].

Key Drivers

Several factors are driving the growth of the Ultiva market:

Increasing Demand for Anesthesia

The rising number of surgical procedures globally is a significant driver. As the population ages and chronic illnesses increase, the need for surgical interventions, and consequently for anesthesia, also rises. This trend is particularly pronounced in regions like North America and Europe, where there is a high prevalence of surgical procedures[3].

Technological Advancements

Advancements in anesthetic technology and the adoption of ambulatory anesthesia are also boosting the market. Ambulatory anesthesia allows patients to recover quickly and leave the hospital sooner, which is beneficial for both patients and healthcare providers[3].

Regulatory Approvals

Recent approvals for general anesthetic drugs, such as the FDA approval of Propofol injectable anesthetic emulsion in 2020, have supported market growth. Such approvals enhance the availability and accessibility of effective anesthetic medications[3].

Market Segmentation

The market for Remifentanil Hydrochloride for Injection can be segmented in several ways:

By Type

The market can be segmented based on the type of formulation, such as injectable solutions and others.

By Application

Ultiva is primarily used in surgical settings for general anesthesia and in intensive care units for pain management. The pain relief segment, particularly in post-surgical care, holds a significant market share[1].

By Region

North America, followed by Europe, dominates the market due to robust healthcare infrastructure and a high number of surgical procedures. Asia-Pacific is expected to grow at a rapid pace due to increasing healthcare spending and a rising number of surgeries[1][3].

Financial Performance

The financial performance of the Ultiva market is robust, driven by increasing demand and technological advancements.

Revenue Growth

The market is expected to more than double from US$ 414 million in 2022 to US$ 752.2 million by 2029, indicating a strong revenue growth trajectory[4].

Competitive Landscape

Key players in the market include Jiangsu Nhua Pharmaceutical, Yichang Renfu Pharmaceutical, Sinopharm Group, Aspen, Fresenius Kabi, and Sandoz. These companies are investing heavily in research and development to improve formulations and expand their market share[4].

Challenges and Limitations

Despite the positive growth trajectory, the market faces several challenges:

Regulatory Scrutiny

Opioid medications, including Ultiva, are under strict regulatory scrutiny due to the opioid epidemic. This scrutiny can impact the market by imposing stricter prescribing and dispensing guidelines[1].

Cost and Accessibility

The expensive nature of procedures and branded medications can limit market growth, especially in low-income countries and distant locations where access to healthcare services is limited[3].

Physician and Nurse Shortage

A scarcity of anesthetic physicians and certified anesthetic nurses per capita population can also hinder the growth of the general anesthesia drugs market, including Ultiva[3].

Future Outlook

The future outlook for Ultiva is promising, driven by several factors:

Increasing Surgical Procedures

The rising number of surgical procedures, especially in aging populations, will continue to drive the demand for effective anesthesia solutions like Ultiva[3].

Technological Innovations

Continued innovations in anesthetic technology and the adoption of ambulatory anesthesia will enhance patient outcomes and reduce recovery times, further boosting the market[3].

Regulatory Support

Ongoing regulatory approvals and initiatives to improve access to opioid overdose treatments, such as the FDA approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray, will support the safe and responsible use of opioids like Ultiva[1].

Key Takeaways

• The global Remifentanil Hydrochloride for Injection market is expected to grow significantly, reaching US$ 752.2 million by 2029.
• Key drivers include increasing demand for anesthesia, technological advancements, and regulatory approvals.
• The market is segmented by type, application, and region, with North America and Europe being the dominant regions.
• Despite challenges such as regulatory scrutiny and cost barriers, the future outlook remains positive due to rising surgical procedures and technological innovations.

FAQs

Q: What is the current market size of Remifentanil Hydrochloride for Injection? A: As of 2022, the market size was valued at US$ 414 million[4].

Q: What is the projected growth rate of the Remifentanil Hydrochloride for Injection market? A: The market is expected to grow at a CAGR of 8.9% from 2023 to 2029[4].

Q: Which regions dominate the Remifentanil Hydrochloride for Injection market? A: North America and Europe are the dominant regions, driven by robust healthcare infrastructure and a high number of surgical procedures[1][3].

Q: What are the main challenges facing the Remifentanil Hydrochloride for Injection market? A: Regulatory scrutiny, cost barriers, and a scarcity of anesthetic physicians and nurses are significant challenges[1][3].

Q: Who are the key players in the Remifentanil Hydrochloride for Injection market? A: Key players include Jiangsu Nhua Pharmaceutical, Yichang Renfu Pharmaceutical, Sinopharm Group, Aspen, Fresenius Kabi, and Sandoz[4].

Sources

1. Biospace: Opioids Market Size to Worth Around USD 26.78 Billion by 2034
2. Ultralife Corporation: Ultralife Corporation Reports Second Quarter Results
3. Future Market Insights: General Anesthesia Drugs Market Size, Trends - 2033
4. Valuates Reports: Remifentanil Hydrochloride for Injection Market Size