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:	35
Clinical Trials:	98
Patent Applications:	5,119
Formulation / Manufacturing:	see details
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
University Medical Center Groningen	Phase 1
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

Anatomical Therapeutic Chemical (ATC) Classes for ULTIVA

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

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	020630-003	Jul 12, 1996

International Patents for ULTIVA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	78297	N-phenyl-N-(4-piperidinyl)-amides useful as analgesics
Spain	2088961
New Zealand	232542	N-PHENYL-N-(4-PIPERIDINYL)AMIDE DERIVATIVES; PREPARATORY PROCESSES AND PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for ULTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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