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Last Updated: October 23, 2020

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ULTIVA Drug Profile

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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. Two suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.

Drug patent expirations by year for ULTIVA
Drug Prices for ULTIVA

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Recent Clinical Trials for ULTIVA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Helse FonnaPhase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCSPhase 2
University Hospital, AkershusPhase 4

See all ULTIVA clinical trials

Pharmacology for ULTIVA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ULTIVA
Tradename Dosage Ingredient NDA Submissiondate
ULTIVA INJECTABLE;INJECTION remifentanil hydrochloride 020630 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   Start Trial   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 AP RX Yes No   Start Trial   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-003 Jul 12, 1996 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-003 Jul 12, 1996   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-001 Jul 12, 1996   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-003 Jul 12, 1996   Start Trial   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-001 Jul 12, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ULTIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0383579 SZ 34/1996 Austria   Start Trial PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID
0383579 C960030 Netherlands   Start Trial 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 19675028 Germany   Start Trial 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   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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