Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Moodys
McKesson
Colorcon
Mallinckrodt

Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020630

See Plans and Pricing

« Back to Dashboard

NDA 020630 describes ULTIVA, which is a drug marketed by Mylan Institutional and is included in one NDA. It is available from one supplier. Additional details are available on the ULTIVA profile page.

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.
Summary for 020630
Tradename:ULTIVA
Applicant:Mylan Institutional
Ingredient:remifentanil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020630
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 020630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630 NDA Mylan Institutional LLC 67457-198 67457-198-03 10 VIAL, GLASS in 1 CARTON (67457-198-03) > 3 mL in 1 VIAL, GLASS (67457-198-00)
ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630 NDA Mylan Institutional LLC 67457-198 67457-198-05 10 VIAL, GLASS in 1 CARTON (67457-198-05) > 5 mL in 1 VIAL, GLASS (67457-198-99)
Paragraph IV (Patent) Challenges for 020630
Tradename Dosage Ingredient NDA Submissiondate
ULTIVA INJECTABLE;INJECTION remifentanil hydrochloride 020630 2013-12-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/VIAL
Approval Date:Jul 12, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/VIAL
Approval Date:Jul 12, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/VIAL
Approval Date:Jul 12, 1996TE:APRLD:Yes

Expired US Patents for NDA 020630

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKesson
AstraZeneca
Express Scripts
Boehringer Ingelheim
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.