Remifentanil Hydrochloride Patent Expiration

Remifentanil Hydrochloride was first introduced by Mylan Institutional Llc in its drug Ultiva on Jul 12, 1996. 4 different companies have introduced drugs containing Remifentanil Hydrochloride.


Remifentanil Hydrochloride Patents

Given below is the list of patents protecting Remifentanil Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ultiva US5866591

(Pediatric)

Stable formulations of remifentanil Mar 10, 2018

(Expired)

Mylan Institutional
Ultiva US5866591 Stable formulations of remifentanil Sep 10, 2017

(Expired)

Mylan Institutional



Remifentanil Hydrochloride's Family Patents

Family Patents

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Remifentanil Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Remifentanil Hydrochloride. The first generic version for Remifentanil Hydrochloride was by Fresenius Kabi Usa Llc and was approved on Jan 16, 2018. And the latest generic version is by Nivagen Pharmaceuticals Inc and was approved on Jun 28, 2024.

Given below is the list of companies who have filed for Remifentanil Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Remifentanil Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/VIAL

injectable Prescription INJECTION AP Jan 16, 2018
EQ 2MG BASE/VIAL

injectable Prescription INJECTION AP Jan 16, 2018
EQ 5MG BASE/VIAL

injectable Prescription INJECTION AP Jan 16, 2018


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA LLC
Skokie Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC





2. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Remifentanil Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/VIAL

injectable Prescription INJECTION AP Oct 13, 2020
EQ 2MG BASE/VIAL

injectable Prescription INJECTION AP Oct 13, 2020
EQ 5MG BASE/VIAL

injectable Prescription INJECTION AP Oct 13, 2020


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





3. NIVAGEN PHARMS INC

Nivagen Pharmaceuticals Inc has filed for 3 different strengths of generic version for Remifentanil Hydrochloride. Given below are the details of the strengths of this generic introduced by Nivagen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/VIAL

injectable Prescription INJECTION AP Jun 28, 2024
EQ 2MG BASE/VIAL

injectable Prescription INJECTION AP Jun 28, 2024
EQ 5MG BASE/VIAL

injectable Prescription INJECTION AP Jun 28, 2024