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Levoleucovorin Calcium Patent Expiration

Levoleucovorin Calcium was first introduced by Acrotech Biopharma Inc in its drug Fusilev on Mar 7, 2008. Another drug containing Levoleucovorin Calcium is Levoleucovorin Calcium. 11 different companies have introduced drugs containing Levoleucovorin Calcium.


Levoleucovorin Calcium Patents

Given below is the list of patents protecting Levoleucovorin Calcium, 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
Fusilev US6500829 Substantially pure diastereoisomers of tetrahydrofolate derivatives Mar 07, 2022

(Expired)

 Acrotech Biopharma



Levoleucovorin Calcium's Family Patents

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Levoleucovorin Calcium Generic API Manufacturers

Several generic applications have been filed for Levoleucovorin Calcium. The first generic version for Levoleucovorin Calcium was by Sandoz Inc and was approved on Mar 9, 2015. And the latest generic version is by Hainan Poly Pharmaceutical Co Ltd and was approved on May 22, 2023.

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


1. ACTAVIS LLC

Actavis Llc has filed for 1 generic for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Actavis Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

powder Discontinued INTRAVENOUS N/A Feb 13, 2017


Manufacturing Plant Locations
New

Actavis Llc'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 Actavis Llc as present at those locations.

Country City Firm Name
United States
Edison Actavis LLC





2. AMNEAL

Amneal Eu Ltd has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/VIAL

powder Discontinued INTRAVENOUS N/A Feb 13, 2017
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Prescription INTRAVENOUS AP Sep 8, 2017


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Paterson Amneal Pharmaceuticals, Llc
Hauppauge Amneal Pharmaceuticals of New York, LLC
Piscataway Amneal Pharmaceuticals, LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





3. GLAND

Gland Pharma Ltd has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

(reference standard)

solution Prescription INTRAVENOUS AP Sep 14, 2018
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Prescription INTRAVENOUS AP Sep 14, 2018


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Sriperumbudur Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited





4. HAINAN POLY PHARM

Hainan Poly Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Hainan Poly Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Prescription INTRAVENOUS AP May 22, 2023
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

solution Prescription INTRAVENOUS AP May 22, 2023


Manufacturing Plant Locations
New

Hainan Poly Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Hainan Poly Pharm as present at those locations.

Country City Firm Name
China
Haikou Hainan Poly Pharm. Co., Ltd.





5. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Levoleucovorin Calcium. 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 50MG BASE/VIAL

powder Discontinued INTRAVENOUS N/A Jun 16, 2016


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





6. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

(reference standard)

solution Prescription INTRAVENOUS AP Aug 16, 2019
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A Aug 16, 2019
EQ 50MG BASE/VIAL

powder Discontinued INTRAVENOUS N/A Aug 22, 2019





7. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A Oct 20, 2015
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A Oct 20, 2015





8. NOVAST LABS

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A May 3, 2018
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A May 3, 2018





9. PRAXGEN

Praxgen Pharmaceuticals Llc has filed for 1 generic for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Praxgen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A Nov 2, 2021


Manufacturing Plant Locations
New

Praxgen'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 Praxgen as present at those locations.

Country City Firm Name
United States
Monmouth Junction Praxgen Pharmaceuticals, LLC





10. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Levoleucovorin Calcium. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

solution Prescription INTRAVENOUS AP Mar 9, 2015
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

solution Discontinued INTRAVENOUS N/A Mar 9, 2015


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited