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Cytarabine Patent Expiration

Cytarabine is used for treating lymphomatous meningitis via intrathecal administration. It was first introduced by Teva Parenteral Medicines Inc in its drug Cytarabine on Approved Prior to Jan 1, 1982. Another drug containing Cytarabine is Depocyt. 11 different companies have introduced drugs containing Cytarabine.


Cytarabine Patents

Given below is the list of patents protecting Cytarabine, 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
Depocyt US5723147 Multivesicular liposomes having a biologically active substance encapsulated therein in the presence of a hydrochloride Mar 03, 2015

(Expired)

 Pacira Pharms Inc
Depocyt US5455044 Method for treating neurological disorders May 14, 2013

(Expired)

 Pacira Pharms Inc



Cytarabine's Family Patents

Family Patents

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Cytarabine Generic API Manufacturers

Several generic applications have been filed for Cytarabine. The first generic version for Cytarabine was by Hikma Pharmaceuticals Usa Inc and was approved on Aug 2, 1989. And the latest generic version is by Meitheal Pharmaceuticals Inc and was approved on Feb 28, 2022.

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


1. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Cytarabine. 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
100MG/ML

(reference standard)

injectable Prescription INJECTION AP Jan 15, 2004


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
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





2. GLAND PHARMA LTD

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL

injectable Prescription INJECTION AP Dec 23, 2019
2GM/VIAL

injectable Prescription INJECTION AP Dec 23, 2019





3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Cytarabine. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL

injectable Prescription INJECTION AP Aug 2, 1989
500MG/VIAL

(reference standard)

injectable Prescription INJECTION N/A Aug 2, 1989


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





4. HOSPIRA

Hospira Inc has filed for 2 different strengths of generic version for Cytarabine. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML

(reference standard)

injectable Prescription INJECTION AP Feb 28, 1994
100MG/ML

injectable Prescription INJECTION AP Nov 22, 1999


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Rocky Mount Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





5. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 2 different strengths of generic version for Cytarabine. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML

injectable Prescription INJECTION AP Feb 28, 2022
100MG/ML

injectable Prescription INJECTION AP Jul 17, 2018





6. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Cytarabine. 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
20MG/ML

injectable Discontinued INJECTION N/A Dec 13, 2011





7. RISING

Rising Pharma Holding Inc has filed for 2 different strengths of generic version for Cytarabine. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/ML

injectable Prescription INJECTION AP Dec 13, 2011
100MG/ML

injectable Prescription INJECTION AP Jan 30, 2012


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





8. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Cytarabine. All of these versions come by the name CYTOSAR-U. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2GM/VIAL

injectable Discontinued INJECTION N/A Dec 30, 1998
100MG/VIAL

injectable Discontinued INJECTION N/A Dec 30, 1998
500MG/VIAL

injectable Discontinued INJECTION N/A Dec 30, 1998
1GM/VIAL

injectable Discontinued INJECTION N/A Dec 30, 1998





9. WEST-WARD PHARMS INT

West-ward Pharmaceuticals International Ltd has filed for 2 different strengths of generic version for Cytarabine. Given below are the details of the strengths of this generic introduced by West-ward Pharms Int.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/VIAL

(reference standard)

injectable Prescription INJECTION N/A Aug 31, 1994
2GM/VIAL

(reference standard)

injectable Prescription INJECTION AP Aug 31, 1994