Thiotepa was first introduced by Immunex Corp in its drug Thiotepa on Approved Prior to Jan 1, 1982. Other drugs containing Thiotepa are Tepylute, Tepadina, Thioplex. 14 different companies have introduced drugs containing Thiotepa.
Thiotepa Patents
Given below is the list of patents protecting Thiotepa, along
with the drug name that holds that patent and the company name owning that
drug.
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Thiotepa Generic API Manufacturers
Several generic applications have been filed for Thiotepa. The first generic version for Thiotepa was by West-Ward Pharmaceuticals International Ltd and was approved on Apr 2, 2001. And the latest generic version is by Beloteca Inc and was approved on Aug 20, 2024.
Given below is the list of companies who have filed for
Thiotepa generic, along with the locations of their manufacturing plants worldwide.
1. BELOTECA
Beloteca Inc has filed for 1 generic for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Beloteca.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Aug 20, 2024
2. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Dr Reddys.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
injectable
Prescription
INJECTION
AP
May 4, 2018
3. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Thiotepa. 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
15MG/VIAL
injectable
Discontinued
INJECTION
N/A
Sep 20, 2001
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
4. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 2 different strengths of generic version for Thiotepa. 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
15MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Mar 8, 2021
100MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Jan 3, 2022
5. HENGRUI PHARMA
Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 1 generic for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Hengrui Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
injectable
Prescription
INJECTION
AP
May 4, 2018
6. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Thiotepa. 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
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Sep 5, 2023
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
7. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 2 different strengths of generic version for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Meitheal.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Dec 26, 2023
100MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Dec 26, 2023
8. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Msn.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Mar 4, 2020
100MG/VIAL
powder
Prescription
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
AP
Mar 4, 2020
Manufacturing Plant Locations
New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
Penn Life Sciences Llc has filed for 1 generic for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Penn Life.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL
injectable
Prescription
INJECTION
AP
Jan 10, 2020
10. TEVA PARENTERAL
Teva Parenteral Medicines Inc has filed for 2 different strengths of generic version for Thiotepa. Given below are the
details of the strengths of this generic introduced by
Teva Parenteral.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
injectable
Discontinued
INJECTION
N/A
Apr 20, 2001
30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
injectable
Discontinued
INJECTION
N/A
Apr 20, 2001
Manufacturing Plant Locations
New
Teva Parenteral'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 Teva Parenteral as present at those locations.
Country
City
Firm Name
United States
Irvine
Teva Parenteral Medicines, Inc.
11. WEST-WARD PHARMS INT
West-ward Pharmaceuticals International Ltd has filed for 1 generic for Thiotepa. Given below are the
details of the strengths of this generic introduced by
West-ward Pharms Int.
