Thiotepa Patent Expiration
Thiotepa was first introduced by Immunex Corp
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.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Tepylute | US11975013 | Stable formulations comprising thiotepa | Aug 16, 2041 | Shorla |
| Tepadina And Sodium Chloride | US9931458 | Multi chamber flexible bag and methods of using same | May 31, 2037 | Adienne Sa |
Thiotepa's Family Patents
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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 |
| |||||||||||||||||
4. GLAND
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.
| 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 |
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 |
| |||||||||||||||
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 |
| |||||||||
| Portugal |
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| Jordan |
| |||||||||
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 |
|---|---|---|---|---|---|
| 100MG/VIAL | powder | Prescription | INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | AP | Dec 26, 2023 |
| 15MG/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.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||||||||
| United States |
| |||||||||||||||||||||
9. PENN LIFE
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 |
| |||
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.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 2, 2001 |