Mitomycin Patent Expiration
Mitomycin was first introduced by Bristol Laboratories Inc Div Bristol Myers Co
Mitomycin Patents
Given below is the list of patents protecting Mitomycin, 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 |
|---|---|---|---|---|
| Jelmyto | US9040074 | Material and method for treating internal cavities | Jan 20, 2031 | Urogen Pharma |
| Jelmyto | US9950069 | Material and method for treating internal cavities | Jan 20, 2031 | Urogen Pharma |
| Mitosol | US9649428 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | May 21, 2029 | Mobius Therap |
| Mitosol | US7806265 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | Feb 01, 2029 | Mobius Therap |
| Mitosol | US9539241 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | Jan 02, 2028 | Mobius Therap |
| Mitosol | US8186511 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | Jul 19, 2026 | Mobius Therap |
| Mitosol | US9205075 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | Jul 19, 2026 | Mobius Therap |
Mitomycin's Family Patents
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Mitomycin Generic API Manufacturers
Several generic applications have been filed for Mitomycin. The first generic version for Mitomycin was by Bristol Myers Co and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Fresenius Kabi Usa Llc and was approved on Apr 5, 2024.
Given below is the list of companies who have filed for Mitomycin generic, along with the locations of their manufacturing plants worldwide.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 30, 1998 |
| 20MG/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 30, 1998 |
| 40MG/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | Aug 11, 2009 |
2. BRISTOL MYERS
Bristol Myers Co has filed for 3 different strengths of generic version for Mitomycin. All of these versions come by the name MUTAMYCIN. Given below are the details of the strengths of this generic introduced by Bristol Myers.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG/VIAL | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
| 5MG/VIAL | injectable | Discontinued | INJECTION | N/A | Approved Prior to Jan 1, 1982 |
| 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable | Discontinued | INJECTION | N/A | Mar 10, 1988 |
Manufacturing Plant Locations New
Bristol Myers'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 Bristol Myers as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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3. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Mitomycin. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 30, 2023 |
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 30, 2023 |
| 20MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 30, 2023 |
Manufacturing Plant Locations New
Eugia Pharma'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 Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
| |||||||
4. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Mitomycin. 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 |
|---|---|---|---|---|---|
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Apr 5, 2024 |
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Apr 5, 2024 |
| 20MG/VIAL | injectable | Prescription | INJECTION | AP | Apr 5, 2024 |
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 |
| |||||||||||||||||
5. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 3 different strengths of generic version for Mitomycin. 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 |
|---|---|---|---|---|---|
| 20MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 20, 2021 |
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 20, 2021 |
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Nov 22, 2022 |
6. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Dec 23, 1999 |
| 20MG/VIAL | injectable | Prescription | INJECTION | AP | Dec 23, 1999 |
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Jun 2, 1999 |
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 |
| |||||||||
| Jordan |
| |||||||||
7. HOSPIRA
Hospira Inc has filed for 1 generic for Mitomycin. 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/VIAL | injectable | Discontinued | INJECTION | N/A | Nov 29, 1995 |
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 |
| |||||||||||||
| United States |
| |||||||||||||
| Dominican Republic (the) |
| |||||||||||||
8. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the details of the strengths of this generic introduced by Meitheal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Sep 6, 2022 |
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Sep 8, 2022 |
| 20MG/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | Sep 8, 2022 |
9. RK PHARMA
Rk Pharma Inc has filed for 3 different strengths of generic version for Mitomycin. Given below are the details of the strengths of this generic introduced by Rk Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 13, 2017 |
| 20MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 13, 2017 |
| 40MG/VIAL | injectable | Prescription | INJECTION | AP | Oct 13, 2017 |
Manufacturing Plant Locations New
Rk Pharma'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 Rk Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||