Cladribine Patent Expiration
Cladribine is used for treating multiple sclerosis (MS) with oral cladribine. It was first introduced by Janssen Pharmaceuticals Inc
Cladribine Patents
Given below is the list of patents protecting Cladribine, 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 |
|---|---|---|---|---|
| Mavenclad | US10849919 | Cladribine regimen for treating progressive forms of multiple sclerosis | Nov 23, 2038 | Emd Serono Inc |
| Mavenclad | US7713947 | Cladribine regimen for treating multiple sclerosis | Oct 16, 2026 | Emd Serono Inc |
| Mavenclad | US8377903 | Cladribine regimen for treating multiple sclerosis | May 31, 2026 | Emd Serono Inc |
| Mavenclad | US7888328 | Oral formulations of cladribine |
Apr 11, 2024
(Expired) | Emd Serono Inc |
| Mavenclad | US8785415 | Oral formulations of cladribine |
Apr 11, 2024
(Expired) | Emd Serono Inc |
Cladribine's Family Patents
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Cladribine Generic API Manufacturers
Several generic applications have been filed for Cladribine. The first generic version for Cladribine was by Hikma Pharmaceuticals Usa Inc and was approved on Feb 28, 2000. And the latest generic version is by Hisun Pharmaceutical (Hangzhou) Co Ltd and was approved on Nov 25, 2019.
Given below is the list of companies who have filed for Cladribine generic, along with the locations of their manufacturing plants worldwide.
1. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Cladribine. 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 |
|---|---|---|---|---|---|
| 1MG/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 22, 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 |
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2. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Cladribine. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Feb 28, 2000 |
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 |
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| Portugal |
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| Jordan |
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3. HISUN PHARM HANGZHOU
Hisun Pharmaceutical (hangzhou) Co Ltd has filed for 1 generic for Cladribine. Given below are the details of the strengths of this generic introduced by Hisun Pharm Hangzhou.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Prescription | INJECTION | AP | Nov 25, 2019 |
4. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 1 generic for Cladribine. 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 |
|---|---|---|---|---|---|
| 1MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 6, 2011 |