Balsalazide Disodium Patent Expiration
Balsalazide Disodium is Used for treating mildly to moderately active ulcerative colitis in male patients. It was first introduced by Valeant Pharmaceuticals International
Balsalazide Disodium Patents
Given below is the list of patents protecting Balsalazide Disodium, 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 |
|---|---|---|---|---|
| Giazo | US8497256 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males | Jun 23, 2031 | Valeant Pharms Intl |
| Colazal |
US7452872 (Pediatric) | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Feb 24, 2027 | Valeant Pharms Intl |
| Colazal |
US7625884 (Pediatric) | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Feb 24, 2027 | Valeant Pharms Intl |
| Colazal | US7452872 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Aug 24, 2026 | Valeant Pharms Intl |
| Colazal | US7625884 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Aug 24, 2026 | Valeant Pharms Intl |
| Giazo | US7452872 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Aug 24, 2026 | Valeant Pharms Intl |
| Giazo | US7625884 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Aug 24, 2026 | Valeant Pharms Intl |
| Giazo | US9192616 | Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives | Aug 02, 2026 | Valeant Pharms Intl |
| Giazo | US6197341 | Formulations of balsalazide and its derivatives |
Mar 13, 2018
(Expired) | Valeant Pharms Intl |
Balsalazide Disodium's Family Patents
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Balsalazide Disodium Generic API Manufacturers
Several generic applications have been filed for Balsalazide Disodium. The first generic version for Balsalazide Disodium was by Hikma Pharmaceuticals Usa Inc and was approved on Dec 28, 2007. And the latest generic version is by Carnegie Pharmaceuticals Llc and was approved on Apr 3, 2025.
Given below is the list of companies who have filed for Balsalazide Disodium generic, along with the locations of their manufacturing plants worldwide.
1. APOTEX INC
Apotex Inc Etobicoke Site has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Apotex Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | capsule | Prescription | ORAL | AB | Dec 28, 2007 |
Manufacturing Plant Locations New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| Canada |
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2. CARNEGIE
Carnegie Pharmaceuticals Llc has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Carnegie.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | capsule | Prescription | ORAL | AB | Apr 3, 2025 |
Manufacturing Plant Locations New
Carnegie'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 Carnegie as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
3. ESJAY PHARMA
Esjay Pharma Llc has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Esjay Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | capsule | Discontinued | ORAL | N/A | Dec 28, 2007 |
4. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | capsule | Prescription | ORAL | AB | Dec 28, 2007 |
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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5. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.1GM | tablet | Discontinued | ORAL | N/A | Sep 8, 2015 |
Manufacturing Plant Locations New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
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| India |
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6. ZYDUS LIFESCIENCES
Zydus Lifesciences Global Fze has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | capsule | Prescription | ORAL | AB | Jun 8, 2023 |
Manufacturing Plant Locations New
Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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