Sodium Phenylbutyrate Patent Expiration
Sodium Phenylbutyrate is Used for treating urea cycle disorders involving enzyme deficiencies. It was first introduced by Horizon Therapeutics Us Holding Llc
Sodium Phenylbutyrate Patents
Given below is the list of patents protecting Sodium Phenylbutyrate, 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 |
|---|---|---|---|---|
| Olpruva | US11154521 | Palatable compositions including sodium phenylbutyrate and uses thereof | Oct 17, 2036 | Acer |
| Olpruva | US11202767 | Methods of treating urea cycle disorders and maple syrup urine disease | Oct 17, 2036 | Acer |
| Olpruva | US11433041 | Palatable compositions including sodium phenylbutyrate and uses thereof | Oct 17, 2036 | Acer |
Sodium Phenylbutyrate's Family Patents
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Sodium Phenylbutyrate Generic API Manufacturers
Several generic applications have been filed for Sodium Phenylbutyrate. The first generic version for Sodium Phenylbutyrate was by Alvogen Inc and was approved on Nov 18, 2011. And the latest generic version is by Glenmark Pharmaceuticals Ltd and was approved on Nov 1, 2022.
Given below is the list of companies who have filed for Sodium Phenylbutyrate generic, along with the locations of their manufacturing plants worldwide.
1. ALVOGEN
Alvogen Inc has filed for 1 generic for Sodium Phenylbutyrate. Given below are the details of the strengths of this generic introduced by Alvogen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | Nov 18, 2011 |
Manufacturing Plant Locations New
Alvogen'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 Alvogen as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
2. ENDO OPERATIONS
Endo Operations Ltd has filed for 2 different strengths of generic version for Sodium Phenylbutyrate. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Apr 15, 2016 |
| 3GM/TEASPOONFUL | powder | Prescription | ORAL | AB | Jun 15, 2016 |
3. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Sodium Phenylbutyrate. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Nov 1, 2022 |
4. SIGMAPHARM LABS LLC
Sigmapharm Laboratories Llc has filed for 1 generic for Sodium Phenylbutyrate. Given below are the details of the strengths of this generic introduced by Sigmapharm Labs Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3GM/TEASPOONFUL | powder | Prescription | ORAL | AB | Mar 22, 2013 |