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 in its drug Buphenyl on Apr 30, 1996. Other drugs containing Sodium Phenylbutyrate are Olpruva, Pheburane. 7 different companies have introduced drugs containing Sodium Phenylbutyrate.


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


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Sodium Phenylbutyrate Generics

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.


1. 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


2. 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


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. 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