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Doxylamine Succinate; Pyridoxine Hydrochloride Patent Expiration

Doxylamine Succinate; Pyridoxine Hydrochloride is Used for treating nausea and vomiting of pregnancy in women who do not respond to conservative management. It was first introduced by Sanofi Aventis Us Llc in its drug Bendectin on Approved Prior to Jan 1, 1982. Other drugs containing Doxylamine Succinate; Pyridoxine Hydrochloride are Bonjesta, Diclegis. 6 different companies have introduced drugs containing Doxylamine Succinate; Pyridoxine Hydrochloride.


Doxylamine Succinate; Pyridoxine Hydrochloride Patents

Given below is the list of patents protecting Doxylamine Succinate; Pyridoxine Hydrochloride, 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
Bonjesta US9089489 Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof Feb 18, 2033 Duchesnay
Bonjesta US9375404 Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof Feb 18, 2033 Duchesnay
Bonjesta US9526703 Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof Feb 18, 2033 Duchesnay
Bonjesta US9937132 Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof Feb 18, 2033 Duchesnay
Diclegis US6340695 Rapid onset formulation Jun 21, 2021

(Expired)

 Duchesnay
Bonjesta US7560122 Pharmaceutical dosage form bearing pregnancy-friendly indicia Jan 25, 2019

(Expired)

 Duchesnay
Diclegis US7560122 Pharmaceutical dosage form bearing pregnancy-friendly indicia Jan 25, 2019

(Expired)

 Duchesnay



Doxylamine Succinate; Pyridoxine Hydrochloride's Family Patents

Family Patents

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Doxylamine Succinate; Pyridoxine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Doxylamine Succinate; Pyridoxine Hydrochloride. The first generic version for Doxylamine Succinate; Pyridoxine Hydrochloride was by Actavis Laboratories Fl Inc and was approved on Aug 19, 2016. And the latest generic version is by Bionpharma Inc and was approved on Aug 4, 2023.

Given below is the list of companies who have filed for Doxylamine Succinate; Pyridoxine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 2 different strengths of generic version for Doxylamine Succinate; Pyridoxine Hydrochloride. All of these versions come by the name DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 10MG

tablet, delayed release Prescription ORAL AB Aug 19, 2016
20MG; 20MG

tablet, extended release Discontinued ORAL N/A Mar 1, 2022





2. BIONPHARMA

Bionpharma Inc has filed for 1 generic for Doxylamine Succinate; Pyridoxine Hydrochloride. This 10mg;10mg version comes by the name DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 10MG

tablet, delayed release Prescription ORAL AB Aug 4, 2023


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





3. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Doxylamine Succinate; Pyridoxine Hydrochloride. This 10mg;10mg version comes by the name DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE. 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
10MG; 10MG

tablet, delayed release Prescription ORAL AB Dec 6, 2017





4. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 1 generic for Doxylamine Succinate; Pyridoxine Hydrochloride. This 10mg;10mg version comes by the name DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG; 10MG

tablet, delayed release Prescription ORAL AB Jul 6, 2020