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Guaifenesin Patent Expiration

Guaifenesin is Used for treating respiratory conditions by promoting the expulsion of mucus from the lungs. It was first introduced by Rb Health Us Llc in its drug Mucinex on Jul 12, 2002. 10 different companies have introduced drugs containing Guaifenesin.


Guaifenesin Patents

Given below is the list of patents protecting Guaifenesin, 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
Mucinex US6372252 Guaifenesin sustained release formulation and tablets Apr 28, 2020

(Expired)

 Rb Hlth
Mucinex US6955821 Sustained release formulations of guaifenesin and additional drug ingredients Apr 28, 2020

(Expired)

 Rb Hlth
Mucinex US7838032 Sustained release of guaifenesin Apr 28, 2020

(Expired)

 Rb Hlth



Guaifenesin's Family Patents

Family Patents

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Guaifenesin Generic API Manufacturers

Several generic applications have been filed for Guaifenesin. The first generic version for Guaifenesin was by Perrigo R And D Co and was approved on Nov 23, 2011. And the latest generic version is by Marksans Pharma Ltd and was approved on Aug 21, 2023.

Given below is the list of companies who have filed for Guaifenesin generic, along with the locations of their manufacturing plants worldwide.


1. ACTAVIS LABS FL

Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Guaifenesin. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.2GM

tablet, extended release Over the counter ORAL N/A Sep 3, 2015





2. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.2GM

tablet, extended release Over the counter ORAL N/A Jul 11, 2018
600MG

tablet, extended release Over the counter ORAL N/A Jul 11, 2018





3. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Oct 21, 2019
1.2GM

tablet, extended release Over the counter ORAL N/A Oct 21, 2019


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





4. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Mar 15, 2022
1.2GM

tablet, extended release Over the counter ORAL N/A Mar 15, 2022





5. GRANULES

Granules India Ltd has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Granules.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.2GM

tablet, extended release Over the counter ORAL N/A May 8, 2020
600MG

tablet, extended release Over the counter ORAL N/A May 8, 2020


Manufacturing Plant Locations
New

Granules'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 Granules as present at those locations.

Country City Firm Name
United States
Manassas Granules Consumer Health Inc.
Chantilly Granules Pharmaceuticals Inc.
India
Parawada Mandal Granules India Limited
Sangareddy District Granules India Limited
Secunderabad Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Visakhapatnam Granules India Limited





6. GUARDIAN DRUG

Guardian Drug Co has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Guardian Drug.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Sep 6, 2017
1.2GM

tablet, extended release Over the counter ORAL N/A Sep 6, 2017


Manufacturing Plant Locations
New

Guardian Drug'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 Guardian Drug as present at those locations.

Country City Firm Name
United States
Dayton Guardian Drug Co. Inc.





7. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Marksans Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Aug 21, 2023
1.2GM

tablet, extended release Over the counter ORAL N/A Aug 21, 2023


Manufacturing Plant Locations
New

Marksans 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 Marksans Pharma as present at those locations.

Country City Firm Name
United States
Commack Marksans Pharmaceuticals Ltd
India
Verna Marksans Pharma Limited





8. OHM LABS INC

Ohm Laboratories Inc has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Ohm Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Jul 16, 2018
1.2GM

tablet, extended release Over the counter ORAL N/A Jul 16, 2018





9. PERRIGO R AND D

Perrigo R And D Co has filed for 2 different strengths of generic version for Guaifenesin. Given below are the details of the strengths of this generic introduced by Perrigo R And D.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet, extended release Over the counter ORAL N/A Nov 23, 2011
1.2GM

tablet, extended release Over the counter ORAL N/A Nov 5, 2020