Darifenacin Hydrobromide Patent Expiration

Darifenacin Hydrobromide is Used for treating a disease of altered motility or tone of smooth muscle and urinary incontinence. It was first introduced by Abbvie Inc in its drug Enablex on Dec 22, 2004. 10 different companies have introduced drugs containing Darifenacin Hydrobromide.


Darifenacin Hydrobromide Patents

Given below is the list of patents protecting Darifenacin Hydrobromide, 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
Enablex US6106864 Pharmaceutical formulations containing darifenacin Aug 21, 2016

(Expired)

Abbvie
Enablex US5096890 Pyrrolidine derivatives Mar 13, 2015

(Expired)

Abbvie



Darifenacin Hydrobromide's Family Patents

Family Patents

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Darifenacin Hydrobromide Generic API Manufacturers

Several generic applications have been filed for Darifenacin Hydrobromide. The first generic version for Darifenacin Hydrobromide was by Endo Operations Ltd and was approved on Mar 13, 2015. And the latest generic version is by Polygen Pharmaceuticals Inc and was approved on Jan 6, 2020.

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


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Dec 8, 2017
EQ 15MG BASE

tablet, extended release Prescription ORAL AB Dec 8, 2017


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. 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
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Sep 19, 2016
EQ 15MG BASE

tablet, extended release Prescription ORAL AB Sep 19, 2016


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
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Sep 1, 2016
EQ 15MG BASE

tablet, extended release Prescription ORAL AB Sep 1, 2016


Manufacturing Plant Locations
New

Cipla'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 Cipla as present at those locations.

Country City Firm Name
India
Bengaluru Cipla Limited
Bangalore Cipla Ltd.
Vasco Da Gama Cipla Limited
Pithampur, District Dhar Cipla Limited
Mumbai Cipla Limited
Raigad Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.





4. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. 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
EQ 7.5MG BASE

tablet, extended release Discontinued ORAL N/A Mar 13, 2015
EQ 15MG BASE

tablet, extended release Discontinued ORAL N/A Mar 13, 2015





5. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 7.5MG BASE

tablet, extended release Discontinued ORAL N/A Oct 12, 2016
EQ 15MG BASE

tablet, extended release Discontinued ORAL N/A Oct 12, 2016


Manufacturing Plant Locations
New

Jubilant Generics'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 Jubilant Generics as present at those locations.

Country City Firm Name
India
Roorkee Jubilant Generics Limited





6. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. All of these versions come by the name DARIFENACIN. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Jul 28, 2017
EQ 15MG BASE

(reference standard)

tablet, extended release Prescription ORAL AB Jul 28, 2017





7. POLYGEN PHARMS

Polygen Pharmaceuticals Inc has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Polygen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Jan 6, 2020
EQ 15MG BASE

tablet, extended release Prescription ORAL AB Jan 6, 2020





8. TORRENT

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE

tablet, extended release Prescription ORAL AB Nov 17, 2016
EQ 7.5MG BASE

tablet, extended release Prescription ORAL AB Nov 17, 2016


Manufacturing Plant Locations
New

Torrent'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 Torrent as present at those locations.

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Kalamazoo Torrent Pharma Inc.
Basking Ridge Torrent Pharma Inc.





9. XIROMED

Xiromed Pharma Espana Sl has filed for 2 different strengths of generic version for Darifenacin Hydrobromide. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 15MG BASE

tablet, extended release Discontinued ORAL N/A Oct 22, 2019
EQ 7.5MG BASE

tablet, extended release Discontinued ORAL N/A Oct 22, 2019


Manufacturing Plant Locations
New

Xiromed'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 Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC