Galantamine Hydrobromide Patent Expiration

Galantamine Hydrobromide was first introduced by Janssen Pharmaceuticals Inc in its drug Razadyne on Feb 28, 2001. Another drug containing Galantamine Hydrobromide is Razadyne Er. 17 different companies have introduced drugs containing Galantamine Hydrobromide.


Galantamine Hydrobromide Patents

Given below is the list of patents protecting Galantamine 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
Razadyne Er US7160559 Controlled release galantamine composition Dec 20, 2019

(Expired)

Janssen Pharms
Razadyne US6099863 Fast-dissolving galanthamine hydrobromide tablet Jun 06, 2017

(Expired)

Janssen Pharms
Razadyne US6358527 Fast-dissolving galanthamine hydrobromide tablet Jun 06, 2017

(Expired)

Janssen Pharms



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Galantamine Hydrobromide's patents.

Given below is the list recent legal activities going on the following patents of Galantamine Hydrobromide.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 28 Jun, 2018 US7160559
Patent Issue Date Used in PTA Calculation 09 Jan, 2007 US7160559
Recordation of Patent Grant Mailed 09 Jan, 2007 US7160559
Issue Notification Mailed 20 Dec, 2006 US7160559
Dispatch to FDC 06 Dec, 2006 US7160559
Mail Miscellaneous Communication to Applicant 30 Nov, 2006 US7160559
Miscellaneous Communication to Applicant - No Action Count 25 Nov, 2006 US7160559
Mail-Petition Decision - Dismissed 19 Sep, 2006 US7160559
Application Is Considered Ready for Issue 04 May, 2006 US7160559
Issue Fee Payment Verified 27 Apr, 2006 US7160559


Galantamine Hydrobromide's Family Patents

Family Patents

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Galantamine Hydrobromide Generic API Manufacturers

Several generic applications have been filed for Galantamine Hydrobromide. The first generic version for Galantamine Hydrobromide was by Barr Laboratories Inc and was approved on Aug 28, 2008. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Aug 5, 2016.

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


1. APOTEX INC

Apotex Inc. has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Discontinued ORAL N/A Sep 27, 2011
EQ 8MG BASE

tablet Discontinued ORAL N/A Sep 27, 2011
EQ 4MG BASE

tablet Discontinued ORAL N/A Sep 27, 2011


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Galantamine 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 8MG BASE

(reference standard)

capsule, extended release Prescription ORAL AB Aug 5, 2016
EQ 16MG BASE

capsule, extended release Prescription ORAL AB Aug 5, 2016
EQ 24MG BASE

capsule, extended release Prescription ORAL AB Aug 5, 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
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. AUROBINDO PHARMA LTD

Aurobindo Pharma Limited has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Prescription ORAL AB Mar 29, 2011
EQ 8MG BASE

tablet Prescription ORAL AB Mar 29, 2011
EQ 12MG BASE

tablet Prescription ORAL AB Mar 29, 2011


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd'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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





4. BARR

Barr Laboratories Inc has filed for 5 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE

tablet Prescription ORAL AB Aug 28, 2008
EQ 12MG BASE

tablet Prescription ORAL AB Aug 28, 2008
EQ 8MG BASE

capsule, extended release Prescription ORAL AB Sep 15, 2008
EQ 16MG BASE

capsule, extended release Prescription ORAL AB Sep 15, 2008
EQ 24MG BASE

capsule, extended release Prescription ORAL AB Sep 15, 2008


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Madison Barriques Holding Company, LLC
Buffalo Barrel and Brine Inc
Englewood Barrett E. Cowan, MD
Hereford Barrett and Crofoot Feedyard, West
Greenwood Barr Enterprises, Inc.
Lake Barrington Barrington Ventures, Ltd
Arecibo Barreto Dairy, Inc.
Live Oak Barrington Dairy Farm
Brainerd Barrett Ag Service, Inc.
Commerce Barreras Meat Co
Barrett Barrett Farm Supply, Inc.
Lee Barrington Coffee Roasting Company, Inc.
Belvidere Barred Woods, LLC
Paso Robles Barreto Cellars
Somerset Barrett Distribution Centers Inc
Franklin Barrett Distribution Centers, Inc.
Forest Barr Laboratories Inc.
Memphis Barrett Distribution Centers
Machipongo Barrier Island Seafood
Swartz Creek Barrett Donut Mixes, Inc..
Curtis Bay Barrett Distribution Center
Newton Barrett Technology, LLC
Dillon Barretts Minerals Inc
Davie Barrier Technologies LLC
Montezuma Barrington Dairies
Hereford Barrett and Crofoot, LLP
Harrison Barrington Chemical Corporation
Randolph Barrett Farm
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





5. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Discontinued ORAL N/A Jul 9, 2009
EQ 8MG BASE

tablet Discontinued ORAL N/A Jul 9, 2009
EQ 4MG BASE

tablet Discontinued ORAL N/A Jul 9, 2009





6. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Prescription ORAL AB Sep 11, 2008
EQ 8MG BASE

tablet Prescription ORAL AB Sep 11, 2008
EQ 4MG BASE

tablet Prescription ORAL AB Sep 11, 2008





7. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Discontinued ORAL N/A Sep 15, 2009
EQ 4MG BASE

tablet Discontinued ORAL N/A Sep 15, 2009
EQ 8MG BASE

tablet Discontinued ORAL N/A Sep 15, 2009


Manufacturing Plant Locations
New

Heritage Pharma'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 Heritage Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Heritage Pharmaceuticals Inc
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS





8. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG/ML

(reference standard)

solution Prescription ORAL N/A Jan 30, 2009
EQ 4MG BASE

tablet Discontinued ORAL N/A Feb 11, 2009
EQ 12MG BASE

tablet Discontinued ORAL N/A Feb 11, 2009
EQ 8MG BASE

tablet Discontinued ORAL N/A Feb 11, 2009


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





9. IMPAX LABS

Impax Laboratories Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 16MG BASE

capsule, extended release Discontinued ORAL N/A May 27, 2009
EQ 8MG BASE

capsule, extended release Discontinued ORAL N/A May 27, 2009
EQ 24MG BASE

capsule, extended release Discontinued ORAL N/A May 27, 2009





10. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Discontinued ORAL N/A May 29, 2009
EQ 4MG BASE

tablet Discontinued ORAL N/A May 29, 2009
EQ 8MG BASE

tablet Discontinued ORAL N/A May 29, 2009


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





11. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 5 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Discontinued ORAL N/A Aug 28, 2008
EQ 8MG BASE

capsule, extended release Discontinued ORAL N/A Jan 24, 2011
EQ 4MG BASE

tablet Discontinued ORAL N/A Aug 28, 2008
EQ 24MG BASE

capsule, extended release Discontinued ORAL N/A Jan 24, 2011
EQ 16MG BASE

capsule, extended release Discontinued ORAL N/A Jan 24, 2011





12. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 8MG BASE

tablet Prescription ORAL AB Jun 22, 2009
EQ 4MG BASE

tablet Prescription ORAL AB Jun 22, 2009
EQ 12MG BASE

tablet Prescription ORAL AB Jun 22, 2009


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





13. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 8MG BASE

capsule, extended release Prescription ORAL AB Feb 2, 2011
EQ 24MG BASE

capsule, extended release Prescription ORAL AB Feb 2, 2011
EQ 16MG BASE

capsule, extended release Prescription ORAL AB Feb 2, 2011


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
India
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.





14. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 24MG BASE

capsule, extended release Prescription ORAL AB Dec 15, 2008
EQ 16MG BASE

capsule, extended release Prescription ORAL AB Dec 15, 2008
EQ 8MG BASE

capsule, extended release Prescription ORAL AB Dec 15, 2008





15. YABAO PHARM

Yabao Pharmaceutical Co Ltd Beijing has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Yabao Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 8MG BASE

tablet Prescription ORAL AB Feb 6, 2009
EQ 4MG BASE

(reference standard)

tablet Prescription ORAL AB Feb 6, 2009
EQ 12MG BASE

tablet Prescription ORAL AB Feb 6, 2009


Manufacturing Plant Locations
New

Yabao Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Yabao Pharm as present at those locations.

Country City Firm Name
China
Tongzhou Yabao Pharmaceutical Co., Ltd. Beijing
Yuncheng Yabao Pharmaceutical Group Co., Ltd





16. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Galantamine Hydrobromide. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 12MG BASE

tablet Prescription ORAL AB Feb 17, 2011
EQ 8MG BASE

tablet Prescription ORAL AB Feb 17, 2011
EQ 4MG BASE

tablet Prescription ORAL AB Feb 17, 2011