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Alendronate Sodium Patent Expiration

Alendronate Sodium was first introduced by Organon Llc A Sub Of Organon And Co in its drug Fosamax on Sep 29, 1995. Another drug containing Alendronate Sodium is Binosto. 19 different companies have introduced drugs containing Alendronate Sodium.


Alendronate Sodium Patents

Given below is the list of patents protecting Alendronate Sodium, 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
Binosto US9592195 Stable effervescent bisphosphonate formulations with rapid solubilization characteristics Dec 05, 2031 Radius
Binosto US7488496 Effervescent compositions comprising bisphosphonates and methods related thereto Aug 11, 2023

(Expired)

 Radius
Binosto US7964212 Effervescent compositions comprising phosphonates and methods related thereto Mar 06, 2023

(Expired)

 Radius
Fosamax US5994329

(Pediatric)

 Method for inhibiting bone resorption Jan 17, 2019

(Expired)

 Merck
Fosamax US6015801

(Pediatric)

 Method for inhibiting bone resorption Jan 17, 2019

(Expired)

 Merck
Fosamax US6225294

(Pediatric)

 Method for inhibiting bone resorption Jan 17, 2019

(Expired)

 Merck
Fosamax US5994329 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

 Merck
Fosamax US6015801 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

 Merck
Fosamax US6225294 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

 Merck
Fosamax US5462932

(Pediatric)

 Oral liquid alendronate formulations Nov 17, 2014

(Expired)

 Merck
Fosamax US5462932 Oral liquid alendronate formulations May 17, 2014

(Expired)

 Merck
Fosamax US5358941

(Pediatric)

 Dry mix formulation for bisphosphonic acids with lactose Jun 02, 2013

(Expired)

 Organon
Fosamax US5681590

(Pediatric)

 Dry mix formulation for bisphosphonic acids Jun 02, 2013

(Expired)

 Organon
Fosamax US6090410

(Pediatric)

 Dry mix formulation for bisphosphonic acids Jun 02, 2013

(Expired)

 Organon
Fosamax US6194004

(Pediatric)

 Dry mix formulation for bisphosphonic acids Jun 02, 2013

(Expired)

 Organon
Fosamax US5358941 Dry mix formulation for bisphosphonic acids with lactose Dec 02, 2012

(Expired)

 Organon
Fosamax US5681590 Dry mix formulation for bisphosphonic acids Dec 02, 2012

(Expired)

 Organon
Fosamax US6090410 Dry mix formulation for bisphosphonic acids Dec 02, 2012

(Expired)

 Organon
Fosamax US6194004 Dry mix formulation for bisphosphonic acids Dec 02, 2012

(Expired)

 Organon



Alendronate Sodium's Family Patents

Family Patents

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Alendronate Sodium Generic API Manufacturers

Several generic applications have been filed for Alendronate Sodium. The first generic version for Alendronate Sodium was by Impax Laboratories Inc and was approved on Feb 6, 2008. And the latest generic version is by Ipca Laboratories Ltd and was approved on Jun 4, 2024.

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


1. APOTEX

Apotex Inc has filed for 4 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 10MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 35MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 70MG BASE

tablet Prescription ORAL AB Aug 4, 2008


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Alendronate Sodium. 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 10MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 35MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 70MG BASE

tablet Prescription ORAL AB Aug 4, 2008


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
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
United States
East Windsor Aurobindo Pharma USA Inc





3. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 5 different strengths of generic version for Alendronate Sodium. 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 35MG BASE

tablet Discontinued ORAL N/A Apr 22, 2009
EQ 70MG BASE

tablet Discontinued ORAL N/A Apr 22, 2009
EQ 5MG BASE

tablet Discontinued ORAL N/A Apr 22, 2009
EQ 10MG BASE

tablet Discontinued ORAL N/A Apr 22, 2009
EQ 40MG BASE

tablet Discontinued ORAL N/A Apr 22, 2009





4. CIPLA

Cipla Ltd has filed for 5 different strengths of generic version for Alendronate Sodium. 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 5MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 10MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 35MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 40MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 70MG BASE

tablet Prescription ORAL AB Aug 4, 2008


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
Vasco Da Gama Cipla Limited
Raigad Cipla Limited
Pithampur, District Dhar Cipla Limited
Bangalore Cipla Ltd.
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Mumbai Cipla Limited
Bengaluru Cipla Limited





5. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Alendronate Sodium. 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 5MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 10MG BASE

tablet Prescription ORAL AB Aug 4, 2008





6. HANGZHOU BINJIANG

Hangzhou Minsheng Binjiang Pharmaceutical Co Ltd has filed for 4 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Hangzhou Binjiang.

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

tablet Prescription ORAL AB Sep 24, 2009
EQ 5MG BASE

tablet Prescription ORAL AB Sep 24, 2009
EQ 35MG BASE

tablet Prescription ORAL AB Sep 24, 2009
EQ 70MG BASE

tablet Prescription ORAL AB Sep 24, 2009





7. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 70MG BASE/75ML

(reference standard)

solution Prescription ORAL AA Feb 25, 2013


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





8. IMPAX LABS INC

Impax Laboratories Inc has filed for 5 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008
EQ 10MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008
EQ 35MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008
EQ 40MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008
EQ 70MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008





9. IPCA LABS LTD

Ipca Laboratories Ltd has filed for 4 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.

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

tablet Prescription ORAL AB Jun 4, 2024
EQ 40MG BASE

tablet Prescription ORAL AB Jun 4, 2024
EQ 35MG BASE

tablet Prescription ORAL AB Jun 4, 2024
EQ 70MG BASE

tablet Prescription ORAL AB Jun 4, 2024





10. JUBILANT CADISTA

Jubilant Cadista Pharmaceuticals Inc has filed for 4 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Jubilant Cadista.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 35MG BASE

tablet Discontinued ORAL N/A Feb 18, 2010
EQ 70MG BASE

tablet Discontinued ORAL N/A Feb 18, 2010
EQ 5MG BASE

tablet Discontinued ORAL N/A Feb 18, 2010
EQ 10MG BASE

tablet Discontinued ORAL N/A Feb 18, 2010


Manufacturing Plant Locations
New

Jubilant Cadista'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 Jubilant Cadista as present at those locations.

Country City Firm Name
United States
Salisbury Jubilant Cadista Pharmaceuticals, Inc.





11. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Alendronate Sodium. 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 35MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008
EQ 70MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008


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





12. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 1 generic for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 70MG BASE/75ML

solution Prescription ORAL AA May 11, 2023


Manufacturing Plant Locations
New

Novitium 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 Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC





13. RISING

Rising Pharma Holding Inc has filed for 4 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 35MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008
EQ 70MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008
EQ 5MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008
EQ 10MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





14. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Alendronate Sodium. 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 35MG BASE

tablet Prescription ORAL AB Sep 10, 2008
EQ 10MG BASE

tablet Prescription ORAL AB Sep 10, 2008
EQ 70MG BASE

tablet Prescription ORAL AB Sep 10, 2008
EQ 5MG BASE

tablet Prescription ORAL AB Sep 10, 2008


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





15. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Alendronate Sodium. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 70MG BASE

tablet Discontinued ORAL N/A Feb 6, 2008
EQ 35MG BASE

tablet Discontinued ORAL N/A Aug 4, 2008





16. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Alendronate Sodium. 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 35MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 40MG BASE

tablet Prescription ORAL AB Aug 4, 2008
EQ 70MG BASE

tablet Prescription ORAL AB Aug 4, 2008