Risedronate Sodium Patent Expiration

Risedronate Sodium is Used for prevention and treatment of osteoporosis, including in postmenopausal women, as well as for treating Paget's disease. It was first introduced by Allergan Pharmaceuticals International Ltd in its drug Actonel on Mar 27, 1998. Another drug containing Risedronate Sodium is Atelvia. 12 different companies have introduced drugs containing Risedronate Sodium.


Risedronate Sodium Patents

Given below is the list of patents protecting Risedronate 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
Atelvia US7645459 Dosage forms of bisphosphonates Jan 09, 2028 Apil
Atelvia US7645460 Dosage forms of risedronate Jan 09, 2028 Apil
Atelvia US8246989 Dosage forms of bisphosphonates Jan 16, 2026 Apil
Actonel US7192938

(Pediatric)

Method of treatment using bisphosphonic acid Nov 06, 2023

(Expired)

Apil
Actonel US7718634

(Pediatric)

Method of treatment using bisphosphonic acid Nov 06, 2023

(Expired)

Apil
Actonel US7192938 Method of treatment using bisphosphonic acid May 06, 2023

(Expired)

Apil
Actonel US7718634 Method of treatment using bisphosphonic acid May 06, 2023

(Expired)

Apil
Actonel US6465443

(Pediatric)

Method for inhibiting bone resorption Feb 14, 2019

(Expired)

Apil
Actonel US5994329

(Pediatric)

Method for inhibiting bone resorption Jan 17, 2019

(Expired)

Apil
Actonel US6015801

(Pediatric)

Method for inhibiting bone resorption Jan 17, 2019

(Expired)

Apil
Actonel US6432932

(Pediatric)

Method for inhibiting bone resorption Jan 17, 2019

(Expired)

Apil
Actonel US6165513

(Pediatric)

Film-coated tablet for improved upper gastrointestinal tract safety Dec 10, 2018

(Expired)

Apil
Actonel US6465443 Method for inhibiting bone resorption Aug 14, 2018

(Expired)

Apil
Actonel US5994329 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

Apil
Actonel US6015801 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

Apil
Actonel US6432932 Method for inhibiting bone resorption Jul 17, 2018

(Expired)

Apil
Actonel US6165513 Film-coated tablet for improved upper gastrointestinal tract safety Jun 10, 2018

(Expired)

Apil
Actonel US5583122

(Pediatric)

Pharmaceutical compositions containing geminal diphosphonates Jun 10, 2014

(Expired)

Apil
Atelvia US5583122

(Pediatric)

Pharmaceutical compositions containing geminal diphosphonates Jun 10, 2014

(Expired)

Apil
Atelvia US5622721 Dosage forms of risedronate Apr 21, 2014

(Expired)

Apil
Actonel US5583122 Pharmaceutical compositions containing geminal diphosphonates Dec 10, 2013

(Expired)

Apil
Atelvia US5583122 Pharmaceutical compositions containing geminal diphosphonates Dec 10, 2013

(Expired)

Apil



Risedronate Sodium's Family Patents

Family Patents

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Risedronate Sodium Generics

Several generic applications have been filed for Risedronate Sodium. The first generic version for Risedronate Sodium was by Teva Pharmaceuticals Usa and was approved on Oct 5, 2007. And the latest generic version is by Sun Pharmaceutical Industries Ltd and was approved on Jul 9, 2019.

Given below is the list of companies who have filed for Risedronate Sodium generic.


1. APOTEX

Apotex Inc has filed for 3 different strengths of generic version for Risedronate 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
75MG tablet Prescription ORAL AB Jun 10, 2014
150MG tablet Prescription ORAL AB Jun 10, 2014
35MG tablet Prescription ORAL AB Nov 30, 2015


2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Risedronate 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
150MG tablet Prescription ORAL BX Oct 21, 2016


3. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Risedronate Sodium. 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
5MG tablet Prescription ORAL AB Nov 30, 2015
30MG tablet Prescription ORAL AB Nov 30, 2015
35MG tablet Prescription ORAL AB Nov 30, 2015


4. HANGZHOU BINJIANG

Hangzhou Minsheng Binjiang Pharmaceutical Co Ltd has filed for 1 generic for Risedronate 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
35MG tablet Discontinued ORAL N/A Feb 15, 2019


5. IMPAX LABS INC

Impax Laboratories Inc has filed for 1 generic for Risedronate 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
35MG tablet, delayed release Discontinued ORAL N/A Jun 29, 2018


6. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Risedronate Sodium. 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
5MG tablet Prescription ORAL AB Dec 9, 2015
30MG tablet Prescription ORAL AB Dec 9, 2015
35MG tablet Prescription ORAL AB Nov 29, 2016


7. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 5 different strengths of generic version for Risedronate Sodium. 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
75MG tablet Discontinued ORAL N/A Jun 10, 2014
150MG tablet Discontinued ORAL N/A Jun 10, 2014
5MG tablet Discontinued ORAL N/A Nov 30, 2015
30MG tablet Discontinued ORAL N/A Nov 30, 2015
35MG tablet Discontinued ORAL N/A Nov 30, 2015


8. ORBION PHARMS

Orbion Pharmaceuticals Private Ltd has filed for 2 different strengths of generic version for Risedronate Sodium. Given below are the details of the strengths of this generic introduced by Orbion Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Prescription ORAL AB May 13, 2019
35MG tablet Prescription ORAL AB May 13, 2019


9. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 5 different strengths of generic version for Risedronate 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
75MG tablet Prescription ORAL AB Jun 10, 2014
150MG tablet Prescription ORAL AB Jun 10, 2014
5MG tablet Prescription ORAL AB Nov 30, 2015
30MG tablet Prescription ORAL AB Nov 30, 2015
35MG tablet, delayed release Prescription ORAL AB Jul 9, 2019


10. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Risedronate Sodium. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Prescription ORAL AB Oct 5, 2007
35MG tablet, delayed release Prescription ORAL AB May 18, 2015
5MG tablet Prescription ORAL AB Oct 5, 2007
150MG tablet Prescription ORAL AB Jun 13, 2014


11. ZYDUS PHARMS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
35MG tablet, delayed release Discontinued ORAL N/A Sep 11, 2018