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
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
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Risedronate Sodium Generic API Manufacturers
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, along with the locations of their manufacturing plants worldwide.
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 |
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 |
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| Canada |
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| India |
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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 |
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 |
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| United States |
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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 |
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 |
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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 | Discontinued | ORAL | N/A | Jul 9, 2019 |
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 |
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| India |
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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 |