Dexmethylphenidate Hydrochloride Patent Expiration
Dexmethylphenidate Hydrochloride is Used for treating attention deficit disorder and/or attention deficit hyperactivity disorder with once daily extended release dosages or bi-modal/pulsatile release compositions. It was first introduced by Sandoz Inc
Dexmethylphenidate Hydrochloride Patents
Given below is the list of patents protecting Dexmethylphenidate Hydrochloride, 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 |
|---|---|---|---|---|
| Focalin Xr | US6228398 | Multiparticulate modified release composition |
Nov 01, 2019
(Expired) | Sandoz |
| Focalin Xr | US6730325 | Multiparticulate modified release composition |
Nov 01, 2019
(Expired) | Sandoz |
| Focalin | US5908850 | Method of treating attention deficit disorders with d-threo methylphenidate |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin | US6355656 | Phenidate drug formulations having diminished abuse potential |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin | US6528530 | Phenidate drug formulations having diminished abuse potential |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US5837284 | Delivery of multiple doses of medications |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US5908850 | Method of treating attention deficit disorders with d-threo methylphenidate |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US6355656 | Phenidate drug formulations having diminished abuse potential |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US6528530 | Phenidate drug formulations having diminished abuse potential |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US6635284 | Delivery of multiple doses of medications |
Dec 04, 2015
(Expired) | Sandoz |
| Focalin Xr | US7431944 | Delivery of multiple doses of medications |
Dec 04, 2015
(Expired) | Sandoz |
Dexmethylphenidate Hydrochloride's Family Patents
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Dexmethylphenidate Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Dexmethylphenidate Hydrochloride. The first generic version for Dexmethylphenidate Hydrochloride was by Teva Pharmaceuticals Usa and was approved on Jan 29, 2007. And the latest generic version is by Ascent Pharmaceuticals Inc and was approved on Dec 8, 2021.
Given below is the list of companies who have filed for Dexmethylphenidate Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ABHAI INC
Abhai Inc has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Abhai Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
| 2.5MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
| 5MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
2. ADARE PHARMS INC
Adare Pharmaceuticals Inc has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Adare Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 40MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Oct 9, 2018 |
3. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Jul 19, 2019 |
| 2.5MG | tablet | Prescription | ORAL | AB | Jul 19, 2019 |
| 5MG | tablet | Prescription | ORAL | AB | Jul 19, 2019 |
4. ASCENT PHARMS INC
Ascent Pharmaceuticals Inc has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Dec 8, 2021 |
5. AUROLIFE PHARMA LLC
Aurolife Pharma Llc has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurolife Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG | capsule, extended release | Discontinued | ORAL | N/A | Aug 28, 2013 |
| 10MG | capsule, extended release | Discontinued | ORAL | N/A | Aug 25, 2015 |
| 15MG | capsule, extended release | Discontinued | ORAL | N/A | Aug 25, 2015 |
| 40MG | capsule, extended release | Discontinued | ORAL | N/A | Aug 25, 2015 |
| 5MG | capsule, extended release | Discontinued | ORAL | N/A | Aug 25, 2015 |
| 20MG | capsule, extended release | Discontinued | ORAL | N/A | Dec 21, 2015 |
| 25MG | capsule, extended release | Discontinued | ORAL | N/A | May 4, 2021 |
| 35MG | capsule, extended release | Discontinued | ORAL | N/A | May 4, 2021 |
Manufacturing Plant Locations New
Aurolife Pharma Llc'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 Aurolife Pharma Llc as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
6. BIONPHARMA
Bionpharma Inc has filed for 2 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Bionpharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Mar 24, 2020 |
| 10MG | tablet | Discontinued | ORAL | N/A | Mar 24, 2020 |
Manufacturing Plant Locations New
Bionpharma'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 Bionpharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
7. CEDIPROF INC
Cediprof Inc has filed for 2 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Cediprof Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 19, 2018 |
| 10MG | tablet | Prescription | ORAL | AB | Sep 19, 2018 |
8. ENDO OPERATIONS
Endo Operations Ltd has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. 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 |
|---|---|---|---|---|---|
| 40MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Nov 30, 2016 |
9. GRANULES
Granules Pharmaceuticals Inc has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Granules.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Sep 9, 2020 |
Manufacturing Plant Locations New
Granules'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 Granules as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||
| India |
| |||||||||||
10. IMPAX LABS INC
Impax Laboratories Inc has filed for 7 different strengths of generic version for Dexmethylphenidate Hydrochloride. 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 |
|---|---|---|---|---|---|
| 30MG | capsule, extended release | Prescription | ORAL | AB | Nov 21, 2013 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | May 19, 2014 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Aug 5, 2015 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Aug 5, 2015 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Dec 21, 2015 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Jul 5, 2017 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Jul 5, 2017 |
11. INTELLIPHARMACEUTICS
Intellipharmaceutics Corp has filed for 6 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Intellipharmaceutics.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG | capsule, extended release | Prescription | ORAL | AB | Nov 18, 2013 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Nov 18, 2013 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Nov 23, 2021 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Nov 23, 2021 |
| 40MG | capsule, extended release | Prescription | ORAL | AB | Nov 23, 2021 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Nov 23, 2021 |
Manufacturing Plant Locations New
Intellipharmaceutics'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 Intellipharmaceutics as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| Canada |
| |||
12. LANNETT CO INC
Lannett Co Inc has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Sep 25, 2017 |
| 2.5MG | tablet | Discontinued | ORAL | N/A | Sep 25, 2017 |
| 10MG | tablet | Discontinued | ORAL | N/A | Sep 25, 2017 |
13. NOVEL LABS INC
Novel Laboratories Inc has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
| 5MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
| 10MG | tablet | Prescription | ORAL | AB | Dec 4, 2015 |
14. RHODES PHARMS
Rhodes Pharmaceuticals Lp has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Rhodes Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet | Prescription | ORAL | AB | Nov 20, 2017 |
| 2.5MG | tablet | Prescription | ORAL | AB | Nov 20, 2017 |
| 5MG | tablet | Prescription | ORAL | AB | Nov 20, 2017 |
15. SUN PHARM INDS INC
Sun Pharmaceutical Industries Inc has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 35MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 40MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 20MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Nov 5, 2021 |
16. SUN PHARM INDUSTRIES
Sun Pharmaceutical Industries Inc has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 24, 2015 |
| 2.5MG | tablet | Prescription | ORAL | AB | Sep 24, 2015 |
| 10MG | tablet | Prescription | ORAL | AB | Sep 24, 2015 |
17. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. 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 |
|---|---|---|---|---|---|
| 2.5MG | tablet | Discontinued | ORAL | N/A | Jan 29, 2007 |
| 5MG | tablet | Discontinued | ORAL | N/A | Jan 29, 2007 |
| 10MG | tablet | Discontinued | ORAL | N/A | Jan 29, 2007 |
18. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 8 different strengths of generic version for Dexmethylphenidate Hydrochloride. 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 |
|---|---|---|---|---|---|
| 20MG | capsule, extended release | Prescription | ORAL | AB | Nov 19, 2013 |
| 5MG | capsule, extended release | Prescription | ORAL | AB | Nov 19, 2013 |
| 10MG | capsule, extended release | Prescription | ORAL | AB | Nov 19, 2013 |
| 40MG | capsule, extended release | Prescription | ORAL | AB | Nov 19, 2013 |
| 30MG | capsule, extended release | Prescription | ORAL | AB | May 19, 2014 |
| 15MG | capsule, extended release | Prescription | ORAL | AB | May 19, 2014 |
| 25MG | capsule, extended release | Prescription | ORAL | AB | Jul 5, 2017 |
| 35MG | capsule, extended release | Prescription | ORAL | AB | Jul 5, 2017 |
19. TRIS PHARMA INC
Tris Pharma Inc has filed for 3 different strengths of generic version for Dexmethylphenidate Hydrochloride. Given below are the details of the strengths of this generic introduced by Tris Pharma Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.5MG | tablet | Prescription | ORAL | AB | Aug 26, 2016 |
| 10MG | tablet | Prescription | ORAL | AB | Aug 26, 2016 |
| 5MG | tablet | Prescription | ORAL | AB | Aug 26, 2016 |
Manufacturing Plant Locations New
Tris Pharma Inc'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 Tris Pharma Inc as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||