Methylphenidate Patent Expiration
Methylphenidate is Used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients. It was first introduced by Noven Pharmaceuticals Inc
Methylphenidate Patents
Given below is the list of patents protecting Methylphenidate, 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 |
|---|---|---|---|---|
| Cotempla Xr-odt | US11166947 | Effective dosing of a child for the treatment of ADHD with methylphenidate | Jan 25, 2038 | Neos Theraps Inc |
| Cotempla Xr-odt | US8840924 | Compositions and methods of making rapidly dissolving ionically masked formulations | Jun 05, 2026 | Neos Theraps Inc |
| Cotempla Xr-odt | US9072680 | Compositions comprising methylphenidate complexed with ion-exchange resin particles | Jun 28, 2032 | Neos Theraps Inc |
| Cotempla Xr-odt | US9089496 | Compositions comprising methylphenidate complexed with ion-exchange resin particles | Jun 28, 2032 | Neos Theraps Inc |
| Daytrana | US5958446 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec 12, 2012
(Expired) | Noven Pharms Inc |
| Daytrana | US6210705 | Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate |
Sep 30, 2018
(Expired) | Noven Pharms Inc |
| Daytrana | US6348211 | Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate |
Sep 30, 2018
(Expired) | Noven Pharms Inc |
| Daytrana | US8632802 | Device for transdermal administration of drugs including acrylic polymers | Oct 07, 2025 | Noven Pharms Inc |
| Daytrana | US9034370 | Device for transdermal administration of drugs including acrylic polymers | Oct 07, 2025 | Noven Pharms Inc |
| Daytrana | US9668981 | Device for transdermal administration of drugs including acrylic based polymers | Oct 07, 2025 | Noven Pharms Inc |
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Methylphenidate Generics
Several generic applications have been filed for Methylphenidate. The first generic version for Methylphenidate was by Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jun 19, 2020. And the latest generic version is by Mylan Technologies Inc A Viatris Co and was approved on Mar 14, 2022.
Given below is the list of companies who have filed for Methylphenidate generic.
1. ACTAVIS ELIZABETH
Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Methylphenidate. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25.9MG | tablet, orally disintegrating, extended release | Discontinued | ORAL | N/A | Jun 19, 2020 |
| 8.6MG | tablet, orally disintegrating, extended release | Discontinued | ORAL | N/A | Jun 19, 2020 |
| 17.3MG | tablet, orally disintegrating, extended release | Discontinued | ORAL | N/A | Jun 19, 2020 |
2. MYLAN TECH VIATRIS
Mylan Technologies Inc A Viatris Co has filed for 4 different strengths of generic version for Methylphenidate. Given below are the details of the strengths of this generic introduced by Mylan Tech Viatris.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/9HR (3.3MG/HR) | film, extended release | Prescription | TRANSDERMAL | AB | Mar 14, 2022 |
| 10MG/9HR (1.1MG/HR) | film, extended release | Prescription | TRANSDERMAL | AB | Mar 14, 2022 |
| 15MG/9HR (1.6MG/HR) | film, extended release | Prescription | TRANSDERMAL | AB | Mar 14, 2022 |
| 20MG/9HR (2.2MG/HR) | film, extended release | Prescription | TRANSDERMAL | AB | Mar 14, 2022 |