Methylphenidate Patent Expiration

Methylphenidate is Used for treating Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients. It was first introduced by Noven Pharmaceuticals Inc in its drug Daytrana on Apr 6, 2006. Another drug containing Methylphenidate is Cotempla Xr-Odt. 4 different companies have introduced drugs containing Methylphenidate.


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 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
Cotempla Xr-odt US8840924 Compositions and methods of making rapidly dissolving ionically masked formulations Jun 05, 2026 Neos Theraps 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
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 US5958446 Solubility parameter based drug delivery system and method for altering drug saturation concentration Dec 12, 2012

(Expired)

Noven Pharms Inc



Methylphenidate's Family Patents

Family Patents

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Methylphenidate Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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


Manufacturing Plant Locations
New

Actavis Elizabeth'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 Actavis Elizabeth as present at those locations.

Country City Firm Name
United States
Elizabeth Actavis Elizabeth LLC, A Company of Teva





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
20MG/9HR (2.2MG/HR)

film, extended release Prescription TRANSDERMAL AB Mar 14, 2022
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