Generic Cotempla XR-ODT Availability
Last updated on Apr 10, 2025.
Cotempla XR-ODT is a brand name of methylphenidate, approved by the FDA in the following formulation(s):
COTEMPLA XR-ODT (methylphenidate - tablet, orally disintegrating, extended release;oral)
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Manufacturer: NEOS THERAPS INC
Approval date: June 19, 2017
Strength(s): 8.6MG [RLD], 17.3MG [RLD], 25.9MG [RLD] -
Manufacturer: NEOS THERAPS INC
Approval date: August 19, 2024
Strength(s): 34.6MG (discontinued) [RLD]
Is there a generic version of Cotempla XR-ODT available?
No. There is currently no therapeutically equivalent version of Cotempla XR-ODT available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cotempla XR-ODT. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Effective dosing of a child for the treatment of ADHD with methylphenidate
Patent 11,166,947
Issued: November 9, 2021
Inventor(s): Tengler Mark & Teuscher Nathan
Assignee(s): Neos Therapeutics, LPThe present invention generally relates to treating attention-deficit disorders (e.g., ADHD) by providing an effective amount of an ADHD-effective agent to a patient in need thereof (e.g., a child).
Patent expiration dates:
- January 25, 2038✓
- January 25, 2038
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Compositions and methods of making rapidly dissolving ionically masked formulations
Patent 8,840,924
Issued: September 23, 2014
Inventor(s): Tengler Mark & McMahen Russell
Assignee(s): NEOS Therapeutics, LPThe present invention includes compositions and methods for reduce the taste of the drug in the drug resin complex. The composition may include one or more drug-resin complexes and a highly compressible, free-flowing pharmaceutical excipient. The resin is present in an amount effective to reduce the taste of the drug in the drug resin complex relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient causes release of the drug-resin complex in the mouth.
Patent expiration dates:
- June 5, 2026✓
- June 5, 2026
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Compositions comprising methylphenidate complexed with ion-exchange resin particles
Patent 9,072,680
Issued: July 7, 2015
Inventor(s): Tengler Mark & McMahen Russell
Assignee(s): NEOS THERAPEUTICS, LLPPharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating. Preferably, the second plurality of drug-resin particles are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating.
Patent expiration dates:
- June 28, 2032✓
- June 28, 2032
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Compositions comprising methylphenidate complexed with ion-exchange resin particles
Patent 9,089,496
Issued: July 28, 2015
Inventor(s): Tengler Mark & McMahen Russell
Assignee(s): NEOS THERAPEUTICS, LPPharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating.
Patent expiration dates:
- June 28, 2032✓
- June 28, 2032
More about Cotempla XR-ODT (methylphenidate)
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- Drug class: CNS stimulants
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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