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Author: Admin | 2025-04-28
HomeConcertaGeneric Availability Last updated on Jan 8, 2025.Concerta is a brand name of methylphenidate, approved by the FDA in the following formulation(s):CONCERTA (methylphenidate hydrochloride - tablet, extended release;oral) Manufacturer: JANSSEN PHARMS Approval date: August 1, 2000 Strength(s): 18MG [RLD] [AB], 36MG [RLD] [AB] Manufacturer: JANSSEN PHARMS Approval date: December 8, 2000 Strength(s): 54MG [RLD] [AB] Manufacturer: JANSSEN PHARMS Approval date: April 1, 2002 Strength(s): 27MG [RLD] [AB] Has a generic version of Concerta been approved?Yes. The following products are equivalent to Concerta:methylphenidate hydrochloride tablet, extended release;oral Manufacturer: ACTAVIS LABS FL Approval date: March 21, 2018 Strength(s): 54MG [AB] Manufacturer: ACTAVIS LABS FL Approval date: March 22, 2018 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB] Manufacturer: ALKEM LABS LTD Approval date: May 23, 2023 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Manufacturer: ANDOR PHARMS Approval date: April 24, 2019 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Manufacturer: ASCENT PHARMS INC Approval date: September 3, 2019 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Manufacturer: AUROLIFE PHARMA LLC Approval date: October 21, 2016 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Manufacturer: DR REDDYS Approval date: July 29, 2020 Strength(s): 36MG [AB], 54MG [AB], 18MG [AB], 27MG [AB] Manufacturer: OSMOTICA PHARM US Approval date: July 28, 2017 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Manufacturer: SUN PHARM INDS INC Approval date: August 19, 2020 Strength(s): 18MG [AB], 27MG [AB], 36MG [AB], 54MG [AB] Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Concerta. 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. 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
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