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Generic Aptiom Availability

Aptiom is a brand name of eslicarbazepine, approved by the FDA in the following formulation(s):

APTIOM (eslicarbazepine acetate - tablet;oral)

  • Manufacturer: SUNOVION PHARMS INC
    Approval date: November 8, 2013
    Strength(s): 200MG, 400MG, 600MG, 800MG [RLD]

Has a generic version of Aptiom been approved?

No. There is currently no therapeutically equivalent version of Aptiom available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Aptiom. 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: About generic drugs.

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.

  • Substituted dihydrodibenzo/b,f/azepines, method of their preparation, their use in the treatment of some central nervous system disorders, and pharmaceutical compositions containing them
    Patent 5,753,646
    Issued: May 19, 1998
    Inventor(s): Benes; Jan & Soares Da Silva; Patricio M. V. A.
    Assignee(s): Portela & Ca., S.A.
    New compounds of general formula I, including all possible stereoisomers, are described ##STR1## wherein: R is hydrogen, alkyl, aminoalkyl, halogenalkyl, aralkyl, cycloalkyl, cycloalkylalkyl, alkoxy, phenyl or substituted phenyl or pyridyl group. A process for their preparation consists of reaction of compound II ##STR2## with an acylating agent.
    Patent expiration dates:
    • June 27, 2017
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      Patent use: METHOD OF TREATING EPILEPSY
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      Drug substance
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      Drug product
    • June 27, 2017
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      Patent use: APPROVED INDICATIONS: APTIOM (ESLICARBAZEPINE ACETATE) IS INDICATED AS ADJUNCTIVE TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY. PATENT CLAIMS: IN A METHOD OF TREATING A SUBJECT AFFLICTED WITH EPILEPSY
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      Drug substance
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      Drug product
    • June 27, 2017
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      Patent use: MONOTHERAPY OR ADJUNCTIVE THERAPY FOR TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY
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      Drug substance
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      Drug product
  • Pharmaceutical composition comprising licarbazepine acetate
    Patent 8,372,431
    Issued: February 12, 2013
    Assignee(s): BIAL-Portela & C.A., S.A.
    A pharmaceutical composition comprising licarbazepine acetate, especially eslicarbazepine acetate, in combination with suitable excipients, in particular a binder, and a disintegrant. Also disclosed is a granulation process, especially a wet granulation process, for making the pharmaceutical composition.
    Patent expiration dates:
    • April 17, 2030
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      Drug product
  • Asymmetric catalytic reduction of oxcarbazepine
    Patent 9,206,135
    Issued: December 8, 2015
    Assignee(s): Bial-Portela & CA, S.A.
    A process for preparing (S)-(+)-10,11-dihydro-10-hydroxy-5H-dibenz/b,f/azepine-5-carboxamide or (R)-(−)-10,11-dihydro-10-hydroxy-5H-dibenz/b,f/azepine-5-carboxamide, by reduction of oxcarbazepine in the presence of a catalyst and a hydride source is disclosed. The catalyst is prepared from a combination of [RuX2(L)]2 wherein X is chlorine, bromine or iodine, and L is an aryl or aryl-aliphatic ligand, with a ligand of formula (A) or formula (B): wherein R1 is chosen from C1-6 alkoxy and C1-6 alkyl, n is a number from 0 to 5, and when n is a number from 2 to 5, R1 can be the same or different, and R2 is alkyl, substituted alkyl, aryl, substituted aryl, alkaryl or substituted alkaryl. The hydride source is either NR3R4R5 and formic acid, [R3R4R5NH][OOCH] and optionally formic acid, or [M][OOCH]x and formic acid, wherein R3, R4 and R5 are C1-6 alkyl, M is an alkali metal or alkaline earth metal and x is 1 or 2. A pH from 6.5 to 8 is maintained during the process.
    Patent expiration dates:
    • April 21, 2026
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      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 27, 2018 - FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET SEIZURES IN ADULTS.
    • August 27, 2018 - 1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE
    • November 8, 2018 - NEW CHEMICAL ENTITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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