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Generic Aptiom Availability

Last updated on July 7, 2021.

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

APTIOM (eslicarbazepine acetate - tablet;oral)

Has a generic version of Aptiom been approved?

A generic version of Aptiom has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Aptiom and have been approved by the FDA:

eslicarbazepine acetate tablet;oral

  • Manufacturer: DR REDDYS LABS LTD
    Approval date: June 29, 2021
    Strength(s): 200MG [AB], 400MG [AB], 600MG [AB], 800MG [AB]

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: 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.

  • Patent 10,675,287

    Patent expiration dates:

    • May 6, 2025
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
    • May 6, 2025
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES
  • Patent 10,695,354

    Patent expiration dates:

    • May 6, 2025
      ✓ 
      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
    • May 6, 2025
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES
  • Patent 10,702,536

    Patent expiration dates:

    • May 6, 2025
      ✓ 
      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES
  • Patent 10,912,781

    Patent expiration dates:

    • October 23, 2028
      ✓ 
      Drug product
  • 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, 2021
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES
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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
      ✓ 
      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
  • Pharmaceutical composition comprising licarbazepine acetate
    Patent 9,566,244
    Issued: February 14, 2017
    Assignee(s): BIAL-PORTELE & CA, 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:

    • October 23, 2028
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      Drug product
  • Asymmetric catalytic reduction of oxcarbazepine
    Patent 9,643,929
    Issued: May 9, 2017
    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 product
  • Treatments involving eslicarbazepine acetate or eslicarbazepine
    Patent 9,750,747
    Issued: September 5, 2017
    Assignee(s): BAIL-PORTELA & CA, S.A.

    The invention provides a drug selected from eslicarbazepine acetate and eslicarbazepine, for use in treating or preventing a disorder selected from epilepsy, affective disorders, schizoaffective disorders, bipolar disorders, neuropathic pain and neuropathic pain related disorders, attention disorders, anxiety disorders, sensorimotor disorders, vestibular disorders, and fibromyalgia, in a patient suffering from or susceptible to absence seizures.

    Patent expiration dates:

    • August 24, 2032
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES
    • August 24, 2032
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES
  • Therapeutical uses of eslicarbazepine
    Patent 9,763,954
    Issued: September 19, 2017
    Assignee(s): BIAL—PORTELA & CA, S.A.

    New applications of eslicarbazepine and eslicarbazepine acetate in the treatment of intractable conditions.

    Patent expiration dates:

    • September 13, 2028
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      Patent use: TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.