Generic Aptiom Availability
Last updated on Apr 10, 2025.
Aptiom is a brand name of eslicarbazepine, approved by the FDA in the following formulation(s):
APTIOM (eslicarbazepine acetate - tablet;oral)
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Manufacturer: SUMITOMO PHARMA AM
Approval date: November 8, 2013
Strength(s): 200MG [RLD] [AB], 400MG [RLD] [AB], 600MG [RLD] [AB], 800MG [RLD] [AB]
Is there a generic version of Aptiom available?
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
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Manufacturer: ALKEM LABS LTD
Approval date: October 6, 2023
Strength(s): 200MG [AB], 400MG [AB], 600MG [AB], 800MG [AB] -
Manufacturer: DR REDDYS
Approval date: June 29, 2021
Strength(s): 200MG [AB], 400MG [AB], 600MG [AB], 800MG [AB] -
Manufacturer: HETERO LABS LTD V
Approval date: August 3, 2023
Strength(s): 200MG [AB], 400MG [AB], 600MG [AB], 800MG [AB] -
Manufacturer: LUPIN LTD
Approval date: March 27, 2024
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.
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Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent 10,675,287
Issued: June 9, 2020
Inventor(s): de Almeida José Luís & Soares da Silva Patrício Manuel Vieira Araújo
Assignee(s): Bial-Portela & CA S.A.The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.
Patent expiration dates:
- May 6, 2025✓
- May 6, 2025✓
- May 6, 2025
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Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent 10,695,354
Issued: June 30, 2020
Inventor(s): de Almeida José Luís & Soares da Silva Patrício Manuel Vieira Araújo
Assignee(s): Bial-Portela & CA S.A.The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.
Patent expiration dates:
- May 6, 2025✓
- May 6, 2025✓
- May 6, 2025
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Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent 10,702,536
Issued: July 7, 2020
Inventor(s): de Almeida José Luis & Soares da Silva Patrício Manuel Vieira Araújo
Assignee(s): BIAL-PORTELA & CA S.A.The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.
Patent expiration dates:
- May 6, 2025✓
- May 6, 2025
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Pharmaceutical composition comprising licarbazepine acetate
Patent 10,912,781
Issued: February 9, 2021
Inventor(s): Cardoso de Vasconcelos Teöfilo & dos Santos Lima Ricardo Jorge & Cerdeira de Campos Costa Rui
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:
- October 23, 2028✓
- October 23, 2028
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Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent 11,364,247
Issued: June 21, 2022
Inventor(s): de Almeida; José Luís et al.
Assignee(s): BIAL-PORTELA & CA S.A. (S. Mamede Do Coronado, PT)The present disclosure relates to the treatment of various diseases and conditions with eslicarbazepine acetate. The present disclosure also relates to the use of eslicarbazepine acetate in a method for reducing or decreasing epileptic seizures in a patient. The present disclosure also relates to a method for increasing the exposure to eslicarbazepine in a patient. The present disclosure also relates to a method of preparing a pharmaceutical composition comprising eslicarbazepine acetate.
Patent expiration dates:
- May 6, 2025✓
- May 6, 2025✓
- May 6, 2025
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Pharmaceutical composition comprising licarbazepine acetate
Patent 8,372,431
Issued: February 12, 2013
Inventor(s): Cardoso de Vasconcelos Teófilo & dos Santos Lima Ricardo Jorge & Cerdeira de Campos Costa Rui
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✓
- April 17, 2030
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Asymmetric catalytic reduction of oxcarbazepine
Patent 9,206,135
Issued: December 8, 2015
Inventor(s): Learmonth David Alexander & Grasa Gabriela Alexandra & Zanotti-Gerosa Antonio
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 [RuX(L)]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):
Patent expiration dates:
- April 21, 2026✓
- April 21, 2026
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Pharmaceutical composition comprising licarbazepine acetate
Patent 9,566,244
Issued: February 14, 2017
Inventor(s): Cardoso de Vasconcelos Teófilo & dos Santos Lima Ricardo Jorge & Cerdeira de Campos Costa Rui
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✓
- October 23, 2028
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Asymmetric catalytic reduction of oxcarbazepine
Patent 9,643,929
Issued: May 9, 2017
Inventor(s): Learmonth David Alexander & Grasa Gabriela Alexandra & Zanotti-Gerosa Antonio
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 [RuX(L)]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):
Patent expiration dates:
- April 21, 2026✓
- April 21, 2026
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Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent 9,750,747
Issued: September 5, 2017
Inventor(s): Soares Da Silva Patricio Manuel Vieira Araujo
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✓
- August 24, 2032✓
- August 24, 2032
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Therapeutical uses of eslicarbazepine
Patent 9,763,954
Issued: September 19, 2017
Inventor(s): Soares Da Silva Patricio Manuel Vieira Araújo
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✓
- September 13, 2028
More about Aptiom (eslicarbazepine)
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- Drug class: dibenzazepine anticonvulsants
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Patient resources
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Glossary
Term | Definition |
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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.