Drug
Who makes eslicarbazepine acetate?
10 companies list eslicarbazepine acetate as a human prescription drug, including under the names Aptiom. Forms: kit; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing eslicarbazepine acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sumitomo Pharma Co., Ltd.Japan | kit; tablet | NDANDA022416 | 5 | 2 |
| Lupin LimitedIndia | tablet | ANDAANDA211246 | 4 | 14 |
| Apotex Inc.Canada | tablet | ANDAANDA211236 | 4 | 6 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA216481 | 4 | 6 |
| Torrent Pharma, Inc.India | tablet | ANDAANDA211227 | 4 | 5 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA211186 | 4 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA211236 | 4 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA211199 | 4 | 0 |
| Dr. Reddys Laboratories Limited | tablet | ANDAANDA211238 | 4 | 0 |
| Jubilant Cadista Pharmaceuticals Inc. | tablet | ANDAANDA211219 | 4 | 0 |
Bulk ingredient listings
- Hubei Gedian Humanwell Pharmaceutical Co., LtdChina · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd. · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Lupin LimitedIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
5 unexpired patents list eslicarbazepine acetate as the active ingredient, expiring between Sept 2028 and Aug 2032. Application holder: SUMITOMO PHARMA AMERICA INC.
Enquiry
Common questions
- Who makes eslicarbazepine acetate?
- 10 companies list eslicarbazepine acetate as a human prescription drug in the openFDA NDC Directory, led by Sumitomo Pharma Co., Ltd., Lupin Limited, Apotex Inc., Aurobindo Pharma Limited, Torrent Pharma, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Aptiom?
- 9 companies list eslicarbazepine acetate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies eslicarbazepine acetate active ingredient?
- 11 companies list eslicarbazepine acetate as a bulk ingredient, including Hubei Gedian Humanwell Pharmaceutical Co., Ltd, Aurobindo Pharma Limited, CTX Lifesciences Pvt. Ltd., Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd..