DrugPatentWatch Database Preview
APTIOM Drug Profile
Which patents cover Aptiom, and when can generic versions of Aptiom launch?
Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for APTIOM
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 54 |
| Clinical Trials: | 3 |
| Patent Applications: | 48 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APTIOM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APTIOM |
| DailyMed Link: | APTIOM at DailyMed |
Generic Entry Opportunity Date for APTIOM
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for APTIOM
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for APTIOM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for APTIOM
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg, 400 mg, 600 mg and 800 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for APTIOM
Supplementary Protection Certificates for APTIOM
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00406 | Netherlands | ➤ Sign Up | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
| 2009 00023 | Denmark | ➤ Sign Up | |
| 0 | Finland | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
