DrugPatentWatch Database Preview
APTIOM Drug Profile
see a sample report or, see our see our flat-rate plans
When do Aptiom patents expire, and what generic alternatives are available?
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.
This drug has one hundred and seventeen patent family members in thirty countries.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are eleven 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
| International Patents: | 117 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 51 |
| 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
Generic Entry Date for APTIOM*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
see a sample report or, see our see our flat-rate plans
Paragraph IV (Patent) Challenges for APTIOM
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg, 400 mg, 600 mg and 800 mg | ➤ Subscribe | ➤ Try a Free Trial |
Non-Orange Book US Patents for APTIOM
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,288,532 | Asymmetric catalytic reduction of oxcarbazepine | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
see a sample report or, see our see our flat-rate plans
International Patents for APTIOM
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 20170004034 | ➤ Try a Free Trial |
| Spain | 2606952 | ➤ Try a Free Trial |
| European Patent Office | 2319836 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for APTIOM
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB09/047 | United Kingdom | ➤ Try a Free Trial | PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421 |
| 2009 00023 | Denmark | ➤ Try a Free Trial | |
| 00406 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
