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ELEPSIA XR Drug Profile
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When do Elepsia Xr patents expire, and what generic alternatives are available?
Elepsia Xr is a drug marketed by Sparc and is included in one NDA. There are five patents protecting this drug.
This drug has twenty-five patent family members in eighteen countries.
The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Elepsia Xr
A generic version of ELEPSIA XR was approved as levetiracetam by MYLAN on November 4th, 2008.
Summary for ELEPSIA XR
| International Patents: | 25 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Patent Applications: | 2,879 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ELEPSIA XR? | ELEPSIA XR excipients list |
| DailyMed Link: | ELEPSIA XR at DailyMed |
Pharmacology for ELEPSIA XR
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for ELEPSIA XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-001 | Dec 20, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-002 | Dec 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-001 | Dec 20, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-002 | Dec 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-001 | Dec 20, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ELEPSIA XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2403069 | Start Trial |
| South Korea | 20060076307 | Start Trial |
| Denmark | 1663175 | Start Trial |
| Australia | 2011200881 | Start Trial |
| Brazil | PI0414305 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ELEPSIA XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0162036 | C300028 | Netherlands | Start Trial | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| 0162036 | 2000C/032 | Belgium | Start Trial | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
