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SPRITAM Drug Profile
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» See Plans and PricingWhen do Spritam patents expire, and when can generic versions of Spritam launch?
Spritam is a drug marketed by Aprecia Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has eighteen patent family members in nine countries.
The generic ingredient in SPRITAM is levetiracetam. There are thirty-five drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
US ANDA Litigation and Generic Entry Outlook for Spritam
A generic version of SPRITAM was approved as levetiracetam by MYLAN on November 4th, 2008.
Summary for SPRITAM
| International Patents: | 18 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 110 |
| Patent Applications: | 2,341 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SPRITAM |
| DailyMed Link: | SPRITAM at DailyMed |
Pharmacology for SPRITAM
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for SPRITAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SPRITAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-002 | Jul 31, 2015 | Start Trial | Start Trial |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | Start Trial | Start Trial |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-002 | Jul 31, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPRITAM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2906029 | Start Trial |
| Japan | 2016514680 | Start Trial |
| Mexico | 365513 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPRITAM
| 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 |
