SPRITAM Drug Patent Profile
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When 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 three patents protecting this drug.
This drug has twenty patent family members in nine countries.
The generic ingredient in SPRITAM is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Spritam
A generic version of SPRITAM was approved as levetiracetam by MYLAN on November 4th, 2008.
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Summary for SPRITAM
| International Patents: | 20 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 132 |
| Patent Applications: | 3,215 |
| Drug Prices: | Drug price information for SPRITAM |
| What excipients (inactive ingredients) are in SPRITAM? | SPRITAM excipients list |
| DailyMed Link: | SPRITAM at DailyMed |
Pharmacology for SPRITAM
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for SPRITAM
SPRITAM is protected by five US patents.
Patents protecting SPRITAM
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Rapid disperse dosage form containing levetiracetam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING LEVETIRACETAM
Rapid disperse dosage form containing levetiracetam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING LEVETIRACETAM
Rapid disperse dosage form containing levetiracetam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS
Rapid disperse dosage form containing levetiracetam
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING LEVETIRACETAM UNDER FED CONDITIONS
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-001 | Jul 31, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-002 | Jul 31, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | 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 |
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 | 207958-001 | Jul 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-002 | Jul 31, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SPRITAM
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| UCB Pharma SA | Keppra | levetiracetam | EMEA/H/C/000277 Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. |
Authorised | no | no | no | 2000-09-29 | |
| Pfizer Europe MA EEIG | Levetiracetam Hospira | levetiracetam | EMEA/H/C/002783 Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible. |
Authorised | yes | no | no | 2014-01-07 | |
| Accord Healthcare S.L.U. | Levetiracetam Accord | levetiracetam | EMEA/H/C/002290 Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. |
Authorised | yes | no | no | 2011-10-03 | |
| Pharmathen S.A. | Matever | levetiracetam | EMEA/H/C/002024 Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. |
Authorised | yes | no | no | 2011-10-03 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SPRITAM
See the table below for patents covering SPRITAM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2017071626 | レベチラセタムを含む急速に分散する剤形 (RAPID DISPERSE DOSAGE FORM COMPRISING LEVETIRACETAM) | ⤷ Sign Up |
| Japan | 2001512488 | ⤷ Sign Up | |
| Japan | 2009215305 | DOSAGE FORM EXHIBITING RAPID DISPERSE PROPERTY, METHOD OF USE AND METHOD FOR PRODUCING THE SAME | ⤷ Sign Up |
| Spain | 2318869 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPRITAM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0162036 | C300028 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| 0162036 | 2000C/032 | Belgium | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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