KEPPRA Drug Patent Profile
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When do Keppra patents expire, and when can generic versions of Keppra launch?
Keppra is a drug marketed by Ucb Inc and is included in four NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-nine patent family members in twenty-five countries.
The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Keppra
A generic version of KEPPRA was approved as levetiracetam by MYLAN on November 4th, 2008.
Summary for KEPPRA
| International Patents: | 29 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 116 |
| Patent Applications: | 3,334 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KEPPRA |
| Drug Sales Revenues: | Drug sales revenues for KEPPRA |
| What excipients (inactive ingredients) are in KEPPRA? | KEPPRA excipients list |
| DailyMed Link: | KEPPRA at DailyMed |
Recent Clinical Trials for KEPPRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sohag University | Phase 2 |
| Myrtelle Inc. | Phase 1/Phase 2 |
| CureRareDisease LLC | Phase 1/Phase 2 |
Pharmacology for KEPPRA
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for KEPPRA
Paragraph IV (Patent) Challenges for KEPPRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KEPPRA | Tablets | levetiracetam | 1000 mg | 021035 | 1 | 2007-01-24 |
US Patents and Regulatory Information for KEPPRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872-001 | Jul 31, 2006 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-001 | Sep 12, 2008 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-002 | Feb 12, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 KEPPRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872-001 | Jul 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for KEPPRA
| 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 | |
| Actavis Group PTC ehf | Levetiracetam Actavis | levetiracetam | EMEA/H/C/002355 Levetiracetam Actavis 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 Actavis 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 KEPPRA
See the table below for patents covering KEPPRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 80673 | ⤷ Try a Trial | |
| Bulgaria | 60030 | METHOD FOR THE PREPARATION OF /D/-ETHYL-2-OXO-1-PIRROLIDINEACETAMIDE | ⤷ Try a Trial |
| Israel | 75179 | (S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE,ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT | ⤷ Try a Trial |
| Spain | 8704893 | PROCEDIMIENTO PARA PREPARAR (S)-ALFA-ETIL-2-OXO-1-PIRROLIDINACETAMIDA ((S)-alpha-ethyl-2-oxo-1-pyrrolidinacetamide.) | ⤷ Try a Trial |
| Mexico | 2007004294 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN LEVETIRACETAM Y PROCESO PARA SU PREPARACION. (PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KEPPRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0162036 | 2000C/032 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| 0162036 | C300028 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| 0162036 | SPC/GB00/030 | United Kingdom | ⤷ Try a Trial | SPC/GB00/030: 20050514, EXPIRES: 20100514 |
| >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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Privacy and Cookies
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DrugPatentWatch Alternatives
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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