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 thirty patent family members in twenty-six countries.
The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-one 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: | 30 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 115 |
| Patent Applications: | 3,016 |
| 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 |
| CureRareDisease LLC | Phase 1/Phase 2 |
| Myrtelle Inc. | Phase 1/Phase 2 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-001 | Sep 12, 2008 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-002 | Feb 12, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | AA | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-004 | Jan 6, 2006 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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 | 021035-003 | Nov 30, 1999 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872-001 | Jul 31, 2006 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-004 | Jan 6, 2006 | See Plans and Pricing | See Plans and Pricing |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KEPPRA
See the table below for patents covering KEPPRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 212985 | See Plans and Pricing | |
| Georgia, Republic of | P20002001 | (S)-alfa-ethyl-2-oxo-1-pyrolidinacetamide | See Plans and Pricing |
| South Korea | 920003819 | See Plans and Pricing | |
| Australia | 4252985 | See Plans and Pricing | |
| Poland | 253374 | See Plans and Pricing | |
| Spain | 8703419 | See Plans and Pricing | |
| New Zealand | 554157 | Pharmaceutical compositions comprising levetiracetam and process for their preparation | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KEPPRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0162036 | C300028 | Netherlands | See Plans and Pricing | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| 0162036 | SPC/GB00/030 | United Kingdom | See Plans and Pricing | SPC/GB00/030: 20050514, EXPIRES: 20100514 |
| 0162036 | 2000C/032 | Belgium | See Plans and Pricing | 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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