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KEPPRA Drug Profile
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See Plans and PricingWhich patents cover Keppra, 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 three Paragraph IV challenges.
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. Seventy-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
US ANDA 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 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 68 |
| Patent Applications: | 2,341 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KEPPRA |
| Drug Sales Revenues: | Drug sales revenues for KEPPRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KEPPRA |
| DailyMed Link: | KEPPRA at DailyMed |
Recent Clinical Trials for KEPPRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Walter Reed National Military Medical Center | Phase 2 |
| Duke University | Phase 2 |
| Leiden University Medical Center | Phase 4 |
Recent Litigation for KEPPRA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc. | 2006-05-02 |
| In re: &039318 Patent Infringement Litigation | 2005-06-03 |
| In re: '318 Patent Infringement Litigation | 2005-06-03 |
Pharmacology for KEPPRA
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for KEPPRA
| (-)-(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide |
| (2S)-(2-Oxopyrrolidin-1-yl)butyramide |
| (2S)-2-(2-oxidanylidenepyrrolidin-1-yl)butanamide |
| (2S)-2-(2-oxo-1-pyrrolidinyl)butanamide |
| (2S)-2-(2-oxopyrrolidin-1-yl)butanamide |
| (ALPHAS)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE |
| (S)-(-)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide |
| (S)-2-(2-Oxo-1-pyrrolidinyl)butyramide |
| (S)-2-(2-OXO-PYRROLIDIN-1-YL)-BUTYRAMIDE |
| (s)-2-(2-oxopyrrolidin-1-yl) butyramide |
| (S)-2-(2-Oxopyrrolidin-1-yl)butanamide |
| (S)-2-(2-oxopyrrolidin-1-yl)butyramide |
| (S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide |
| (S)-Levetiracetam |
| 1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-, (alphaS)- |
| 1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-, (S)- |
| 102767-28-2 |
| 2(S)-(2-OXOPYRROLIDIN-1-YL)BUTYRAMIDE |
| 44YRR34555 |
| 767L282 |
| A800616 |
| AB0012613 |
| AB00639945_07 |
| AB00639945_08 |
| AB00639945-06 |
| AB13957 |
| AB2000064 |
| AC-1479 |
| AC1NR4PY |
| ACT02712 |
| AJ-26885 |
| AKOS015841981 |
| ALBB-027275 |
| AM20070676 |
| ANW-41693 |
| BC208262 |
| BCP11856 |
| BDBM50422542 |
| BIDD:GT0242 |
| BR-72955 |
| C07841 |
| CCG-100928 |
| CHEBI:6437 |
| CHEMBL1286 |
| CJ-24357 |
| CPD000466303 |
| CS-1854 |
| CTK3J2270 |
| D00709 |
| DB01202 |
| DTXSID9023207 |
| E Keppra |
| E keppra (TN) |
| Elepsia XR |
| Etiracetam levo-isomer |
| etiracetam, S-isomer |
| FT-0082600 |
| FT-0602577 |
| GTPL6826 |
| HMS2051D07 |
| HMS2089L20 |
| HMS2235I18 |
| HMS3262H11 |
| HMS3713P16 |
| HPHUVLMMVZITSG-LURJTMIESA-N |
| HSDB 7528 |
| HY-B0106 |
| KB-53189 |
| Keppra (TN) |
| Keppra XR |
| Keppra;Keppra XR |
| KS-00000ILW |
| KS-1176 |
| L-059 |
| L0234 |
| Levesam 500 |
| Levetiracetam |
| Levetiracetam (JAN/USAN/INN) |
| Levetiracetam [USAN:USP:INN:BAN] |
| Levetiracetam 1.0 mg/ml in Methanol |
| Levetiracetam In Sodium Chloride |
| Levetiracetam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Levetiracetam, >=98% (HPLC) |
| Levetiracetam, analytical standard |
| Levetiracetam, European Pharmacopoeia (EP) Reference Standard |
| Levetiracetam, United States Pharmacopeia (USP) Reference Standard |
| Levetiracetame |
| Levetiracetamum |
| Levetiracetamum [INN-Latin] |
| Levetiractam |
| Levipil |
| Leviteracetam |
| Levitiracetam, Pharmaceutical Secondary Standard; Certified Reference Material |
| Levroxa |
| LP00835 |
| LS-137054 |
| LS41261 |
| M-2814 |
| matever |
| MCULE-5120797917 |
| MFCD03265610 |
| MLS000759403 |
| MLS001424069 |
| MLS006010215 |
| MolPort-003-848-377 |
| NC00178 |
| NCGC00186028-01 |
| NCGC00261520-01 |
| NSC-760119 |
| NSC760119 |
| Pharmakon1600-01502265 |
| Q-201292 |
| RP23251 |
| RTC-063977 |
| s1356 |
| SAM001246539 |
| SC-15831 |
| SCHEMBL118843 |
| SIB-S1 |
| SMR000466303 |
| Spritam |
| SR-01000759400 |
| SR-01000759400-4 |
| SR-01000759400-5 |
| ST2408279 |
| STL388027 |
| SW197558-3 |
| TL8000131 |
| Torleva |
| Tox21_500835 |
| UCB 22059 |
| ucb L059 |
| ucb L060 |
| UCB-22059 |
| UCB-L 059 |
| UCB-L 059; Keppra |
| UCB-L059 |
| UNII-230447L0GL component HPHUVLMMVZITSG-LURJTMIESA-N |
| UNII-44YRR34555 |
| ZINC1547851 |
Paragraph IV (Patent) Challenges for KEPPRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KEPPRA | TABLET;ORAL | levetiracetam | 021035 | 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 | Start Trial | Start Trial | Start Trial | |||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-001 | Sep 12, 2008 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-002 | Feb 12, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | AA | 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 KEPPRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | Start Trial | Start Trial |
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872-001 | Jul 31, 2006 | Start Trial | Start Trial |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-004 | Jan 6, 2006 | Start Trial | Start Trial |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | Start Trial | Start Trial |
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KEPPRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 182375 | Start Trial |
| Poland | 1909764 | Start Trial |
| Taiwan | 200738280 | Start Trial |
| Croatia | P20141185 | Start Trial |
| Hong Kong | 1109071 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KEPPRA
| 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 |
