DrugPatentWatch Database Preview
KEPPRA Drug Profile
Which 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 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-two suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for KEPPRA
| International Patents: | 29 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 4 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 68 |
| Patent Applications: | 2,301 |
| 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 |
| Erasmus 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: '318 Patent Infringement Litigation | 2005-06-03 |
| UCB Societe Anonyme v. Mylan Laboratories |
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 | ||
| >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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KEPPRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007012439 | Start Trial |
| Peru | 02652010 | Start Trial |
| Japan | 5183470 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KEPPRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0162036 | 2000C/032 | Belgium | Start Trial | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| 0162036 | C300028 | Netherlands | Start Trial | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
