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Levetiracetam - Generic Drug Details
What are the generic sources for levetiracetam and what is the scope of levetiracetam freedom to operate?
Levetiracetam has seventy-six patent family members in twenty-eight countries.
There are thirty-five drug master file entries for levetiracetam. Seventy-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for levetiracetam
| International Patents: | 76 |
| US Patents: | 6 |
| Tradenames: | 6 |
| Applicants: | 65 |
| NDAs: | 90 |
| Drug Master File Entries: | 35 |
| Suppliers / Packagers: | 78 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 174 |
| Patent Applications: | 3,364 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | levetiracetam at DailyMed |
Pharmacology for levetiracetam
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for levetiracetam
| (-)-(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide |
| (-)-Levetiracetam |
| (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, A-ETHYL-2-OXO-, (AS)- |
| 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 |
| AK-72955 |
| AKOS015841981 |
| ALBB-027275 |
| AM20070676 |
| ANW-41693 |
| BC208262 |
| BDBM50422542 |
| BIDD:GT0242 |
| BR-72955 |
| C07841 |
| CCG-100928 |
| CHEBI:6437 |
| CHEMBL1286 |
| CJ-24357 |
| CPD000466303 |
| CS-1854 |
| CTK3J2270 |
| D00709 |
| D01XRM |
| D0E1XL |
| DB01202 |
| DTXSID9023207 |
| E Keppra |
| E keppra (TN) |
| Elepsia XR |
| Etiracetam levo-isomer |
| etiracetam, S-isomer |
| FT-0082600 |
| FT-0602577 |
| GTPL6826 |
| HE290875 |
| HMS2051D07 |
| HMS2089L20 |
| HMS2235I18 |
| HMS3262H11 |
| HPHUVLMMVZITSG-LURJTMIESA-N |
| HSDB 7528 |
| HY-B0106 |
| KB-53189 |
| Keppra |
| Keppra (TN) |
| Keppra XR |
| Keppra, Keppra XR),Levetiracetam |
| Keppra;Keppra XR |
| KS-00000ILW |
| KS-1176 |
| L-059 |
| L0234 |
| Levesam 500 |
| Levetiracetam (JAN/USAN/INN) |
| Levetiracetam [INN] |
| Levetiracetam [USAN:USP:INN:BAN] |
| Levetiracetam 1.0 mg/ml in Methanol |
| Levetiracetam In Sodium Chloride |
| 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 |
| Levetriacetam |
| Levipil |
| Leviteracetam |
| Levitiracetam, pharmaceutical secondary standard; traceable to USP, PhEu |
| 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 |
| RTECS VJ0000000 |
| s1356 |
| SAM001246539 |
| SBB070161 |
| SC-15831 |
| SCHEMBL118843 |
| SIB-S1 |
| SMR000466303 |
| Spritam |
| ST2408279 |
| STL388027 |
| TL8000131 |
| Torleva |
| Tox21_500835 |
| UCB 22059 |
| UCB L-059 |
| ucb L059 |
| ucb L060 |
| UCB-22059 |
| UCB-L 059 |
| UCB-L059 |
| UNII-230447L0GL component HPHUVLMMVZITSG-LURJTMIESA-N |
| UNII-44YRR34555 |
| ZINC1547851 |
US Patents and Regulatory Information for levetiracetam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 201293-003 | Jun 14, 2011 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Orchid Hlthcare | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090484-001 | Aug 5, 2010 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Apotex Inc | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078869-003 | Mar 13, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 levetiracetam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for levetiracetam
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,114,072 | Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same | ➤ Sign Up |
| 7,863,316 | Extended release formulation of Levetiracetam | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for levetiracetam
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9836738 | ➤ Sign Up |
| Mexico | 2007009088 | ➤ Sign Up |
| Peru | 02652010 | ➤ Sign Up |
| Japan | 2008528571 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for levetiracetam
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00C/032 | Belgium | ➤ Sign Up | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| 00028 | Netherlands | ➤ Sign Up | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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