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Levetiracetam - Generic Drug Details
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What are the generic sources for levetiracetam and what is the scope of levetiracetam freedom to operate?
Levetiracetam
is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, X Gen Pharms, Gland Pharma Ltd, Hq Speciality Pharma, Aci Healthcare Ltd, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Breckenridge Pharm, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Taro, Tolmar, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Dexcel Pharma, Eci Pharms Llc, Intellipharmaceutics, Lotus Pharm Co Ltd, Mylan Pharms Inc, Pharmadax Inc, Pharmtak Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm Industries, Sun Pharma Global, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Acic Pharms, Ajanta Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Secan Pharms, Torrent Pharms, Vintage Pharms, Watson Labs Inc, Wockhardt, and Zydus Pharms Usa Inc, and is included in ninety-one NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Levetiracetam has seventy-six patent family members in twenty-eight countries.
There are thirty-five drug master file entries for levetiracetam. Ninety-seven 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: | 91 |
| Drug Master File Entries: | 35 |
| Suppliers / Packagers: | 97 |
| Bulk Api Vendors: | 105 |
| Clinical Trials: | 174 |
| Patent Applications: | 3,425 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for levetiracetam |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for levetiracetam |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acic Pharms | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090767-002 | Jul 28, 2010 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Dr Reddys Labs Ltd | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 076920-001 | Jan 15, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Orit Labs Llc | LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 203067-001 | May 9, 2013 | AA | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Fosun Pharma | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 077324-002 | Jan 15, 2009 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Fosun Pharma | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 077324-001 | Jan 15, 2009 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Actavis Labs Fl Inc | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 077408-003 | Mar 2, 2009 | DISCN | 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 |
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Expired US Patents for levetiracetam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;IV (INFUSION) | 021872-001 | Jul 31, 2006 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | ➤ Sign Up | ➤ Sign Up |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-004 | Jan 6, 2006 | ➤ Sign Up | ➤ Sign Up |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | ➤ 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 |
|---|---|---|
| 7,863,316 | Extended release formulation of Levetiracetam | ➤ Sign Up |
| 9,114,072 | Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for levetiracetam
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | 2007009088 | ➤ Sign Up |
| Israel | 184822 | ➤ Sign Up |
| Slovenia | 1909764 | ➤ Sign Up |
| Canada | 2595988 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007012439 | ➤ Sign Up |
| Hong Kong | 1216513 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for levetiracetam
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00028 | Netherlands | ➤ Sign Up | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 |
| 00C/032 | Belgium | ➤ Sign Up | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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