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Levetiracetam - Generic Drug Details
What are the generic drug 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, Oxford Pharms, 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-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: | 66 |
| NDAs: | 91 |
| Drug Master File Entries: | 35 |
| Suppliers / Packagers: | 98 |
| Bulk Api Vendors: | 107 |
| Clinical Trials: | 182 |
| 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 |
Tentative approvals for LEVETIRACETAM
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 500MG | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 1GM | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 750MG | TABLET;ORAL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 091399-002 | Sep 12, 2011 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Lotus Pharm Co Ltd | LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 202095-002 | Jun 6, 2016 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Hetero Labs Ltd Iii | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090515-001 | Oct 8, 2010 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Aci Healthcare Ltd | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078042-001 | Jan 15, 2009 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 levetiracetam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-001 | Jul 31, 2015 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;IV (INFUSION) | 021872-001 | Jul 31, 2006 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-003 | Jul 31, 2015 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for levetiracetam
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 5183470 | ➤ Try a Free Trial |
| Israel | 182375 | ➤ Try a Free Trial |
| Japan | 2001512488 | ➤ Try a Free Trial |
| Spain | 2524771 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for levetiracetam
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00C/032 | Belgium | ➤ Try a Free Trial | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 |
| 00028 | Netherlands | ➤ Try a Free Trial | 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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