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Levetiracetam - Generic Drug Details
What are the generic sources for levetiracetam and what is the scope of freedom to operate?
Levetiracetam
is the generic ingredient in seven branded drugs marketed by Ucb Inc, Akorn, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, 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, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Sparc, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Dexcel Pharma, Eci Pharms Llc, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Acic Pharms, Aurobindo Pharma, Breckenridge Pharm, Chartwell Rx, 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-three NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Levetiracetam has ninety patent family members in thirty countries.
There are thirty-five drug master file entries for levetiracetam. Eighty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for levetiracetam
| International Patents: | 90 |
| US Patents: | 9 |
| Tradenames: | 7 |
| Applicants: | 68 |
| NDAs: | 93 |
| Drug Master File Entries: | 35 |
| Suppliers / Packagers: | 83 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 186 |
| Patent Applications: | 3,787 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for levetiracetam |
| Drug Sales Revenues: | Drug sales revenues for levetiracetam |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for levetiracetam |
| DailyMed Link: | levetiracetam at DailyMed |
Recent Clinical Trials for levetiracetam
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Walter Reed National Military Medical Center | Phase 2 |
| Beth Israel Deaconess Medical Center | Phase 2 |
| Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Phase 3 |
Recent Litigation for levetiracetam
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| PAR PHARMACEUTICAL, INC. v. UCB, INC. | 2011-03-23 |
| Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc. | 2006-05-02 |
| In re: '318 Patent Infringement Litigation | 2005-06-03 |
Generic filers with tentative approvals for LEVETIRACETAM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 500MG | TABLET;ORAL |
| Start Trial | Start Trial | 1GM | TABLET;ORAL |
| Start Trial | Start Trial | 750MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for levetiracetam
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for levetiracetam
| (-)-(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 |
| Keppra (TN) |
| Keppra XR |
| Keppra;Keppra XR |
| KS-00000ILW |
| KS-1176 |
| L-059 |
| L0234 |
| Levesam 500 |
| 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 LEVETIRACETAM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KEPPRA XR | TABLET, EXTENDED RELEASE;ORAL | levetiracetam | 022285 | 2011-01-07 |
| KEPPRA | TABLET;ORAL | levetiracetam | 021035 | 2007-01-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Inc | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078797-001 | Jan 15, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sparc | ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417-002 | Dec 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-004 | Jul 31, 2015 | 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 levetiracetam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | Start Trial | Start Trial |
| Aprecia Pharms | SPRITAM | levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958-001 | Jul 31, 2015 | Start Trial | Start Trial |
| Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for levetiracetam
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1909770 | Start Trial |
| Canada | 2581831 | Start Trial |
| South Africa | 200707250 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for levetiracetam
| 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.