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Levetiracetam - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levetiracetam?

Levetiracetam is the generic ingredient in five branded drugs marketed by Hi-tech Pharmacal, Teva Pharms, Secan Pharms, Dr Reddys Labs Ltd, Ucb Inc, Lotus Pharm Co Ltd, Prinston Inc, Tolmar, Mylan Labs Ltd, Actavis Labs Fl Inc, Intellipharmaceutics, Breckenridge Pharm, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hetero Labs Ltd Iii, Zydus Pharms Usa Inc, Mylan, Vintage Pharms, Rouses Point Pharms, Sandoz, Lupin, Orchid Hlthcare, Sagent Pharms, Wockhardt, Invagen Pharms, Jubilant Life, Torrent Pharms Ltd, Roxane, Luitpold, Hq Speciality Pharma, Accord Hlthcare, Sun Pharm Inds Ltd, Nostrum Labs Inc, Pharm Assoc, Actavis Elizabeth, Apotex Inc, Aprecia Pharms Co, Torrent Pharms, Sun Pharma Global, Anchen Pharms, Taro, Tris Pharma Inc, Silarx, Pharmadax Inc, Orit Labs Llc, Dexcel Pharma, Methapharm, Hospira Inc, Mylan Pharms Inc, Actavis Mid Atlantic, Hikma Farmaceutica, X Gen Pharms, Sun Pharm Inds, Virtus Pharms, Amneal Pharms, Lupin Ltd, Ajanta Pharma, Aurobindo Pharma, and Watson Labs Inc, and is included in eighty-seven 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 forty-four patent family members in nineteen countries.

There are thirty-five drug master file entries for levetiracetam. Ninety-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: levetiracetam

Tradenames:5
Patents:6
Applicants:59
NDAs:87
Drug Master File Entries: see list35
Suppliers / Packagers: see list94
Bulk Api Vendors: see list78
Clinical Trials: see list37
Patent Applications: see list3,044
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:levetiracetam at DailyMed

Pharmacology for Ingredient: levetiracetam

Tentative approvals for LEVETIRACETAM

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL250MG
► Subscribe► SubscribeTABLET;ORAL750MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmadax Inc
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL201464-001May 25, 2012RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL200475-003Dec 7, 2015RXNoNo► Subscribe► Subscribe
Apotex Inc
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL091261-002Sep 12, 2011RXNoNo► Subscribe► Subscribe
Dexcel Pharma
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL202167-001Sep 4, 2015RXNoNo► Subscribe► Subscribe
Torrent Pharms
LEVETIRACETAM
levetiracetam
TABLET;ORAL078858-001Jan 15, 2009RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: levetiracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
KEPPRA
levetiracetam
SOLUTION;ORAL021505-001Jul 15, 20034,837,223► Subscribe
Ucb Inc
KEPPRA
levetiracetam
INJECTABLE;IV (INFUSION)021872-001Jul 31, 20064,943,639*PED► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-002Nov 30, 19994,837,223► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-003Nov 30, 19994,943,639*PED► Subscribe
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 20084,943,639*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,114,072Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same► Subscribe
7,863,316Extended release formulation of Levetiracetam► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: levetiracetam

Country Document Number Estimated Expiration
Canada2595988► Subscribe
Japan2001512488► Subscribe
Ukraine89216► Subscribe
Mexico2015012134► Subscribe
Spain2318869► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LEVETIRACETAM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00028Netherlands► SubscribePRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
00C/032Belgium► SubscribePRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
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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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