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Generated: September 20, 2017

DrugPatentWatch Database Preview

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 Hi-tech Pharmacal, Teva Pharms, Secan Pharms, Dr Reddys Labs Ltd, Ucb Inc, Prinston Inc, Lotus Pharm Co Ltd, 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 Generics, Torrent Pharms Ltd, Aci Healthcare Ltd, Luitpold, Hq Speciality Pharma, Accord Hlthcare, Sun Pharm Inds Ltd, Eci Pharms Llc, 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, Allied Pharma Inc, 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-six patent family members in nineteen countries.

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

Summary for Generic Name: levetiracetam

Tradenames:6
Patents:6
Applicants:60
NDAs:87
Drug Master File Entries: see list35
Suppliers / Packagers: see list96
Bulk Api Vendors: see list78
Clinical Trials: see list173
Patent Applications: see list3,164
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. Strength Dosage Form
► Subscribe► Subscribe250MGTABLET;ORAL
► Subscribe► Subscribe500MGTABLET;ORAL
► Subscribe► Subscribe1GMTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Methapharm
LEVETIRACETAM
levetiracetam
TABLET;ORAL090767-002Jul 28, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL091285-001Sep 12, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Hq Speciality Pharma
LEVETIRACETAM IN SODIUM CHLORIDE
levetiracetam
INJECTABLE;IV (INFUSION)202543-001Nov 9, 2011APRXYesYes► Subscribe► Subscribe► Subscribe
Aprecia Pharms Co
SPRITAM
levetiracetam
TABLET, FOR SUSPENSION;ORAL207958-003Jul 31, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Aprecia Pharms Co
SPRITAM
levetiracetam
TABLET, FOR SUSPENSION;ORAL207958-003Jul 31, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Vintage Pharms
LEVETIRACETAM
levetiracetam
TABLET;ORAL091491-004Dec 14, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Pharm Assoc
LEVETIRACETAM
levetiracetam
SOLUTION;ORAL201157-001Jun 4, 2015AARXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
LEVETIRACETAM
levetiracetam
INJECTABLE;IV (INFUSION)090754-001Jun 16, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Dexcel Pharma
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL202167-001Sep 4, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lotus Pharm Co Ltd
ROWEEPRA
levetiracetam
TABLET;ORAL090906-001Nov 5, 2010ABRXNoNo► Subscribe► 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 XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
SOLUTION;ORAL021505-001Jul 15, 2003► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-001Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-001Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-004Jan 6, 2006► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
INJECTABLE;IV (INFUSION)021872-001Jul 31, 2006► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-003Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-003Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
SOLUTION;ORAL021505-001Jul 15, 2003► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-002Nov 30, 1999► Subscribe► 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
Australia6331498► Subscribe
Australia7368701► Subscribe
Japan5091910► Subscribe
Australia2014228990► Subscribe
China101111245► Subscribe
European Patent Office2968994► Subscribe
Germany69840495► Subscribe
Germany05815688► Subscribe
Hong Kong1214787► Subscribe
BrazilPI0518506► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Julphar
Mallinckrodt
QuintilesIMS
UBS
Chinese Patent Office
Farmers Insurance
Colorcon
Citi
Novartis

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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