.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Dow
Novartis
Fish and Richardson
Queensland Health
Chinese Patent Office
Chubb
Medtronic
US Army
AstraZeneca
Cerilliant

Generated: November 24, 2017

DrugPatentWatch Database Preview

Levetiracetam - Generic Drug Details

« Back to Dashboard

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, Acic Pharms, Hospira Inc, Mylan Pharms Inc, Pharmtak 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-eight 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-seven patent family members in nineteen countries and two supplementary protection certificates in two 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.

Pharmacology for levetiracetam

Tentative approvals for LEVETIRACETAM

Applicant Application No. Strength Dosage Form
u► Subscribe250MGTABLET;ORAL
u► Subscribe500MGTABLET;ORAL
u► Subscribe1GMTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmtak Inc
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL207175-001Sep 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Orit Labs Llc
LEVETIRACETAM
levetiracetam
SOLUTION;ORAL203067-001May 9, 2013AARXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
LEVETIRACETAM
levetiracetam
TABLET;ORAL077324-002Jan 15, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Intellipharmaceutics
LEVETIRACETAM
levetiracetam
TABLET, EXTENDED RELEASE;ORAL204511-002Feb 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Luitpold
LEVETIRACETAM
levetiracetam
INJECTABLE;IV (INFUSION)202143-001Jan 31, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Aci Healthcare Ltd
LEVETIRACETAM
levetiracetam
TABLET;ORAL078042-002Jan 15, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
LEVETIRACETAM
levetiracetam
TABLET;ORAL090511-003Aug 18, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
LEVETIRACETAM
levetiracetam
TABLET;ORAL078918-002Apr 29, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Inc
LEVETIRACETAM
levetiracetam
TABLET;ORAL078797-001Jan 15, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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, 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;ORAL021035-003Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-002Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-003Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA XR
levetiracetam
TABLET, EXTENDED RELEASE;ORAL022285-001Sep 12, 2008► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
INJECTABLE;IV (INFUSION)021872-001Jul 31, 2006► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-002Nov 30, 1999► Subscribe► Subscribe
Ucb Inc
KEPPRA
levetiracetam
TABLET;ORAL021035-004Jan 6, 2006► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: levetiracetam

Country Document Number Estimated Expiration
Japan2016514680► Subscribe
Canada2595988► Subscribe
Eurasian Patent Organization200701575► Subscribe
Mexico2007009088► Subscribe
Japan2017071626► Subscribe
Australia2014228990► Subscribe
Germany69840495► Subscribe
Israel184822► Subscribe
European Patent Office1301177► Subscribe
Japan2008528571► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
QuintilesIMS
Teva
Chubb
AstraZeneca
Accenture
McKinsey
US Army
UBS
Federal Trade Commission

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot