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

Serving leading biopharmaceutical companies globally:

Fuji
Cerilliant
Queensland Health
Baxter
Argus Health
Mallinckrodt
Colorcon
US Army
Merck
Healthtrust

Generated: February 20, 2018

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 Ucb Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, 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, Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Breckenridge Pharm, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Silarx, Taro, Tolmar, Tris Pharma Inc, Vintage Pharms, 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, Aci Healthcare Ltd, Acic Pharms, Ajanta Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Secan Pharms, Torrent Pharms, Watson Labs Inc, Wockhardt, and Zydus Pharms Usa Inc, and is included in eighty-nine 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.

There are thirty-five drug master file entries for levetiracetam. Ninety-five 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
➤ Try a Free Trial➤ Try a Free Trial250MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial500MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial1GMTABLET;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
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Aurobindo Pharma Ltd LEVETIRACETAM levetiracetam SOLUTION;ORAL 079063-001 Jan 15, 2009 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vintage Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 077319-003 Mar 20, 2009 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pharmadax Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 201464-001 May 25, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Anchen Pharms LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091360-002 Oct 4, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Jubilant Generics LEVETIRACETAM levetiracetam INJECTABLE;IV (INFUSION) 206838-001 Jun 2, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ajanta Pharma LEVETIRACETAM levetiracetam TABLET;ORAL 201293-003 Jun 14, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 202958-001 Feb 25, 2015 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Eci Pharms Llc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 204754-002 Aug 26, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd LEVETIRACETAM levetiracetam TABLET;ORAL 076920-003 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

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

Expired US Patents for levetiracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc KEPPRA levetiracetam INJECTABLE;IV (INFUSION) 021872-001 Jul 31, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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

Non-Orange Book US Patents for 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
7,863,316 Extended release formulation of Levetiracetam ➤ Try a Free Trial
9,114,072 Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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

International Patents for levetiracetam

Supplementary Protection Certificates for levetiracetam

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00028 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Fuji
Cipla
Argus Health
Harvard Business School
UBS
Moodys
Teva

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.

botpot