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Last Updated: July 12, 2020

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Levetiracetam - Generic Drug Details

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What are the generic sources for levetiracetam and what is the scope of patent protection?

Levetiracetam is the generic ingredient in six 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, Xgen 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, Apotex, 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, Viwit Pharm, 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-two patent family members in thirty countries.

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

Drug Prices for levetiracetam

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Drug Sales Revenue Trends for levetiracetam

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Recent Clinical Trials for levetiracetam

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SponsorPhase
NYU Langone HealthPhase 2
Walter Reed National Military Medical CenterPhase 2
Lady Hardinge Medical CollegePhase 2/Phase 3

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Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial750MGTABLET;ORAL
  Start Trial  Start Trial250MGTABLET;ORAL
  Start Trial  Start Trial500MGTABLET;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
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
Breckenridge Pharm LEVETIRACETAM levetiracetam TABLET;ORAL 090511-001 Aug 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 078101-001 Jan 15, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 209934-001 May 4, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc LEVETIRACETAM levetiracetam SOLUTION;ORAL 090263-001 Apr 3, 2009 AA RX No No   Start Trial   Start Trial   Start Trial
Taro LEVETIRACETAM levetiracetam TABLET;ORAL 078960-002 Feb 1, 2010 AB RX No No   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
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015   Start Trial   Start Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-004 Jul 31, 2015   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam INJECTABLE;INTRAVENOUS 021872-001 Jul 31, 2006   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999   Start Trial   Start Trial
Ucb Inc KEPPRA XR levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285-001 Sep 12, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Baxter
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Dow
Harvard Business School

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 verification 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.