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Last Updated: August 6, 2020

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LEVETIRACETAM Drug Profile

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When do Levetiracetam patents expire, and what generic alternatives are available?

Levetiracetam is a drug marketed by 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, 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, 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, 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, Zydus Pharms Usa Inc, Gland Pharma Ltd, and Hq Speciality Pharma. and is included in eighty-seven NDAs.

The generic ingredient in LEVETIRACETAM is levetiracetam. There are thirty-five drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

US ANDA Litigation and Generic Entry Outlook for Levetiracetam

A generic version of LEVETIRACETAM was approved as levetiracetam by MYLAN on November 4th, 2008.

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Drug patent expirations by year for LEVETIRACETAM
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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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
Torrent Pharms Ltd LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091338-001 May 29, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell Rx LEVETIRACETAM levetiracetam TABLET;ORAL 201293-002 Jun 14, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091261-001 Sep 12, 2011 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

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