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Last Updated: August 3, 2021

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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 freedom to operate?

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, Nexus Pharms, Aci Healthcare Ltd, Actavis Mid Atlantic, Alembic Labs, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Lannett Co Inc, Lupin Ltd, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Florida, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharma Life, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Viwit Pharm, Vkt Pharma, Watson Labs Inc, Wockhardt, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in ninety-six 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-three patent family members in thirty countries.

There are thirty-five drug master file entries for levetiracetam. Eighty-one suppliers are listed for this compound. There are two tentative approvals 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CureRareDisease LLCPhase 1/Phase 2
Janssen Research & Development, LLCPhase 2
University of CambridgePhase 3

See all LEVETIRACETAM clinical trials

Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free500MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free1GMTABLET;ORAL
⤷  Try it Free⤷  Try it Free750MGTABLET;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
Aci Healthcare Ltd LEVETIRACETAM levetiracetam TABLET;ORAL 078042-004 Jan 15, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nostrum Labs Inc LEVETIRACETAM levetiracetam TABLET;ORAL 090511-002 Aug 18, 2011 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Mid Atlantic LEVETIRACETAM levetiracetam SOLUTION;ORAL 078976-001 Jan 15, 2009 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nexus Pharms LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;INTRAVENOUS 213532-002 Jul 6, 2020 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pharma Life LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 204754-001 Aug 26, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 078101-002 Jan 15, 2009 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd LEVETIRACETAM levetiracetam TABLET;ORAL 078904-001 Jan 15, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 207958-004 Jul 31, 2015 ⤷  Try it Free ⤷  Try it Free
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ⤷  Try it Free ⤷  Try it Free
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 Jul 31, 2015 ⤷  Try it Free ⤷  Try it Free
Ucb Inc KEPPRA levetiracetam INJECTABLE;INTRAVENOUS 021872-001 Jul 31, 2006 ⤷  Try it Free ⤷  Try it Free
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015 ⤷  Try it Free ⤷  Try it Free
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-001 Jul 31, 2015 ⤷  Try it Free ⤷  Try it Free
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036 2000C/032 Belgium ⤷  Try it Free 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:

Harvard Business School
Moodys
Boehringer Ingelheim
Mallinckrodt
Colorcon
Medtronic

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