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Last Updated: March 5, 2021

DrugPatentWatch Database Preview

Levetiracetam - Generic Drug Details

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What are the generic drug 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, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Sparc, 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, Breckenridge Pharm, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, 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. Seventy-nine 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
University of CambridgePhase 3
Cambridge University Hospitals NHS Foundation TrustPhase 3
Royal Brisbane and Women's HospitalPhase 2

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Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGTABLET;ORAL
  Start Trial  Start Trial1GMTABLET;ORAL
  Start Trial  Start Trial750MGTABLET;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
Accord Hlthcare LEVETIRACETAM levetiracetam TABLET;ORAL 090843-001 Feb 14, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Pharma Life LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 204754-001 Aug 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Zhejiang Jingxin LEVETIRACETAM levetiracetam TABLET;ORAL 091491-002 Dec 14, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 AB RX Yes No   Start Trial   Start Trial Y   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
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006   Start Trial   Start Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 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 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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