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Generated: May 30, 2017

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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 levetiracetam freedom to operate?

is the generic ingredient in six branded drugs marketed by Hi-tech Pharmacal, Teva Pharms, Secan Pharms, Dr Reddys Labs Ltd, Ucb Inc, Prinston Inc, Lotus Pharm Co Ltd, Tolmar, Mylan Labs Ltd, Actavis Labs Fl Inc, Intellipharmaceutics, Breckenridge Pharm, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hetero Labs Ltd Iii, Zydus Pharms Usa Inc, Mylan, Vintage Pharms, Rouses Point Pharms, Sandoz, Lupin, Orchid Hlthcare, Sagent Pharms, Wockhardt, Invagen Pharms, Jubilant Life, Torrent Pharms Ltd, Allied Pharma Inc, Luitpold, Hq Speciality Pharma, Accord Hlthcare, Sun Pharm Inds Ltd, Eci Pharms Llc, Pharm Assoc, Actavis Elizabeth, Apotex Inc, Aprecia Pharms Co, Torrent Pharms, Sun Pharma Global, Anchen Pharms, Taro, Tris Pharma Inc, Silarx, Pharmadax Inc, Orit Labs Llc, Dexcel Pharma, Methapharm, Hospira Inc, Mylan Pharms Inc, Actavis Mid Atlantic, Hikma Farmaceutica, X Gen Pharms, Sun Pharm Inds, Virtus Pharms, Amneal Pharms, Lupin Ltd, Ajanta Pharma, Aurobindo Pharma, and Watson Labs Inc, and is included in eighty-seven 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-four patent family members in nineteen countries.

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

Summary for Generic Name: levetiracetam

Drug Master File Entries: see list35
Suppliers / Packagers: see list97
Bulk Api Vendors: see list78
Clinical Trials: see list37
Patent Applications: see list3,044
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:levetiracetam at DailyMed

Pharmacology for Ingredient: levetiracetam

Tentative approvals for LEVETIRACETAM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe250MGTABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Virtus Pharms
TABLET, EXTENDED RELEASE;ORAL091291-001Sep 12, 2011ABRXNoNo► Subscribe► Subscribe
Prinston Inc
TABLET, EXTENDED RELEASE;ORAL203468-002May 21, 2015ABRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
INJECTABLE;IV (INFUSION)203308-001Sep 16, 2016APRXNoNo► Subscribe► Subscribe
Prinston Inc
TABLET, EXTENDED RELEASE;ORAL203468-001May 21, 2015ABRXNoNo► Subscribe► Subscribe
Ajanta Pharma
TABLET;ORAL201293-003Jun 14, 2011ABRXNoNo► Subscribe► Subscribe
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