LEVETIRACETAM - Generic Drug Details

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, Beowulf Asset, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Gland Pharma Ltd, Hq Speciality Pharma, Nexus Pharms, ACI, Actavis Mid Atlantic, Aiping Pharm Inc, Alembic Labs, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Belcher, Breckenridge, Chartwell Molecular, Hetero Labs Ltd Iii, Lupin Ltd, Pharm Assoc, Taro, Tolmar, Wockhardt Bio Ag, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Anda Repository, Apotex, Dexcel, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Aprecia Pharms, Accord Hlthcare, Alkem Labs Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Secan Pharms, Stallion Labs, Torrent Pharms, Viwit Pharm, Vkt Pharma, Watson Labs Inc, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in one hundred and two NDAs. There are ten 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. Eighty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LEVETIRACETAM

International Patents:	92
US Patents:	10
Tradenames:	6
Applicants:	74
NDAs:	102
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	84
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	219
Patent Applications:	4,891
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LEVETIRACETAM
Drug Sales Revenues:	Drug sales revenues for LEVETIRACETAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVETIRACETAM
What excipients (inactive ingredients) are in LEVETIRACETAM?	LEVETIRACETAM excipients list
DailyMed Link:	LEVETIRACETAM at DailyMed

See drug prices for LEVETIRACETAM

See drug sales revenues for LEVETIRACETAM

Recent Clinical Trials for LEVETIRACETAM

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4
University of Auckland, New Zealand	Phase 2

See all LEVETIRACETAM clinical trials

Generic filers with tentative approvals for LEVETIRACETAM

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET;ORAL
		1GM	TABLET;ORAL
		750MG	TABLET;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

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for LEVETIRACETAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KEPPRA XR	Extended-release Tablets	levetiracetam	1000 mg	022285	2	2011-01-07
KEPPRA	Tablets	levetiracetam	1000 mg	021035	1	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
Oxford Pharms	LEVETIRACETAM	levetiracetam	TABLET;ORAL	077319-002	Mar 20, 2009	AB	RX	No	No
Sciegen Pharms Inc	LEVETIRACETAM	levetiracetam	TABLET;ORAL	215069-003	May 27, 2022	AB	RX	No	No
Gland Pharma Ltd	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	206880-001	Oct 25, 2017	AP	RX	No	No
Watson Labs Inc	LEVETIRACETAM	levetiracetam	TABLET;ORAL	078797-004	Jan 15, 2009		DISCN	No	No
Hetero Labs Ltd Iii	LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	203052-001	Feb 28, 2013	AA	RX	No	No

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	207958-003	Jul 31, 2015
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015

EU/EMA Drug Approvals for LEVETIRACETAM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277 Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783 Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290 Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024 Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355 Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03

International Patents for LEVETIRACETAM

Country	Patent Number	Title	Estimated Expiration
Japan	6170234
South Korea	20070095456	EXTENDED RELEASE FORMULATION OF LEVETIRACETAM
Mexico	2015012134	FORMA DE DOSIFICACION DE DISPERSION RAPIDA QUE CONTIENE LEVETIRACETAM. (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM.)
Canada	2906029	FORME PHARMACEUTIQUE A DISPERSION RAPIDE CONTENANT DU LEVETIRACETAM (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
Eurasian Patent Organization	014961	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ЛЕВЕТИРАЦЕТАМ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION)

Supplementary Protection Certificates for LEVETIRACETAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329