LEVETIRACETAM IN SODIUM CHLORIDE Drug Patent Profile

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

Levetiracetam In Sodium Chloride is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, and Nexus. and is included in eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levetiracetam In Sodium Chloride

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

Summary for LEVETIRACETAM IN SODIUM CHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	223
Patent Applications:	3,249
Formulation / Manufacturing:	see details
DailyMed Link:	LEVETIRACETAM IN SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for LEVETIRACETAM IN SODIUM CHLORIDE

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

Sponsor	Phase
AgeneBio	Phase 2
Hamilton Health Sciences Corporation	Phase 3
McMaster University	Phase 3

See all LEVETIRACETAM IN SODIUM CHLORIDE clinical trials

Pharmacology for LEVETIRACETAM IN SODIUM CHLORIDE

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for LEVETIRACETAM IN SODIUM CHLORIDE

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for LEVETIRACETAM IN SODIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun Medical Inc	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	209705-001	Feb 27, 2024	AP	RX	No	No
Hikma	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	211356-001	Feb 12, 2024	AP	RX	No	No
Nexus	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	213532-003	Jul 6, 2020	AP	RX	No	No
Eugia Pharma	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	207160-002	Jan 4, 2017	AP	RX	No	No
Baxter Hlthcare Corp	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	217059-003	Oct 2, 2023	AP	RX	No	No
Fresenius Kabi Usa	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	208619-001	Jan 31, 2023	AP	RX	No	No

EU/EMA Drug Approvals for LEVETIRACETAM IN SODIUM CHLORIDE

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
Actavis Group PTC ehf	Levetiracetam Actavis Group	levetiracetam	EMEA/H/C/002305 Levetiracetam Actavis Group 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 Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 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	2011-12-04