LEVETIRACETAM IN SODIUM CHLORIDE Drug Patent Profile
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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-seven 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 4th, 2008.
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Summary for LEVETIRACETAM IN SODIUM CHLORIDE
US Patents: | 0 |
Applicants: | 8 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 132 |
Clinical Trials: | 225 |
Patent Applications: | 3,215 |
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 |
---|---|
University of North Carolina, Chapel Hill | Phase 4 |
AgeneBio | Phase 2 |
McMaster University | Phase 3 |
Pharmacology for LEVETIRACETAM IN SODIUM CHLORIDE
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 211356-001 | Feb 12, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Nexus | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 213532-003 | Jul 6, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 207160-002 | Jan 4, 2017 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |