LACOSAMIDE Drug Patent Profile
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When do Lacosamide patents expire, and when can generic versions of Lacosamide launch?
Lacosamide is a drug marketed by Apotex, Aspiro, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Indoco, MSN, Zydus Pharms, Alkem Labs Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm. and is included in twenty-nine NDAs.
The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lacosamide
A generic version of LACOSAMIDE was approved as lacosamide by ALEMBIC on March 17th, 2022.
Summary for LACOSAMIDE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 29 |
| Finished Product Suppliers / Packagers: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 97 |
| Patent Applications: | 1,797 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LACOSAMIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LACOSAMIDE |
| What excipients (inactive ingredients) are in LACOSAMIDE? | LACOSAMIDE excipients list |
| DailyMed Link: | LACOSAMIDE at DailyMed |
Recent Clinical Trials for LACOSAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Overseas Pharmaceuticals, Ltd. | Phase 1 |
| Beijing Capton Pharmaceutical Technology Development Co., LTD | Phase 1 |
| Wayne State University | Phase 4 |
Pharmacology for LACOSAMIDE
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LACOSAMIDE
Paragraph IV (Patent) Challenges for LACOSAMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIMPAT | Injection | lacosamide | 10 mg/mL, 20 mL | 022254 | 1 | 2016-06-30 |
| VIMPAT | Tablets | lacosamide | 50 mg, 100 mg, 150 mg, and 200 mg | 022253 | 14 | 2012-10-29 |
| VIMPAT | Oral Solution | lacosamide | 10 mg/mL | 022255 | 3 | 2012-10-29 |
US Patents and Regulatory Information for LACOSAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | LACOSAMIDE | lacosamide | TABLET;ORAL | 204994-002 | Jan 5, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal Pharms | LACOSAMIDE | lacosamide | TABLET;ORAL | 204857-001 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | LACOSAMIDE | lacosamide | TABLET;ORAL | 204787-002 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sciegen Pharms Inc | LACOSAMIDE | lacosamide | TABLET;ORAL | 205237-001 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Glenmark Pharms Ltd | LACOSAMIDE | lacosamide | TABLET;ORAL | 205006-002 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | LACOSAMIDE | lacosamide | TABLET;ORAL | 204787-003 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Indoco | LACOSAMIDE | lacosamide | TABLET;ORAL | 208308-004 | Mar 17, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 LACOSAMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| UCB Pharma SA | Vimpat | lacosamide | EMEA/H/C/000863 Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. |
Authorised | no | no | no | 2008-08-29 | |
| UCB Pharma S.A. | Lacosamide UCB | lacosamide | EMEA/H/C/005243 Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy., |
Authorised | no | no | no | 2019-08-26 | |
| Accord Healthcare S.L.U. | Lacosamide Accord | lacosamide | EMEA/H/C/004443 Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.Lacosamide Accord is indicated as adjunctive therapy• in 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 primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy. |
Authorised | yes | no | no | 2017-09-18 | |
| Extrovis EU Ltd. | Lacosamide Adroiq | lacosamide | EMEA/H/C/006047 Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.Lacosamide Adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy. |
Authorised | yes | no | no | 2023-05-31 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
