Lacosamide - Generic Drug Details

What are the generic drug sources for lacosamide and what is the scope of patent protection?

Lacosamide is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Indoco, Zydus Pharms, Ucb Inc, Alkem Labs Ltd, Hetero Labs Ltd Iii, Alembic Pharms Ltd, Amneal Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd V, Msn Labs Pvt Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in seventeen NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lacosamide has twenty-two patent family members in eleven countries.

There are twenty-two drug master file entries for lacosamide. Twenty-two suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for lacosamide

International Patents:	22
US Patents:	1
Tradenames:	2
Applicants:	13
NDAs:	17
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	90
Patent Applications:	3,668
Formulation / Manufacturing:	see details
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
Sherief Abd-Elsalam	Phase 3
UCB Biopharma SRL	Phase 2/Phase 3
Tongji Hospital	Phase 4

See all lacosamide clinical trials

Generic filers with tentative approvals for LACOSAMIDE

Applicant	Application No.	Strength	Dosage Form
		150MG	TABLET;ORAL
		100MG	TABLET;ORAL
		50MG	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 lacosamide

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity Decreased Central Nervous System Disorganized Electrical Activity

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
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008	AP	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	SOLUTION;ORAL	022255-001	Apr 20, 2010	AA	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	AB	RX	Yes	Yes
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008	AB	RX	Yes	Yes			Y	Y

Expired US Patents for lacosamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-001	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-003	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	TABLET;ORAL	022253-004	Oct 28, 2008
Ucb Inc	VIMPAT	lacosamide	SOLUTION;INTRAVENOUS	022254-001	Oct 28, 2008

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

International Patents for lacosamide

Country	Patent Number	Title	Estimated Expiration
Canada	2248317	DERIVES AMINOACIDES ENANTIOMERIQUES AYANT UN EFFET ANTI-CONVULSIF (ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES)
Spain	2218024
World Intellectual Property Organization (WIPO)	9733861
Austria	202079

Supplementary Protection Certificates for lacosamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0888289	C00888289/01	Switzerland		PRODUCT NAME: LACOSAMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 59004 28.08.2009
0888289	CA 2009 00001	Denmark
0888289	09C0006	France		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/470/001 DU 20080829; REGISTRATION NO/DATE AT EEC: EU/1/08/470/001 DU 20080829
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829