MOTPOLY XR Drug Patent Profile

Which patents cover Motpoly Xr, and what generic alternatives are available?

Motpoly Xr is a drug marketed by Aucta and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has fifteen patent family members in twelve countries.

The generic ingredient in MOTPOLY XR is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the lacosamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Motpoly Xr

A generic version of MOTPOLY XR was approved as lacosamide by ALEMBIC on March 17^th, 2022.

Summary for MOTPOLY XR

International Patents:	15
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for MOTPOLY XR
What excipients (inactive ingredients) are in MOTPOLY XR?	MOTPOLY XR excipients list
DailyMed Link:	MOTPOLY XR at DailyMed

See drug prices for MOTPOLY XR

Pharmacology for MOTPOLY XR

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for MOTPOLY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOTPOLY XR	Extended-release Capsules	lacosamide	100 mg and 150 mg	216185	1	2026-02-10
MOTPOLY XR	Extended-release Capsules	lacosamide	200 mg	216185	1	2025-12-29

US Patents and Regulatory Information for MOTPOLY XR

MOTPOLY XR is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No			Y
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-002	May 4, 2023		RX	Yes	No			Y
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No			Y
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-002	May 4, 2023		RX	Yes	No			Y

EU/EMA Drug Approvals for MOTPOLY XR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Vimpat	lacosamide	EMEA/H/C/000863Vimpat 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/005243Lacosamide 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/004443Lacosamide 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/006047Lacosamide 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

International Patents for MOTPOLY XR

See the table below for patents covering MOTPOLY XR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF)
China	112043681	一种拉考沙胺药物组合物及其药物制剂 (Lacosamide pharmaceutical composition and pharmaceutical preparation thereof)
China	114173763	一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof)
China	114404393	一种拉考沙胺药物组合物及其药物制剂 (Lacosaxamide pharmaceutical composition and pharmaceutical preparation thereof)

Supplementary Protection Certificates for MOTPOLY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0888289	SPC/GB09/007	United Kingdom		PRODUCT NAME: LACOSAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE FORMS; REGISTERED: UK EU/1/08/470/001 20080829; UK EU/1/08/470/002 20080829; UK EU/1/08/470/003 20080829; UK EU/1/08/470/004 20080829; UK EU/1/08/470/005 20080829; UK EU/1/08/470/006 20080829; UK EU/1/08/470/014 20080829; UK EU/1/08/470/015 20080829; UK EU/1/08/470/016 20080829; UK EU/1/08/470/007 20080829; UK EU/1/08/470/008 20080829; UK EU/1/08/470/009 20080829; UK EU/1/08/470/010 20080829; UK EU/1/08/470/012 20080829; UK EU/1/08/470/013 20080829