Viewing data from:

MOTPOLY XR

NDA

LACOSAMIDE | N216185 | AUCTA PHARMACEUTICALS INC

3 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

11337943

Jun. 5, 2040

11883374

Jun. 5, 2040

12042474

Jun. 5, 2040

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
SHANGHAI AUCTA PHARMACEUTICALS CO. LTD. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 1:2026cv02954 3 patentsANDA 220959lacosamide	D.N.J.	2026-03-23	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain32 active DMFs3 inactive

28 active API suppliers hold Drug Master Files for this ingredient.

HETERO DRUGS LTDLACOSAMIDE

DMF 261362012

SUN PHARMACEUTICAL INDUSTRIES LTDLACOSAMIDE USP

DMF 261742012

MSN PHARMACHEM PRIVATE LTDLACOSAMIDE USP [ROUTE CODE - "LD"]

DMF 262702012

APITORIA PHARMA PRIVATE LTDLACOSAMIDE (NON-STERILE DRUG SUBSTANCE)

DMF 263132012

ALIVUS LIFE SCIENCES LTDLACOSAMIDE USP

DMF 263232012

ALEMBIC PHARMACEUTICALS LTDLACOSAMIDE USP

DMF 263492012

TAPI NL BVLACOSAMIDE

DMF 263812012

CURIA MISSOURI INCLACOSAMIDE

DMF 263822012

ZYDUS LIFESCIENCES LTDLACOSAMIDE USP

DMF 264722012

SIGNA SA DE CVLACOSAMIDE

DMF 264842012

INTAS PHARMACEUTICALS LTDLACOSAMIDE

DMF 265202012

SYMPHONY PHARMA LIFESCIENCES PRIVATE LTDLACOSAMIDE

DMF 265942012

MACLEODS PHARMACEUTICALS LTDLACOSAMIDE

DMF 287972014

JUBILANT BIOSYS LTDLACOSAMIDE

DMF 291702015

INDOCO REMEDIES LTDLACOSAMIDE USP

DMF 294762015

CAMBREX PROFARMACO MILANO SRLLACOSAMIDE

DMF 297632015

HIKAL LTDLACOSAMIDE USP

DMF 303452016

UNICHEM LABORATORIES LTDLACOSAMIDE

DMF 324302018

CHIERON ACTIVE INGREDIENTS PRIVATE LTDLACOSAMIDE

DMF 335522019

BEIJING HOPE PHARMACEUTICAL CO LTDLACOSAMIDE

DMF 336782019

WISDOM PHARMACEUTICAL CO LTDLACOSAMIDE

DMF 341072019

MSN PHARMACHEM PRIVATE LTDLACOSAMIDE USP (ROUTE CODE-LS)

DMF 347372020

GLAND PHARMA LTDLACOSAMIDE

DMF 347842020

DIVIS LABORATORIES LTDLACOSAMIDE

DMF 357242021

INDOCO REMEDIES LTDLACOSAMIDE USP (PROCESS II)

DMF 367882022

EMNAR PHARMA PRIVATE LTDLACOSAMIDE USP

DMF 374462022

METROCHEM API PRIVATE LTDLACOSAMIDE USP

DMF 387892023

VIYASH LIFE SCIENCES PRIVATE LTDLACOSAMIDE USP

DMF 389782024

APITORIA PHARMA PRIVATE LTDLACOSAMIDE USP (PROCESS-II)

DMF 396502024

BEIJING HOPE PHARMACEUTICAL CO LTDLACOSAMIDE

DMF 400112024

CHROMO LABORATORIES INDIA PRIVATE LTDLACOSAMIDE USP

DMF 407342025

LEE PHARMA LTDLacosamide

DMF 419552025

DR REDDYS LABORATORIES LTDInactiveLACOSAMIDE

DMF 245992011

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLACOSAMIDE

DMF 262502012

LUPIN MANUFACTURING SOLUTIONS LTDInactiveLACOSAMIDE

DMF 278352013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 10, 2024	SUPPL -1	View Letter (PDF)
May 5, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLD

3 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 4, 2023

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11337943	Jun 5, 2040	—	—	Yes	—
11883374	Jun 5, 2040	—	—	Yes	—
12042474	Jun 5, 2040	—	—	Yes	—

#002 — 150MG

RLD

3 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 4, 2023

#003 — 200MG

RLD

3 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 4, 2023