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

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2029

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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

74 trials from ClinicalTrials.gov, 61 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 NCT02582866	Phase 3	Completed	UCB Biopharma S.P.R.L.	106	2016-01 → 2020-01
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures NCT00938431	Phase 2	Completed	UCB Pharma	47	2009-11 → 2014-08
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures NCT00955357	Phase 4	Completed	UCB Pharma	461	2009-08 → 2013-08
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy NCT01118949	Phase 2	Completed	UCB BIOSCIENCES, Inc.	49	2010-05 → 2011-08
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures NCT01832038	Phase 3	Completed	UCB Pharma SA	473	2013-03-26 → 2019-07-31
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures NCT00515619	Phase 3	Completed	UCB Pharma	376	2004-12 → 2010-08
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures NCT00552305	Phase 2	Completed	UCB Pharma	370	2001-08 → 2010-02
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older NCT01243177	Phase 3	Completed	UCB BIOSCIENCES GmbH	888	2011-04 → 2015-08
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy NCT01190098	Phase 4	Completed	The Cleveland Clinic	59	2010-08 → 2014-11
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy NCT00350103	Phase 3	Completed	UCB Pharma	551	2006-06-30 → 2007-06-29

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$21.51

per ea

Lowest NADAC/Unit

$21.43

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
73289006502MOTPOLY XR 200 MG CAPSULE	$21.51	EA	Brand	—	2026-07-01
73289006402MOTPOLY XR 150 MG CAPSULE	$21.50	EA	Brand	—	2026-07-01
73289006302MOTPOLY XR 100 MG CAPSULE	$21.43	EA	Brand	—	2026-07-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$628.14

Highest Price

$628.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73289-0063-02MOTPOLY XR 100MG CAP,SA	$628.14	FSS	Aucta Pharmaceuticals, Inc.	11/14/2029
73289-0064-02MOTPOLY XR 150MG CAP,SA	$628.14	FSS	Aucta Pharmaceuticals, Inc.	11/14/2029
73289-0065-02MOTPOLY XR 200MG CAP,SA	$628.14	FSS	Aucta Pharmaceuticals, Inc.	11/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Motpoly XR (2024)

Total Spending

$394K

Total Claims

349

Beneficiaries

106

Avg Cost/Unit

$20.11

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain33 active DMFs3 inactive

29 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

LUNA CHEMICALS CO LTDLACOSAMIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 432542025

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) · 6 use codes

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