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.

This drug has six patent family members in four countries.

The generic ingredient in MOTPOLY XR is lacosamide. There are twenty-two drug master file entries for this compound. Forty-seven 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:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in MOTPOLY XR?	MOTPOLY XR excipients list
DailyMed Link:	MOTPOLY XR at DailyMed

Pharmacology for MOTPOLY XR

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

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/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

International Patents for MOTPOLY XR

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

Country	Patent Number	Title	Estimated Expiration
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)
Canada	3148705	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PREPARATION PHARMACEUTIQUE (LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF)
European Patent Office	3981390	COMPOSITION PHARMACEUTIQUE DE LACOSAMIDE ET SA PRÉPARATION PHARMACEUTIQUE (LACOSAMIDE 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	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
0888289	C300376	Netherlands		PRODUCT NAME: LACOSAMIDE; REGISTRATION NO/DATE: EU/1/08/470/001-016 20080829

MOTPOLY XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MOTPOLY XR

Introduction to MOTPOLY XR

MOTPOLY XR, an extended-release formulation of lacosamide, is a significant addition to the treatment options for partial-onset seizures in adults and pediatric patients weighing at least 50 kg. Developed by Aucta Pharmaceuticals, Inc., this drug marks a major milestone as the company's first branded pharmaceutical product to enter the US market[1][4].

Market Need and Target Population

The market for antiepileptic drugs is substantial, driven by the prevalence of epilepsy and the need for effective and convenient treatment options. MOTPOLY XR addresses this need by offering a once-daily formulation, which can enhance patient compliance and quality of life. The target population includes adults and pediatric patients (weighing at least 50 kg) suffering from partial-onset seizures, a condition that affects a significant portion of the epilepsy patient population[1][4].

Competitive Landscape

MOTPOLY XR enters a market where immediate-release lacosamide, marketed under the brand name Vimpat®, is already established. However, MOTPOLY XR's extended-release formulation provides a unique selling point, offering patients a more convenient dosing regimen compared to the immediate-release versions. The absence of a generic version for MOTPOLY XR at the time of its launch gives it a competitive edge, although generic alternatives to Vimpat are available with narrower indications due to marketing exclusivity rights[4].

Pricing and Cost Considerations

The pricing of MOTPOLY XR is a critical factor in its market dynamics. The cost for a 60-capsule supply of MOTPOLY XR (100 mg or 150 mg) is approximately $1,325.75 for cash-paying customers, which is a significant expense for many patients. However, Aucta Pharmaceuticals offers a copay savings program, which can reduce the cost for commercially insured patients to as little as $10 for a 30-day supply[2].

Financial Trajectory

Launch and Commercial Strategy

Aucta Pharmaceuticals has implemented a comprehensive commercial strategy to support the launch of MOTPOLY XR. This includes field and inside sales teams, managed care and formulary access support, and a copay savings program. These initiatives are designed to ensure strong market penetration and patient access to the drug[1].

Revenue Potential

Given the high demand for effective antiepileptic medications and the convenience of a once-daily dosing regimen, MOTPOLY XR is poised to generate significant revenue. The drug's bioequivalence to Vimpat and its approval for a broad patient population (including pediatric patients) further enhance its revenue potential[1][4].

Cost-Benefit Analysis

For patients, the convenience of a once-daily extended-release formulation can lead to better adherence and potentially improved seizure control, which can reduce the overall cost of care in the long term. For healthcare systems, the reduced need for frequent dosing and potential decrease in hospitalizations due to seizure-related complications can also be cost-effective[4].

Safety and Efficacy Considerations

Safety Profile

MOTPOLY XR comes with several warnings and precautions, including the risk of suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and drug reaction with eosinophilia and systemic symptoms (DRESS)/multi-organ hypersensitivity. These safety concerns must be carefully managed by healthcare providers to ensure patient safety[1][4].

Efficacy

The efficacy of MOTPOLY XR is supported by its relative bioavailability compared to immediate-release lacosamide. Clinical trials have shown that MOTPOLY XR is effective in controlling partial-onset seizures in both adults and pediatric patients, with adverse reaction profiles similar to those seen with Vimpat[4].

Regulatory Environment

MOTPOLY XR received FDA approval on May 4, 2023, for the treatment of partial-onset seizures in adults and pediatric patients weighing at least 50 kg. This approval was based on the drug's bioequivalence to Vimpat and its demonstrated safety and efficacy in clinical trials[4].

Patient Access and Affordability

To improve patient access, Aucta Pharmaceuticals has introduced a copay savings program, which significantly reduces the out-of-pocket cost for commercially insured patients. This initiative helps make the drug more affordable for those who need it, enhancing its market acceptance and patient adherence[2].

Future Outlook

Market Growth

The epilepsy treatment market is expected to grow, driven by increasing prevalence and the need for innovative treatments. MOTPOLY XR, with its unique once-daily dosing regimen, is well-positioned to capture a significant share of this growing market.

Competitive Challenges

As the market evolves, MOTPOLY XR may face competition from new antiepileptic drugs or generic versions of existing drugs. However, its current market exclusivity and the convenience it offers are likely to maintain its competitive edge.

Key Takeaways

• Market Need: MOTPOLY XR addresses the need for convenient and effective antiepileptic treatment options.
• Competitive Edge: The once-daily extended-release formulation provides a unique selling point.
• Pricing and Cost: High initial cost but mitigated by copay savings programs.
• Financial Trajectory: Strong revenue potential due to high demand and comprehensive commercial strategy.
• Safety and Efficacy: Effective but with significant safety precautions.
• Regulatory Approval: FDA-approved with a clear regulatory pathway.
• Patient Access: Enhanced by copay savings programs.

FAQs

Q: What is MOTPOLY XR used for? A: MOTPOLY XR is used for the treatment of partial-onset seizures in adults and pediatric patients weighing at least 50 kg[1][4].

Q: How does MOTPOLY XR differ from Vimpat? A: MOTPOLY XR is an extended-release formulation of lacosamide, whereas Vimpat is an immediate-release formulation. This allows for once-daily dosing with MOTPOLY XR[1][4].

Q: What are the common adverse reactions associated with MOTPOLY XR? A: The most common adverse reactions include diplopia, headache, dizziness, nausea, and somnolence[1][4].

Q: Is MOTPOLY XR available through generic alternatives? A: Currently, MOTPOLY XR is available only as a brand name drug, with no generic version available[2].

Q: How much does MOTPOLY XR cost, and are there any savings programs available? A: The cost for a 60-capsule supply is around $1,325.75, but Aucta Pharmaceuticals offers a copay savings program that can reduce the cost to as little as $10 for a 30-day supply for commercially insured patients[2].

Sources

1. Aucta Pharmaceuticals, Inc. - "Aucta Pharmaceuticals Launches MOTPOLY XR (Lacosamide) Extended-Release Capsules C-V" - PR Newswire.
2. Drugs.com - "Motpoly XR Prices, Coupons, Copay Cards & Patient Assistance".
3. FDA - "Motpoly XR (Lacosamide) - Clinical Pharmacology Review".
4. Optum Rx - "Motpoly XR (lacosamide) – New drug approval".
5. FDA - "Motpoly™ XR - accessdata.fda.gov".