OSMOLEX ER Drug Patent Profile

When do Osmolex Er patents expire, and what generic alternatives are available?

Osmolex Er is a drug marketed by Supernus Pharms and is included in one NDA. There are nineteen patents protecting this drug.

This drug has fifteen patent family members in nine countries.

The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Osmolex Er

A generic version of OSMOLEX ER was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5^th, 1986.

Summary for OSMOLEX ER

International Patents:	15
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for OSMOLEX ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSMOLEX ER
What excipients (inactive ingredients) are in OSMOLEX ER?	OSMOLEX ER excipients list
DailyMed Link:	OSMOLEX ER at DailyMed

See drug prices for OSMOLEX ER

Pharmacology for OSMOLEX ER

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

US Patents and Regulatory Information for OSMOLEX ER

OSMOLEX ER is protected by twenty-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
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	8,987,333		Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	8,895,617
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	10,512,617
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	8,895,618		Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	8,895,617
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	9,072,697
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	8,895,614		Y

Expired US Patents for OSMOLEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	RE39069
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	RE39069
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018	RE39069

International Patents for OSMOLEX ER

See the table below for patents covering OSMOLEX ER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006089494
Japan	2007126478	MULTI-LAYERED PERMEATION DEVICE
China	1228020
Mexico	2007006472	DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.)
Brazil	PI0515761	dispositivo osmótico contendo amantadina e um sal osmótico
Japan	5325421
European Patent Office	1845968	COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE)

OSMOLEX ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OSMOLEX ER

Introduction

OSMOLEX ER, an extended-release oral medication containing amantadine, has been a significant player in the treatment of Parkinson's disease and managing uncontrolled movements. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Background

OSMOLEX ER was approved by the FDA in February 2018 for treating Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. This approval was based on data from Gocovri trials and bioavailability studies, demonstrating that the extended-release formulation delivers a similar amount of amantadine to the body as Gocovri[1][4].

Mechanism of Action

The drug's unique delivery system consists of an outer layer of amantadine that dissolves within 30 to 60 minutes after ingestion, followed by a consistent release of amantadine through a semipermeable tablet shell. This enables once-daily dosing, enhancing patient compliance[1].

Market Performance

Revenue Growth

OSMOLEX ER, along with other key products like Qelbree and GOCOVRI, has contributed significantly to Supernus Pharmaceuticals' revenue growth. In the third quarter of 2024, total revenues increased by 14% compared to the same period in 2023, largely due to the increased net sales of these products[2].

Product Sales

The net product sales of OSMOLEX ER, although not separately detailed, are part of the overall growth in CNS therapeutic products. For instance, in the nine months ended September 30, 2024, total net product sales were $471.3 million, up from $417.9 million in the same period in 2023. This growth is attributed to the strong performance of Qelbree and GOCOVRI, which includes OSMOLEX ER[2].

Financial Highlights

• Total Revenues: For the three and nine months ended September 30, 2024, total revenues were $175.7 million and $487.7 million, respectively, showing a 14% and 10% increase over the same periods in 2023[2].
• Operating Earnings: The operating earnings for the three and nine months ended September 30, 2024, were $40.9 million and $60.3 million, respectively, a significant improvement from the operating loss in the corresponding periods of 2023[2].
• Adjusted Operating Earnings: Adjusted operating earnings (non-GAAP) were $67.7 million and $135.4 million for the three and nine months ended September 30, 2024, indicating robust financial health[2].

Competitive Landscape

Market Penetration

The success of OSMOLEX ER is part of a broader trend of strong market penetration by Supernus Pharmaceuticals in the CNS therapeutic area. The significant year-over-year growth in net sales of Qelbree (129%) and GOCOVRI (15%) highlights the company's ability to successfully adopt and penetrate the market with these products[3].

Generic Erosion

While OSMOLEX ER and other Supernus products have seen growth, the decline in net product sales of Trokendi XR due to generic erosion is a notable challenge. However, the overall revenue growth indicates that the impact of generic competition is being offset by the performance of other key products[2][5].

Clinical and Market Significance

Bioequivalence and Efficacy

Studies have shown that OSMOLEX ER is bioequivalent to the reference listed drug (RLD), SYMMETREL® Syrup, in terms of AUCinf and Cmax at steady state. This bioequivalence supports the efficacy of OSMOLEX ER in managing Parkinson's disease symptoms and drug-induced extrapyramidal reactions[1][4].

Patient Compliance

The once-daily dosing regimen of OSMOLEX ER enhances patient compliance, which is crucial for managing chronic conditions like Parkinson's disease. This convenience factor contributes to its market appeal and adoption.

Future Outlook

Ongoing and Planned Studies

While specific future studies for OSMOLEX ER are not detailed, Supernus Pharmaceuticals is planning to initiate new studies for other products, indicating a continued commitment to research and development in the CNS therapeutic area. This proactive approach suggests a positive outlook for the company's product portfolio, including OSMOLEX ER[3].

Financial Projections

Given the strong financial performance and revenue growth, Supernus Pharmaceuticals is likely to continue its upward trajectory. The increase in cash, cash equivalents, and marketable securities to approximately $347.2 million as of June 30, 2024, provides a solid financial foundation for future growth and investment[5].

Key Takeaways

• Regulatory Approval: OSMOLEX ER was FDA-approved in February 2018 for treating Parkinson's disease and drug-induced extrapyramidal reactions.
• Market Performance: The drug has contributed to Supernus Pharmaceuticals' revenue growth, with total revenues increasing by 14% in the third quarter of 2024.
• Financial Health: Strong operating earnings and adjusted operating earnings indicate robust financial health.
• Competitive Landscape: Successful market penetration and offsetting generic erosion with other product sales.
• Clinical Significance: Bioequivalence to the RLD and once-daily dosing enhance patient compliance and efficacy.

FAQs

What is OSMOLEX ER used for?

OSMOLEX ER is used to ease symptoms of Parkinson's disease and manage uncontrolled movements, including drug-induced extrapyramidal reactions.

Who markets OSMOLEX ER?

OSMOLEX ER is currently marketed by Supernus Pharmaceuticals.

How does OSMOLEX ER work?

OSMOLEX ER has a unique delivery system with an immediate release outer layer and an extended-release core, allowing for once-daily dosing.

What are the approved dose strengths of OSMOLEX ER?

OSMOLEX ER is available in three dose strengths: 160 mg, 240 mg, and 320 mg.

How has the financial performance of Supernus Pharmaceuticals been impacted by OSMOLEX ER?

The financial performance has been positively impacted, with increased total revenues and operating earnings largely due to the strong sales of OSMOLEX ER and other key CNS products.

Sources

1. Parkinsons News Today: Osmolex ER (Amantadine): An Extended-Release Treatment for Parkinson's Disease and Uncontrolled Movements.
2. Supernus Pharmaceuticals: Supernus Announces Third Quarter 2024 Financial Results.
3. Stock Titan: Supernus Announces Fourth Quarter and Full Year 2023 Financial Results.
4. FDA: 209410Orig1s000 - accessdata.fda.gov.
5. GlobeNewswire: Supernus Announces Second Quarter 2024 Financial Results.