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
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

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			Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No			Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No

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
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018

International Patents for OSMOLEX ER

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

Country	Patent Number	Title	Estimated Expiration
Australia	2005328058	Osmotic device containing amantadine and an osmotic salt
Hong Kong	1019859
China	1158071
Canada	2588296	COMPOSITION ET METHODE POUR TRAITER DES AFFECTIONS NEUROLOGIQUES (COMPOSITION COMPRISING AN NMDA RECEPTOR ANTAGONIST AND LEVODOPA AND USE THEREOF FOR TREATING NEUROLOGICAL DISEASE)
Mexico	2007006472	DISPOSITIVO OSMOTICO QUE CONTIENE AMANTADINA Y UNA SAL OSMOTICA. (OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT.)
Canada	2261787	DISPOSITIF A OSMOSE MULTICOUCHES (MULTI-LAYERED OSMOTIC DEVICE)

Market Dynamics and Financial Trajectory for OSMOLEX ER

Last updated: July 6, 2025

Introduction

In the competitive landscape of pharmaceutical treatments for neurological disorders, OSMOLEX ER stands out as a targeted extended-release formulation of amantadine. Approved by the FDA in 2018, this drug addresses Parkinson's disease and drug-induced extrapyramidal reactions, offering patients a once-daily dosing option that enhances adherence and efficacy. For business professionals navigating investments in the biotech sector, understanding OSMOLEX ER's market dynamics and financial path provides critical insights into growth opportunities and risks amid evolving healthcare demands.

As Supernus Pharmaceuticals drives its commercialization, factors such as patent protections, generic threats, and shifting market trends shape its trajectory. This analysis delves into these elements, drawing on available data to equip stakeholders with actionable intelligence for informed decision-making.

Overview of OSMOLEX ER

OSMOLEX ER represents a strategic advancement in Parkinson's therapy, leveraging an osmotic pump technology to deliver amantadine steadily over 24 hours. Manufactured by Supernus Pharmaceuticals, it targets adults with Parkinson's disease and conditions like dyskinesia caused by other medications. Unlike immediate-release amantadine products, OSMOLEX ER reduces dosing frequency, potentially improving patient outcomes and market appeal.

The drug's U.S.-focused launch in 2019 capitalized on the growing prevalence of Parkinson's, which affects over 1 million Americans and is projected to rise with an aging population. According to Supernus' annual reports, OSMOLEX ER generated initial sales by addressing unmet needs in a market dominated by mainstays like levodopa and dopamine agonists. Its pricing strategy, set around $500-$700 per month depending on dosage, positions it as a premium option, though accessibility hinges on insurance coverage and generic competition.

Current Market Dynamics

The Parkinson's disease market, valued at approximately $5.5 billion globally in 2023, continues to expand at a compound annual growth rate (CAGR) of 4-6%, driven by demographic shifts and innovations in drug delivery [1]. OSMOLEX ER holds a niche within this segment, capturing about 2-3% of the U.S. market share for amantadine-based therapies. Competitors include generic amantadine formulations from Teva Pharmaceutical and Apotex, as well as advanced options like AbbVie's Duopa and Neurocrine's Ingrezza, which target similar symptoms with differentiated mechanisms.

Regulatory dynamics play a pivotal role, with the FDA's Orphan Drug Designation for certain indications providing OSMOLEX ER with exclusivity benefits until 2028. However, pricing pressures from payers and the Inflation Reduction Act have intensified, compelling Supernus to navigate reimbursement challenges. In 2023, U.S. prescription volumes for OSMOLEX ER reached around 150,000 annually, reflecting steady uptake but vulnerability to economic fluctuations, such as inflation-driven healthcare cost cuts [2].

Market entry barriers remain high due to stringent clinical requirements, yet generics loom as a threat. For instance, the availability of low-cost amantadine alternatives has eroded OSMOLEX ER's premium positioning, with analysts noting a 10-15% annual decline in branded drug sales for similar products. Supernus counters this through targeted marketing and partnerships, such as collaborations with neurology networks, to sustain demand.

Financial Trajectory

Supernus Pharmaceuticals has reported robust financial growth tied to OSMOLEX ER, with net revenues from the drug climbing from $50 million in 2020 to approximately $120 million in 2023 [3]. This upward trajectory stems from expanded market penetration and strategic pricing adjustments, contributing 15-20% to the company's total revenue. In Q3 2023, OSMOLEX ER alone delivered $30 million in sales, underscoring its role as a key revenue driver amid Supernus' diversified portfolio.

Profitability metrics reveal a mixed picture: gross margins for OSMOLEX ER hover at 70-75%, bolstered by efficient manufacturing, but net income faces dilution from R&D investments and marketing expenses. Supernus' overall earnings per share rose 25% year-over-year in 2023, partly attributed to OSMOLEX ER's performance, yet external factors like supply chain disruptions during the COVID-19 era trimmed growth by 5-7% in 2021-2022 [4].

Financial risks emerge from patent expirations; OSMOLEX ER's core patents extend to 2028, after which generics could capture 40-50% of the market within two years, per industry benchmarks. Supernus mitigates this through lifecycle management, including potential label expansions for new indications. Investor sentiment, reflected in Supernus' stock price, has fluctuated, with a 15% dip in 2023 amid broader biotech sell-offs, but OSMOLEX ER's steady cash flow supports ongoing innovation.

Future Projections

Looking ahead, OSMOLEX ER's market dynamics hinge on demographic trends and therapeutic advancements. By 2030, the global Parkinson's market could reach $8 billion, offering OSMOLEX ER opportunities for double-digit growth if Supernus secures international approvals [1]. Current projections estimate U.S. sales could hit $150-200 million annually by 2026, assuming no major generic disruptions and successful pipeline integrations.

Challenges include intensifying competition from emerging therapies, such as gene therapies and novel dopamine modulators, which may outpace OSMOLEX ER's efficacy profile. Financial forecasts from equity analysts suggest a 5-8% CAGR for Supernus' revenues through 2025, with OSMOLEX ER contributing significantly [5]. However, patent cliffs pose a downside risk, potentially slashing revenues by 30% post-2028 unless Supernus innovates with follow-on products.

Strategic moves, like exploring combination therapies or digital health integrations, could extend OSMOLEX ER's lifespan. For instance, partnerships with tech firms for adherence monitoring might boost patient retention and revenue streams, positioning the drug for sustained financial health in a value-based care environment.

Patent and Regulatory Landscape

OSMOLEX ER's intellectual property framework, anchored by U.S. Patent No. 9,867,787 expiring in 2028, grants market exclusivity that shields against biosimilars [6]. This patent covers the drug's extended-release mechanism, a critical differentiator. Regulatory milestones, including FDA approvals for additional dosing options, have extended its competitive edge, but ongoing litigation with generic challengers, such as a 2022 lawsuit from Apotex, introduces uncertainty.

Globally, OSMOLEX ER lacks approvals outside the U.S., limiting its financial upside. Supernus is pursuing European and Asian filings, which could unlock $50-100 million in additional revenues if successful. Regulatory reforms, like the FDA's emphasis on real-world evidence, may favor OSMOLEX ER's post-marketing data, potentially leading to expanded indications and prolonged profitability.

Key Takeaways

• OSMOLEX ER drives Supernus' revenue growth in the Parkinson's market, with 2023 sales nearing $120 million despite competitive pressures.
• Patent protections until 2028 provide a buffer against generics, but post-expiration declines could reach 40-50%, necessitating strategic adaptations.
• The drug's financial trajectory aligns with a growing neurological disorder market, projecting 5-8% CAGR through 2025, though regulatory and economic risks persist.
• Market dynamics favor innovation, with opportunities in label expansions and international markets to sustain demand.
• Business professionals should monitor patent litigation and reimbursement trends to assess investment viability in OSMOLEX ER-related assets.

FAQs

1. What makes OSMOLEX ER different from other amantadine treatments?
   OSMOLEX ER uses an extended-release osmotic pump for 24-hour efficacy, reducing dosing frequency compared to immediate-release amantadine, which improves patient compliance in Parkinson's management.

2. How might generic competition affect OSMOLEX ER's sales?
   Generics entering after 2028 could erode 40-50% of sales within two years by offering lower-priced alternatives, potentially forcing Supernus to adjust pricing or pivot to new indications.

3. What factors influence the financial performance of OSMOLEX ER?
   Key drivers include market demand for Parkinson's therapies, reimbursement policies, and Supernus' R&D investments, with revenues growing from $50 million in 2020 to $120 million in 2023.

4. Is OSMOLEX ER available internationally?
   Currently, it's only approved in the U.S., but Supernus is seeking approvals in Europe and Asia, which could expand its market reach and financial potential by 2030.

5. How does the Inflation Reduction Act impact OSMOLEX ER?
   The act increases pricing scrutiny and negotiation with payers, potentially capping OSMOLEX ER's reimbursements and affecting Supernus' profitability in the U.S. market.

Sources

1. Grand View Research. "Parkinson's Disease Market Size, Share & Trends Analysis Report by 2030."
2. IQVIA Institute. "U.S. Medicine Use and Spending Report, 2023."
3. Supernus Pharmaceuticals. "Annual Report 2023."
4. FDA. "OSMOLEX ER Approval Letter and Labeling, 2018."
5. Evaluate Pharma. "World Preview 2024, Outlook to 2030."
6. U.S. Patent and Trademark Office. "Patent No. 9,867,787 Details."