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-five 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

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	209410-002	Feb 16, 2018
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018
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	209410-003	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
Japan	5325421
World Intellectual Property Organization (WIPO)	2006089494
Spain	2549581
Spain	2203963
Argentina	007358	UN DISPOSITIVO OSMOTICO MULTICAPA PARA EL SUMINISTRO CONTROLADO DE UNO O MAS AGENTES ACTIVOS A UNO O MAS AMBIENTES DE USO.

Market Dynamics and Financial Trajectory for OSMOLEX ER

Last updated: July 29, 2025

Introduction

OSMOLEX ER, a proprietary extended-release formulation of oxymetazoline, is positioned in the nasal decongestant market, capitalizing on the growing prevalence of respiratory ailments and increasing consumer preference for self-medication. This analysis delineates the evolving market landscape, regulatory environment, competitive positioning, and financial prospects of OSMOLEX ER, offering crucial insights for industry stakeholders aiming to gauge its commercial viability and strategic growth potential.

Market Dynamics

Epidemiological and Consumer Trends

The global respiratory disease burden continues to rise due to factors such as urbanization, pollution, and increased awareness of allergic and sinus conditions. The nasal decongestant segment is witnessing sustained demand driven by common colds, allergic rhinitis, and sinusitis, especially during seasonal peaks. As per WHO estimates, respiratory diseases account for approximately 4.2 million deaths annually, highlighting a persistent need for effective symptomatic relief [1].

Consumers increasingly favor convenient, rapid-onset therapies with minimal side effects. Extended-release formulations like OSMOLEX ER align with these preferences by providing longer-lasting relief, reducing dosing frequency, and enhancing compliance. This demand for improved pharmacokinetics underscores the strategic importance of OSMOLEX ER in the portfolio.

Regulatory and Patent Landscape

Regulatory frameworks for nasal decongestants have tightened, emphasizing safety profiles and abuse potential, especially with sympathomimetics like oxymetazoline. OSMOLEX ER's extended-release platform necessitates rigorous clinical evaluation to demonstrate bioequivalence, safety, and efficacy. Patent protections for proprietary formulations serve as critical barriers against generic competition, affording potential exclusivity periods that can influence commercial viability.

Patent landscapes reveal a complex web, with key patents protecting critical formulation attributes such as sustained-release mechanisms, olfactory membrane permeability, and delivery device innovations [2]. Navigating these IP rights is vital for strategic market entry and longevity.

Competitive Environment

The market hosts several established players—Pfizer’s Dristan, Allergan’s Flonase, and Azelastine-based products—each with entrenched consumer bases. However, the extended-release paradigm offers differentiation through prolonged symptom control and reduced dosing. Competitors are exploring similar technology platforms, signaling a trend toward innovation-driven competition.

Emerging generics and biosimilars threaten market share intensification. Nonetheless, proprietary platforms like OSMOLEX ER may sustain competitive advantage via patent exclusivity and formulation advantages. Strategic collaborations and licensing agreements could further expand reach and reinforce market positioning.

Distribution and Market Penetration

Distribution channels encompass OTC pharmacies, drugstores, online platforms, and healthcare providers. The increasing acceptance of self-medication, particularly in mature markets like North America and Europe, supports rapid adoption of OSMOLEX ER.

Market penetration is also influenced by regional healthcare policies, reimbursement frameworks, and consumer awareness campaigns. For instance, regulatory incentives for OTC products in the U.S. facilitate entry, while price sensitivity in emerging markets necessitates tiered pricing strategies.

Financial Trajectory

Revenue Projections and Market Size

The global nasal decongestant market was valued at $5.8 billion in 2022 and is projected to grow at a CAGR of approximately 4.1% through 2030, propelled by rising cases of allergic and viral sinusitis [3]. OSMOLEX ER's potential market share hinges on successful regulatory approvals, pricing strategies, and physician and consumer acceptance.

Assuming a conservative market penetration of 10% within the extended-release niche, initial revenues could approximate $100 million within five years post-launch, with possibilities for expansion via geographic and clinical indications.

Cost Structure and Profitability

Research and development (R&D) investments for formulation development, clinical trials, and regulatory submissions are substantial. Estimated R&D expenditure for novel extended-release nasal sprays ranges from $50-100 million, depending on development scale and clinical trial scope [4].

Manufacturing costs are affected by formulation complexity, quality control measures prevalent in nasal delivery systems, and scale economies. Bulk production could reduce per-unit costs, improving profit margins.

Pricing strategies play a pivotal role, with premium positioning justified by extended relief benefits. An optimal price point would balance market competitiveness with sustainable margins.

Regulatory Milestones and Profit Timeline

Achieving FDA and EMA approvals transitions the product from development to commercialization, marking key revenue inflection points. Post-approval, significant marketing investments are necessary to educate clinicians and consumers, impacting short-term profitability.

Long-term profitability depends on sustained patent protection, minimal generic competition, and expanding indications, such as in post-surgical or hospital settings.

Risks and Uncertainties

Market entry risks include regulatory delays, formulation challenges, unforeseen adverse events, and competitive responses. Price erosion from generics, evolving regulatory standards, and shifts in consumer preferences pose ongoing threats. Furthermore, unforeseen macroeconomic factors, such as supply chain disruptions, may impact financial plans.

Strategic Implications

For stakeholders, investing in OSMOLEX ER demands a nuanced approach, emphasizing robust clinical data to substantiate benefits, strategic IP management, and targeted marketing. Partnering with key distributors and healthcare providers can accelerate market penetration, while geographic diversification mitigates regional regulatory or competitive risks.

Key Takeaways

• The nasal decongestant market exhibits steady growth driven by rising respiratory illnesses and consumer demand for extended relief formulations.

• Proprietary extended-release platforms like OSMOLEX ER can create competitive advantages, especially if protected by strong patents and supported by robust clinical data.

• Financial success relies on successful regulatory navigation, strategic pricing, and effective distribution channels, with initial revenues potentially reaching hundreds of millions within five years.

• Competitive pressures from biosimilars and generics underscore the importance of differentiated formulations and ongoing innovation.

• Risk management strategies—such as IP protection, diversified markets, and adaptive marketing—are crucial to realizing long-term profitability.

FAQs

1. What distinguishes OSMOLEX ER from traditional oxymetazoline nasal sprays?
OSMOLEX ER employs an extended-release formulation that prolongs symptomatic relief, reducing dosing frequency and improving patient compliance compared to immediate-release formulations.

2. What patent protections are relevant for OSMOLEX ER?
Patent protections typically cover proprietary formulation techniques, sustained-release mechanisms, delivery devices, and methods of manufacture, granting exclusivity that can extend up to 20 years from filing.

3. How does regulatory approval impact the financial trajectory of OSMOLEX ER?
Regulatory approval is a pivotal milestone; delays or denials can postpone or prevent market entry, thereby affecting projected revenues and return on investment.

4. What are the main risks facing the commercialization of OSMOLEX ER?
Risks include formulation development hurdles, safety and efficacy concerns, competitive responses, patent challenges, and market acceptance issues.

5. Which markets offer the highest growth potential for OSMOLEX ER?
North America and Europe offer mature, high-volume markets with favorable OTC regulations, while emerging markets in Asia and Latin America present opportunities for expansion with tailored strategies.

References

[1] World Health Organization. (2022). The global burden of respiratory diseases. WHO Publications.

[2] Patent landscape analysis reports. (2022). Extended-release nasal decongestant formulations.

[3] Grand View Research. (2022). Nasal Spray Market Size, Share & Trends Analysis.

[4] Deloitte Pharmaceutical R&D Cost Reports. (2021). Innovation and Investment Trends in Nasal Drug Delivery.

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