ANAPROX DS Drug Patent Profile

When do Anaprox Ds patents expire, and what generic alternatives are available?

Anaprox Ds is a drug marketed by Atnahs Pharma Us and is included in one NDA.

The generic ingredient in ANAPROX DS is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and twenty-nine suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Anaprox Ds

A generic version of ANAPROX DS was approved as naproxen sodium by ADAPTIS on January 13^th, 1997.

Summary for ANAPROX DS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	13
Patent Applications:	5,828
Drug Prices:	Drug price information for ANAPROX DS
DailyMed Link:	ANAPROX DS at DailyMed

See drug prices for ANAPROX DS

Recent Clinical Trials for ANAPROX DS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Northwestern Medical Group	Phase 2
Shirley Ryan AbilityLab	Phase 2
Apkar Apkarian	Phase 4

See all ANAPROX DS clinical trials

US Patents and Regulatory Information for ANAPROX DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	AB	RX	Yes	Yes

Expired US Patents for ANAPROX DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	3,998,966
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	4,009,197
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	4,001,301

International Patents for ANAPROX DS

See the table below for patents covering ANAPROX DS around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2013641
United Kingdom	1301816
France	1587861

Supplementary Protection Certificates for ANAPROX DS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126

Market Dynamics and Financial Trajectory for ANAPROX DS

Last updated: July 31, 2025

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Introduction

ANAPROX DS, a formulation often associated with naproxen sodium, positions itself within the analgesic and anti-inflammatory drug segment, targeting conditions such as osteoarthritis, rheumatoid arthritis, and acute pain management. Understanding its market potential entails analyzing current demand drivers, competitive landscape, patent status, manufacturing trends, and regulatory environment. This comprehensive overview provides insights into how market forces are shaping ANAPROX DS’s financial trajectory.

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Market Overview and Demand Drivers

The global demand for non-steroidal anti-inflammatory drugs (NSAIDs) has experienced consistent growth, driven by increasing prevalence of chronic inflammatory diseases, aging populations, and heightened awareness of pain management options. According to a report from Grand View Research, the NSAID market was valued at USD 16.4 billion in 2021 and expected to grow at a CAGR of 4.3% through 2030 [1].

Naproxen sodium, the active ingredient in ANAPROX DS, benefits from a well-established safety and efficacy profile, reinforcing its demand among healthcare providers. The over-the-counter (OTC) availability of similar formulations further enhances accessibility, though regulatory restrictions on strength and indications influence overall market size.

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Competitive Landscape

The NSAID market is highly competitive, with key players including Bayer (Aleve), Pfizer (Anaprox), and generic pharmaceutical manufacturers. Established brands benefit from consumer familiarity and extensive distribution networks. ANAPROX DS competes both in prescription and OTC sectors, requiring strategic positioning to capitalize on growing pain management needs.

Innovations such as extended-release formulations or combination therapies can influence competitive advantage. Additionally, patent expirations for older naproxen formulations have led to a surge in generic entries, intensifying price competition.

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Regulatory and Patent Landscape

Patent protection significantly influences ANAPROX DS’s financial outlook. Currently, if patents for specific formulations or delivery mechanisms are active, exclusivity can favor pricing power and market share. Conversely, patent expirations or challenges open pathways for generic incorporation, compressing margins.

Regulatory approval processes for new indications or formulations could unlock new markets. For instance, expanding indications to encompass juvenile arthritis or osteoarthritis could elevate revenue streams. However, logistical and clinical trial costs associated with such approvals must be considered.

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Manufacturing and Supply Chain Considerations

Manufacturing efficiency and supply chain resilience are key to maintaining profit margins. Trends towards outsourcing production to cost-effective geographies, while managing regulatory compliance, have gained prominence.

Global disruptions, such as the COVID-19 pandemic, exposed vulnerabilities in supply chains. Manufacturers investing in diversified sourcing and inventory management are better positioned to meet rising demand without interruptions, influencing the financial robustness of ANAPROX DS.

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Pricing and Market Penetration Strategies

Pricing strategies revolve around balancing profitability and market share. Premium pricing can be sustained if ANAPROX DS distinguishes itself with superior formulation, reduced side effects, or expanded indications. However, the dominance of generics exerts downward pressure on prices, compelling companies to innovate or differentiate.

Market penetration hinges on strategic marketing, physician education, pharmacovigilance, and patient adherence. Demonstrating safety and efficacy for specific indications fosters prescriber confidence, expanding usage.

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Future Growth Opportunities and Challenges

Opportunities:

1. Expanding Indications: Broadened-approved uses can propel sales, especially in chronic pain conditions or pediatric populations.
2. Geographical Expansion: Emerging markets in Asia-Pacific and Latin America exhibit rising healthcare spending and demand for NSAIDs.
3. Formulation Innovations: Development of sustained-release formulations reduces dosing frequency, enhancing patient compliance.

Challenges:

1. Regulatory Risks: Stringent safety evaluations and possible adverse event disclosures could impact approval timelines and market access.
2. Pricing Wars: Intense competition with generics caps pricing premiums.
3. Market Saturation: Mature markets nearing saturation may limit growth unless differentiated offerings are introduced.

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Financial Trajectory Analysis

A preliminary financial forecast indicates steady revenue growth aligned with broader NSAID market trends. The key determinants include:

• Market Penetration Rate: The share of targeted indications and geographical markets.
• Pricing Strategy: Ability to command premiums versus generic competitors.
• Manufacturing Costs: Operational efficiencies and economies of scale.
• Regulatory Milestones: Approval of new indications or formulations.

Assuming successful expansion and maintenance of market share, a CAGR of 3-5% over the next five years appears feasible. Revenue streams will likely stabilize in saturated markets unless significant innovation or market expansion occurs.

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Impact of Patent Status and Innovation

Patent exclusivity remains pivotal. If the formulation or delivery mechanism for ANAPROX DS is protected until 2030, the drug can sustain higher margins. Conversely, patent cliffs could lead to rapid erosion of revenues by generics, necessitating continuous innovation.

Investments in novel delivery systems—such as transdermal patches or long-acting formulations—could extend market exclusivity and augment revenue potential. These innovations often attract premium pricing and expand indication possibilities.

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Key Market Trends Shaping Financial Outcomes

• Shift towards OTC availability: While increasing accessibility, OTC switches restrict pricing power, pressure margins.
• Personalized medicine: Tailoring NSAID therapy based on genetic and clinical profiles could improve efficacy and reduce adverse effects, supporting premium pricing.
• Emerging markets growth: Rapid urbanization and healthcare investments in developing regions offer substantial sales opportunities.

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Conclusion

ANAPROX DS's financial future hinges on balancing competitive pressures, regulatory landscapes, and innovative development strategies. While mature markets pose pricing and patent challenges, expanding indications, geographical reach, and formulation innovations present pathways to sustain and grow revenues. Strategic investments and patent management are critical in navigating the complex pharmaceutical landscape.

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Key Takeaways

• Market growth is steady but competitive: Positioning through innovation and differentiation is essential to capitalize on rising NSAID demand.
• Patent protection drives profitability: Maintaining exclusivity with formulations and delivery methods directly influences revenue.
• Geographical and indication expansion offer viable growth avenues: Penetrating emerging markets and securing approvals for new uses amplifies sales.
• Supply chain resilience impacts margins: Ensuring manufacturing efficiency and supply stability underpins financial stability.
• Pricing strategy is crucial: Balancing premium pricing with generic competition determines profitability.

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FAQs

1. How does patent expiration impact ANAPROX DS’s market share?
Patent expirations expose ANAPROX DS to generic competition, often leading to significant price erosion and reduced profit margins. Strategic patent filings on formulations or delivery mechanisms can delay this impact and sustain market share.

2. What are the key factors driving demand for ANAPROX DS?
Growing prevalence of chronic inflammatory diseases, aging populations, and increased awareness of pain management contribute to sustained demand for NSAIDs like ANAPROX DS.

3. How can manufacturing innovation influence ANAPROX DS’s financial trajectory?
Innovations that improve production efficiency or create differentiated formulations can reduce costs, extend patent life, and allow premium pricing, positively impacting revenues.

4. What role do regulatory approvals play in the drug’s market expansion?
Regulatory approvals for new indications or formulations can unlock additional revenue streams and expand market reach; however, they require investment and time, with risks of delays or rejections.

5. Which emerging markets offer growth opportunities for ANAPROX DS?
Countries in Asia-Pacific and Latin America experience increasing healthcare expenditure and demand for NSAIDs, presenting substantial growth prospects with the right market entry strategies.

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Sources

[1] Grand View Research, "NSAID Market Size, Share & Trends Analysis Report," 2022.