NAPROSYN Drug Patent Profile

When do Naprosyn patents expire, and when can generic versions of Naprosyn launch?

Naprosyn is a drug marketed by Atnahs Pharma Us and is included in two NDAs.

The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the naproxen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naprosyn

A generic version of NAPROSYN was approved as naproxen by GRANULES on December 21^st, 1993.

Summary for NAPROSYN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	44
Patent Applications:	4,572
Drug Prices:	Drug price information for NAPROSYN
What excipients (inactive ingredients) are in NAPROSYN?	NAPROSYN excipients list
DailyMed Link:	NAPROSYN at DailyMed

See drug prices for NAPROSYN

Recent Clinical Trials for NAPROSYN

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Shirley Ryan AbilityLab	Phase 2
Western University, Canada	N/A

See all NAPROSYN clinical trials

Pharmacology for NAPROSYN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for NAPROSYN

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	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	AB	RX	Yes	No
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-004	Apr 15, 1982	AB	RX	Yes	Yes
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for NAPROSYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982	3,998,966
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-004	Apr 15, 1982	3,998,966
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	3,904,682
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982	3,904,682

International Patents for NAPROSYN

See the table below for patents covering NAPROSYN around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S5011910
Switzerland	520645	Verfahren zur Herstellung von a-(2-Naphthyl)- bzw. a-(3,4-Dihydro-2-naphthyl)-a-difluormethylessigsäuren
United Kingdom	1301445
Spain	410167

Supplementary Protection Certificates for NAPROSYN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

NAPROSYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen (Naprosyn)

Introduction

Naproxen, commonly known by the brand name Naprosyn, is a non-steroidal anti-inflammatory drug (NSAID) widely used for treating various painful conditions, including arthritis, muscle strain, and back pain. The market dynamics and financial trajectory of naproxen are influenced by a complex array of factors, including supply chain disruptions, demand fluctuations, and economic conditions.

Global Market Size and Growth

The global non-steroidal anti-inflammatory drugs market, which includes naproxen, was valued at USD 19,551.54 million in 2021 and is projected to reach USD 31.45 billion by 2030, growing at a CAGR of 5.42% from 2022 to 2030[2].

Regional Market Trends

North America

In North America, the naproxen sodium market experienced a steady upward trajectory in prices due to supply constraints, elevated production costs, and geopolitical factors. Supply chain disruptions, natural disasters, and currency fluctuations contributed to these price increases. The U.S. market was particularly affected by supply chain disruptions originating from the Asia-Pacific region, such as severe congestion at Chinese ports and increased shipping costs[1].

Europe

The European market for naproxen sodium saw a decline in demand due to high inflation rates and a deteriorating economic scenario. Suppliers offered discounted rates to clear existing inventories, leading to unhealthy competition and lower prices. Despite efforts to increase prices, the weak demand dominated other market drivers[1].

Asia-Pacific

In the Asia-Pacific region, the prices of naproxen sodium fluctuated significantly. During the first half of 2023, prices rose due to increased orders from domestic and international buyers. However, by the third quarter, prices declined as supply chains normalized, and demand from international markets decreased. Producers reduced or halted production, but this did not significantly impact prices due to existing inventory levels[1].

Factors Influencing Market Dynamics

Supply Chain Disruptions

Supply chain bottlenecks, such as the Panama Canal drought and reduced vessel traffic, have escalated transportation costs and compounded the challenges faced by the naproxen market. These disruptions have led to higher production costs for U.S. drug manufacturers and tighter margins for distributors, resulting in higher prices for naproxen-based medications in retail pharmacies[1].

Demand Fluctuations

Demand for naproxen can fluctuate based on seasonal factors, such as the anticipation of colder months in Europe, which can increase demand for anti-inflammatory drugs. In contrast, subdued demand from end-users in the first quarter of 2024 led to a decline in naproxen API prices, although industry experts anticipate a rebound in demand and prices in the subsequent months[3].

Raw Material Costs

Fluctuations in raw material costs have a significant impact on the pricing of naproxen. For instance, the decline in naproxen API prices in the first quarter of 2024 was partly due to fluctuations in raw material costs. However, stabilization in these costs is expected to contribute to an upward trajectory in prices[3].

Economic Conditions

Economic factors such as inflation rates, currency fluctuations, and logistics challenges influence the market conditions for naproxen. High inflation rates in Europe, for example, have led to discounted rates and unhealthy competition among suppliers[1].

Financial Trajectory

Revenue and Sales

The U.S. annual sales for Naproxen Delayed-Release Tablets are approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data. This indicates a stable revenue stream for naproxen products in the U.S. market[5].

Market Segmentation

The non-steroidal anti-inflammatory drugs market, including naproxen, is segmented by disease indication, route of administration, and distribution channel. The arthritis segment holds the largest market share, and the oral segment dominates in terms of route of administration. Retail pharmacies account for the largest market share in distribution channels[2].

Growth Opportunities

The market is expected to grow due to the increasing geriatric population and the rise in arthritis cases. Naproxen's availability as a non-prescription drug and its well-established benefits and risks profile also drive market growth. The topical segment is expected to experience the fastest growth rate over the forecast period[2][4].

Challenges and Risks

Supply Chain Risks

The limited number of suppliers for active pharmaceutical ingredients (APIs) can result in lengthy delays in production if suppliers need to be changed. Supply chain disruptions, such as those caused by geopolitical conflicts or natural disasters, can also impact the availability and pricing of naproxen[5].

Regulatory Risks

Changes in FDA policies, guidelines, or actions, including drug recalls, can significantly affect the market. The ability of manufacturing partners to meet product demands and timelines is also a critical factor[5].

Quality and Safety Issues

Issues with product quality, manufacturing, or supply can impact patient safety and the overall market. The degradation of naproxen API due to exposure to high temperatures is a specific concern that can affect the drug's safety and efficacy[3].

Analyst Insights

According to Procurement Resource, the naproxen sodium market is poised for continued volatility due to global supply chain uncertainties and potential geopolitical and economic shifts. Analysts forecast that the price trend for naproxen sodium will likely oscillate in the coming quarter, influenced by market demand uncertainties and global economic conditions[1].

Key Takeaways

• The global non-steroidal anti-inflammatory drugs market, including naproxen, is projected to grow significantly by 2030.
• Regional market trends are influenced by supply chain disruptions, demand fluctuations, and economic conditions.
• Supply chain bottlenecks and raw material cost fluctuations significantly impact naproxen prices.
• The market is driven by the increasing geriatric population and the rise in arthritis cases.
• Regulatory and quality issues pose significant risks to the market.

FAQs

What are the key drivers of the naproxen market?

The key drivers include its availability as a non-prescription drug, well-established benefits and risks profile, fast-track development of new pharmaceutical industries, and the increase in geriatric population and arthritis cases[4].

How have supply chain disruptions affected the naproxen market?

Supply chain disruptions, such as congestion at Chinese ports and the Panama Canal drought, have led to higher production costs and tighter margins for distributors, resulting in higher prices for naproxen-based medications[1].

What is the expected growth rate of the non-steroidal anti-inflammatory drugs market?

The market is expected to grow at a CAGR of 5.42% from 2022 to 2030, reaching USD 31.45 billion by 2030[2].

Which segment holds the largest market share in the non-steroidal anti-inflammatory drugs market?

The arthritis segment holds the largest market share, and the oral segment dominates in terms of route of administration[2].

What are the potential risks associated with the naproxen market?

Potential risks include supply chain disruptions, regulatory changes, quality and safety issues, and economic uncertainties such as inflation and geopolitical conflicts[1][5].

Sources

1. Procurement Resource: Naproxen Sodium Price Trend and Forecast.
2. BioSpace: Non-steroidal Anti-inflammatory Drugs Market Size USD 31.45 Billion by 2030.
3. ChemAnalyst: Navigating Naproxen Prices: Anticipating a Q2 Upswing in the US Market.
4. Transparency Market Research: Naproxen Market Insight and Trends 2024.
5. ANI Pharmaceuticals: ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets.