NAPRELAN Drug Patent Profile

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

Naprelan is a drug marketed by Twi Pharms and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naprelan

A generic version of NAPRELAN was approved as naproxen sodium by CONTRACT PHARMACAL on January 13^th, 1997.

Summary for NAPRELAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	8
Patent Applications:	6,075
Drug Prices:	Drug price information for NAPRELAN
Drug Sales Revenues:	Drug sales revenues for NAPRELAN
What excipients (inactive ingredients) are in NAPRELAN?	NAPRELAN excipients list
DailyMed Link:	NAPRELAN at DailyMed

See drug prices for NAPRELAN

See drug sales revenues for NAPRELAN

Recent Clinical Trials for NAPRELAN

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Apkar Apkarian	Phase 4
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 4

See all NAPRELAN clinical trials

Pharmacology for NAPRELAN

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

US Patents and Regulatory Information for NAPRELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes

Expired US Patents for NAPRELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	5,637,320
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	5,637,320
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	5,637,320

International Patents for NAPRELAN

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

Country	Patent Number	Title	Estimated Expiration
Israel	96900	Controlled release pharmaceutical composition containing pelletized naproxen
Ireland	900149
Canada	2034096	FORMULATION DE NAPROXENE A LIBERATION CONTROLEE POUR ADMINISTRATION UNE FOIS PAR JOUR (CONTROLLED ABSORPTION NAPROXEN FORMULATION FOR ONCE-DAILY ADMINISTRATION)
South Africa	9100274

Supplementary Protection Certificates for NAPRELAN

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

NAPRELAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen Sodium (Naprelan)

Introduction

Naproxen sodium, commonly known by the brand name Naprelan, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for treating pain, inflammation, and various musculoskeletal conditions. The market dynamics and financial trajectory of naproxen sodium are influenced by a complex interplay of factors, including demand from downstream industries, production costs, supply chain disruptions, and economic conditions.

Global Demand and Market Trends

Europe

In the European market, particularly in Germany, the demand for naproxen sodium has been significant, although it has faced fluctuations. High inflation rates and a deteriorating economic scenario have led to dwindling demand, prompting suppliers to offer discounted rates to clear inventories. This has resulted in unhealthy competition and lower prices despite efforts to maintain or increase them[1].

North America

The North American market has experienced a steady increase in naproxen sodium prices, driven by supply constraints, elevated production costs, and geopolitical factors. Supply chain disruptions, natural disasters, and currency fluctuations have contributed to these price increases. The market has shown resilience, with a consistent upward trend reflecting tight supply conditions and robust demand[1].

Asia-Pacific

In the Asia-Pacific region, the price trend for naproxen sodium has been volatile. During the third quarter of 2023, prices were at the lower end due to reduced upstream cost pressure and normalization of supply chains. However, the decline in international market demands impacted production rates, leading to no significant change in prices despite production cuts[1].

Factors Influencing Market Dynamics

Supply Chain Disruptions

Supply chain bottlenecks, such as congestion at Chinese ports and the Panama Canal drought, have significantly impacted the transportation costs and availability of naproxen sodium. These disruptions have led to higher production costs for U.S. drug manufacturers and tighter margins for distributors, resulting in higher retail prices[1].

Production Costs

The escalating cost of production, influenced by raw material costs and manufacturing expenses, has been a key driver of the price trend for naproxen sodium. Rising production costs in key producing nations have contributed to substantial price increases, particularly in the U.S. market[1].

Economic and Geopolitical Factors

Economic factors, including currency fluctuations and geopolitical tensions, have played a crucial role in shaping the market dynamics. The mixed signals from the U.S. economy, with manufacturing contracting while the services sector expanded, have further influenced the market[1].

Seasonal Demand

Seasonal demand, particularly the anticipation of colder months, has also impacted the price dynamics of naproxen sodium. In regions like Europe, the demand tends to increase during colder months, which can drive up prices[1].

Financial Trajectory

Revenue and Profitability

The financial performance of companies involved in the production and distribution of naproxen sodium is closely tied to the market dynamics. For instance, supply chain disruptions and increased production costs can lead to higher costs and potentially lower profitability if demand does not keep pace with price increases[1].

Forecast and Projections

Analysts predict continued volatility in the naproxen sodium market due to ongoing global supply chain uncertainties and potential geopolitical and economic shifts. Despite this, there is cautious optimism about a modest rebound in demand and prices, particularly in the U.S. market, driven by renewed demand from pharmaceutical companies and stabilization in raw material costs[3].

Impact of Market Dynamics on Pharmaceutical Industry

Pharmaceutical Demand

The demand for naproxen sodium from the pharmaceutical sector is a significant driver of the market. The fast-track development of new pharmaceutical industries and the increasing geriatric population, which leads to a rise in arthritis cases, have propelled the demand for naproxen sodium[4].

Inventory Management

Inventory management plays a critical role in the market dynamics. Merchants often focus on reducing inventories to prevent the expiration and degradation of naproxen API, especially during periods of high temperatures. This strategic inventory management can contribute to the upward trajectory of naproxen API prices[3].

Analyst Insights

Market Volatility

Analysts from Procurement Resource and ChemAnalyst highlight the volatility in the naproxen sodium market, attributing it to global supply chain uncertainties, economic shifts, and geopolitical factors. These uncertainties are expected to continue influencing the market in the coming quarters[1][3].

Future Outlook

Despite the current challenges, there is an anticipation of a modest rebound in the market. Increased market activity, strategic inventory management, and stabilization in raw material costs are expected to drive this rebound. This underscores the resilience of the pharmaceutical supply chain and its ability to adapt to changing market conditions[3].

Key Takeaways

• Global Demand: The demand for naproxen sodium varies by region, with Europe facing dwindling demand due to economic conditions, while North America experiences steady demand.
• Supply Chain: Disruptions in supply chains significantly impact the availability and pricing of naproxen sodium.
• Production Costs: Rising production costs, influenced by raw materials and manufacturing expenses, drive price increases.
• Economic Factors: Economic and geopolitical factors, including currency fluctuations and mixed economic signals, influence market dynamics.
• Seasonal Demand: Seasonal variations in demand, particularly during colder months, affect price trends.
• Financial Performance: The financial performance of companies is closely tied to market dynamics, with volatility expected to continue.
• Future Outlook: Despite current challenges, a modest rebound is anticipated due to renewed demand and stabilization in raw material costs.

FAQs

What are the primary drivers of the naproxen sodium market?

The primary drivers include its availability as a non-prescription drug, well-established profiling of its benefits and risks, and the fast-track development of new pharmaceutical industries. Additionally, the increasing geriatric population and rise in arthritis cases propel the market[4].

How do supply chain disruptions affect the naproxen sodium market?

Supply chain disruptions, such as congestion at Chinese ports and the Panama Canal drought, increase transportation costs and impact the availability of naproxen sodium, leading to higher production costs and tighter margins for distributors[1].

What is the impact of economic factors on the naproxen sodium market?

Economic factors, including currency fluctuations and geopolitical tensions, significantly influence the market dynamics. Mixed economic signals, such as manufacturing contraction and services sector expansion, also affect the market[1].

How does seasonal demand influence the naproxen sodium market?

Seasonal demand, particularly the anticipation of colder months, increases demand for naproxen sodium, which can drive up prices in regions like Europe[1].

What is the anticipated future outlook for the naproxen sodium market?

Analysts anticipate a modest rebound in the market due to renewed demand from pharmaceutical companies and stabilization in raw material costs. This rebound underscores the resilience of the pharmaceutical supply chain and its ability to adapt to changing market conditions[3].

How does inventory management affect the naproxen API market?

Inventory management is crucial as merchants focus on reducing inventories to prevent the expiration and degradation of naproxen API, especially during periods of high temperatures. This strategic management can contribute to the upward trajectory of naproxen API prices[3].

Sources

1. Procurement Resource: Naproxen Sodium Price Trend and Forecast.
2. Shionogi: Financial Results - Shionogi.
3. ChemAnalyst: Navigating Naproxen Prices: Anticipating a Q2 Upswing in the US Market.
4. Transparency Market Research: Naproxen Market Insight and Trends 2024.
5. Shionogi: Financial Results for Fiscal Year 2014 (Consolidated) - Shionogi Inc.