ANAPROX Drug Patent Profile

Which patents cover Anaprox, and when can generic versions of Anaprox launch?

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

The generic ingredient in ANAPROX 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 Anaprox

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

Summary for ANAPROX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	13
Patent Applications:	4,415
Drug Prices:	Drug price information for ANAPROX
DailyMed Link:	ANAPROX at DailyMed

See drug prices for ANAPROX

Recent Clinical Trials for ANAPROX

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 clinical trials

Pharmacology for ANAPROX

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

US Patents and Regulatory Information for ANAPROX

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	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	AB	RX	Yes	Yes

Expired US Patents for ANAPROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	3,998,966
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	4,009,197
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	4,001,301

International Patents for ANAPROX

See the table below for patents covering ANAPROX 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

Supplementary Protection Certificates for ANAPROX

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

ANAPROX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen Sodium (ANAPROX)

Introduction

Naproxen sodium, commonly known by the brand name ANAPROX, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for managing pain, menstrual cramps, and inflammatory conditions such as osteoarthritis and rheumatoid arthritis. The market dynamics and financial trajectory of naproxen sodium are influenced by a complex interplay of supply chain factors, economic conditions, and demand from downstream industries.

Global Market Overview

The global naproxen market is segmented by formulation, disease indication, and distribution channel. Key regions include North America, Europe, and the Asia-Pacific, each exhibiting distinct trends driven by local demand, supply chain conditions, and economic factors[2][4].

Regional Market Trends

North America

In North America, particularly in the U.S., the naproxen sodium market has seen a steady upward trajectory in prices due to supply constraints, elevated production costs, and geopolitical factors. Supply chain disruptions, natural disasters, and currency fluctuations have significantly impacted the market, leading to higher production costs and tighter margins for distributors. As of Q1 2024, the price in the U.S. was around $35,550 USD/MT[1][2].

Europe

The European market, led by Germany, has experienced price fluctuations. Initial price increases were driven by local demand and low availability, but later declined due to increased imports from China and reduced market inquiries. High inflation rates and a deteriorating economic scenario have also contributed to dwindling demand, leading suppliers to offer discounted rates and creating unhealthy competition in the market[1][2].

Asia-Pacific

In the Asia-Pacific region, the market saw an upward trend in the first half of 2023 due to rising orders from domestic sectors and increased market activities in China. However, prices declined in the first quarter of 2024 due to subdued demand and surplus inventories. The normalization of supply chains and reduced upstream cost pressure have also contributed to the lower price trend in this region[1][2].

Supply Chain and Economic Factors

Supply chain disruptions, such as severe congestion at Chinese ports and the Panama Canal drought, have escalated transportation costs and compounded the challenges faced by the naproxen market. These disruptions, coupled with geopolitical factors and economic uncertainties, have led to higher production costs and tighter margins for distributors[1][2].

Demand and Market Drivers

The demand for naproxen sodium is driven by its availability as both a prescription and over-the-counter (OTC) drug. The increasing prevalence of arthritis and other painful conditions, particularly among the geriatric population, has propelled the market. Additionally, the well-established profiling of its benefits and risks and the fast-track development of new pharmaceutical industries have contributed to the market's growth[4].

Financial Trajectory

The global naproxen market is expected to witness significant growth during the forecast period from 2024 to 2031. The market size is projected to increase substantially, driven by the increasing prevalence of arthritis and the growing focus on pain and swelling treatment. Historical data and forecast data indicate a substantial increase in revenue, with the market expected to reach a significant value by 2031[2][3].

Revenue Forecast

The revenue forecast for the naproxen market indicates a substantial increase, with the market expected to expand at a notable rate. The global anti-inflammatory drugs market, which includes naproxen, is expected to reach around USD 272.35 billion by 2033, expanding at a CAGR of 8.5% from 2024 to 2033[3].

Challenges and Restraints

Despite the growth potential, the naproxen sodium market faces several challenges. These include cardiovascular risks, such as myocardial infarctions and strokes, particularly in older populations, and gastrointestinal risks, such as upper gastrointestinal bleeding. Competition from other drugs with lower risks of abdominal ulcers or allergic reactions also hampers the growth of the naproxen market[1][4].

Cardiovascular Risks

Naproxen sodium, although having a lower cardiovascular risk compared to other NSAIDs, still poses significant risks, especially in older populations. This must be considered when prescribing the drug[5].

Gastrointestinal Risks

The drug is associated with higher rates of upper gastrointestinal bleeding compared to other NSAIDs, which is a significant restraint in the market[5].

Competition from Other Drugs

The availability of other drugs with lower risks of abdominal ulcers or allergic reactions competes with naproxen sodium. This competition includes steroids and other NSAIDs, which can hamper the growth of the naproxen market[1].

Analyst Insights

Analysts predict that the price trend for naproxen sodium will oscillate in the coming quarters due to global supply chain uncertainties, geopolitical shifts, and economic factors. The ongoing global supply chain uncertainties coupled with potential geopolitical and economic shifts will likely impact the pharmaceutical and allied markets[1][2].

"According to Procurement Resource, the Naproxen Sodium market is poised for continued volatility. The ongoing global supply chain uncertainties coupled with potential geopolitical and economic shifts will likely impact the pharmaceutical and allied markets."[1]

Market Segmentation

The naproxen market is segmented based on disease indication, formulation, and distribution channel. Key disease indications include osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and menstrual cramps. Formulations include oral tablets and liquid suspension, while distribution channels include hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms[4].

Key Takeaways

• Market Drivers: Availability as OTC, increasing prevalence of arthritis, and diverse applications.
• Market Segmentation: By formulation, disease indication, and distribution channel.
• Geographical Market: North America, Europe, and Asia-Pacific show varying trends due to supply chain and economic factors.
• Financial Trajectory: Expected growth with oscillating price trends due to global uncertainties.
• Challenges: Cardiovascular and gastrointestinal risks, competition from other drugs.

FAQs

What are the primary uses of naproxen sodium?

Naproxen sodium is primarily used for managing pain, menstrual cramps, and inflammatory conditions such as osteoarthritis and rheumatoid arthritis.

Why is naproxen sodium available as both a prescription and OTC drug?

Naproxen sodium is available as both a prescription and OTC drug due to its well-established profiling of benefits and risks, allowing it to be safely used in various medical conditions.

What are the major drivers of the naproxen market?

The major drivers include its availability as a non-prescription drug, increasing prevalence of arthritis, and fast-track development of new pharmaceutical industries.

What are the key challenges facing the naproxen market?

Key challenges include cardiovascular risks, gastrointestinal risks, and competition from other drugs with lower risks of abdominal ulcers or allergic reactions.

How is the global anti-inflammatory drugs market expected to grow?

The global anti-inflammatory drugs market is expected to reach around USD 272.35 billion by 2033, expanding at a CAGR of 8.5% from 2024 to 2033.

Cited Sources

1. Procurement Resource - Naproxen Sodium Price Trend and Forecast
2. DrugPatentWatch - Generic NAPROXEN SODIUM INN entry, pharmaceutical patent
3. Biospace - Anti-inflammatory Drugs Market Size to Hit USD 272.35 Bn by 2033
4. Transparency Market Research - Naproxen Market Insight and Trends 2024
5. Marketscreener - Roche: ambitions set out at Pharma Day 2024