Naproxen - Generic Drug Details

What are the generic sources for naproxen and what is the scope of patent protection?

Naproxen is the generic ingredient in twelve branded drugs marketed by Atnahs Pharma Us, Amneal, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Trupharma, Adaptis, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Molecules, Dava Pharms Inc, Glenmark Pharms Ltd, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Norvium Bioscience, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, Actavis Labs Fl Inc, Bayer, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Marksans Pharma, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Rising, Sun Pharm, and Currax, and is included in ninety NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for naproxen. Fifty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for naproxen

US Patents:	6
Tradenames:	12
Applicants:	58
NDAs:	90
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	57
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	323
Patent Applications:	3,391
Drug Prices:	Drug price trends for naproxen
Drug Sales Revenues:	Drug sales revenues for naproxen
What excipients (inactive ingredients) are in naproxen?	naproxen excipients list
DailyMed Link:	naproxen at DailyMed

See drug prices for naproxen

See drug sales revenues for naproxen

Recent Clinical Trials for naproxen

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

Sponsor	Phase
Mclean Hospital	Phase 4
United States Department of Defense	Phase 4
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 1

See all naproxen clinical trials

Generic filers with tentative approvals for NAPROXEN

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET;ORAL
		375MG	TABLET;ORAL
		250MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for naproxen

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

Medical Subject Heading (MeSH) Categories for naproxen

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Gout Suppressants

Anatomical Therapeutic Chemical (ATC) Classes for naproxen

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for naproxen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	205497-001	Mar 18, 2016		OTC	No	No
Watson Labs	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074455-002	May 31, 1995		DISCN	No	No
Novitium Pharma	NAPROXEN	naproxen	TABLET, DELAYED RELEASE;ORAL	218497-002	Jun 12, 2024	AB	RX	No	No
Hikma	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074480-002	Feb 18, 1998		DISCN	No	No
Watson Labs	NAPROXEN	naproxen	TABLET;ORAL	074457-002	May 31, 1995		DISCN	No	No
Purepac Pharm	NAPROXEN	naproxen	TABLET;ORAL	074263-003	Dec 21, 1993		DISCN	No	No
Norvium Bioscience	NAPROXEN	naproxen	TABLET;ORAL	074121-003	Dec 21, 1993		DISCN	No	No

Expired US Patents for naproxen

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
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-004	Apr 15, 1982
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-004	Apr 15, 1982
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982

Naproxen Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Naproxen

Introduction to Naproxen

Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), is widely used to relieve pain, reduce inflammation, and lower fever. It is employed in treating various conditions, including arthritis, muscle aches, tendonitis, and menstrual cramps[4].

Market Drivers

The naproxen market is driven by several key factors:

Increasing Prevalence of Arthritis and Chronic Pain

The rising prevalence of arthritis and other chronic pain conditions is a significant driver. As the global population ages, the incidence of conditions like osteoarthritis, rheumatoid arthritis, and back pain increases, leading to higher demand for naproxen[1][2][4].

Availability as a Non-Prescription Drug

Naproxen's availability over-the-counter (OTC) enhances its market appeal. Consumers prefer OTC medications for their convenience and accessibility, contributing to the growth of the naproxen market[1][2].

Growing Pharmaceutical Industry

The expansion of the pharmaceutical industry, particularly in developing nations, creates new opportunities for naproxen. This growth is fueled by increasing healthcare spending and a greater focus on treating pain and inflammation[4].

Market Segmentation

The naproxen market is segmented based on several criteria:

Formulation

The market is segmented into oral tablets and liquid suspensions. These formulations cater to different patient needs and preferences, ensuring a broad market reach[4].

Indication

Naproxen is used for various indications, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile arthritis, bursitis, menstrual cramps, gout, and tendonitis. This diverse range of applications strengthens its market position[4].

Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms. The inclusion of online sales has significantly expanded the market's reach and convenience[4].

Regional Framework

The naproxen market is analyzed across several regions:

North America

North America is a significant market due to the high prevalence of chronic pain conditions and a well-established pharmaceutical industry. The region experiences steady demand driven by consumer preference for OTC medications[2][5].

Europe

Europe, particularly Germany, shows robust demand for naproxen. Seasonal variations and economic factors influence the pricing and availability of naproxen sodium in this region[5].

Asia-Pacific

In Asia-Pacific, the market has seen fluctuations due to factors such as subdued demand from downstream industries, surplus inventories, and reduced production expenses. However, the region remains a crucial part of the global naproxen market[5].

Challenges and Restraints

Despite the growth drivers, the naproxen market faces several challenges:

Side Effects and Health Risks

Naproxen is associated with potential side effects such as cardiovascular events, abdominal bleeding or ulcers, and allergic reactions, particularly in older populations. These risks act as restraints on the market[1].

Economic and Supply Chain Challenges

The market is impacted by economic challenges, including inflationary pressures, labor shortages, and rising freight costs. These factors complicate the supply chain and increase operational costs for pharmaceutical companies[2].

Price Volatility

The price of naproxen sodium is subject to volatility due to supply chain disruptions, currency fluctuations, and changes in demand from downstream industries. This volatility can affect the profitability of pharmaceutical companies[5].

Financial Trajectory

The financial trajectory of the naproxen market is promising but complex:

Market Size and Growth Rate

The global naproxen market is expected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2031. The market size is projected to increase substantially, driven by the factors mentioned above[3][4].

Revenue Forecast

Revenue forecasts indicate a steady increase, driven by the growing demand for naproxen in various regions. However, the market must navigate through economic and supply chain challenges to maintain this growth trajectory[4].

Cost and Pricing Trends

The cost of naproxen sodium is influenced by production costs, supply chain disruptions, and economic factors. The prices have shown an upward trend in North America and Europe but have been more volatile in Asia-Pacific[5].

Industry and Competitive Landscape

The naproxen market is competitive, with several key players:

Key Players

Companies such as those involved in the production and distribution of naproxen are focusing on organic and inorganic growth strategies. These include product launches, approvals, acquisitions, and partnerships to expand their market share[4].

SWOT Analysis

A SWOT analysis of the market reveals strengths in the growing demand and well-established benefits of naproxen, weaknesses in the potential side effects, opportunities in the expanding pharmaceutical industry, and threats from economic and supply chain challenges[4].

Analyst Insights

Industry analysts highlight the need for pharmaceutical companies to remain vigilant and adaptive to the evolving market environment. Here is a key insight:

"The surge in Naproxen API demand reflects broader trends in the healthcare sector, driven by demographic and therapeutic factors. However, the persistent economic challenges posed by inflation and supply chain disruptions may cast a shadow on the pharmaceutical industry's growth prospects as it navigates through the complexities of the current market environment."[2]

Key Takeaways

• The naproxen market is driven by the increasing prevalence of arthritis and chronic pain conditions.
• The availability of naproxen as an OTC drug and its well-established benefits and risks profile are significant market drivers.
• Economic and supply chain challenges, including inflation and labor shortages, pose restraints on the market.
• The market is expected to grow at a significant CAGR from 2024 to 2031.
• Key players are focusing on both organic and inorganic growth strategies to expand their market share.

Frequently Asked Questions

Q: What are the primary drivers of the naproxen market? A: The primary drivers include the increasing prevalence of arthritis and chronic pain conditions, the availability of naproxen as an OTC drug, and the growing pharmaceutical industry in developing nations.

Q: What are the potential side effects of naproxen? A: Naproxen can cause cardiovascular events, abdominal bleeding or ulcers, and allergic reactions, particularly in older populations.

Q: How does the economic environment impact the naproxen market? A: Economic challenges such as inflation, labor shortages, and rising freight costs can increase operational costs and complicate the supply chain, affecting the profitability of pharmaceutical companies.

Q: What regions are significant for the naproxen market? A: North America, Europe, and Asia-Pacific are significant regions, each with unique market dynamics influenced by local demand, economic factors, and supply chain conditions.

Q: What strategies are key players adopting to grow in the naproxen market? A: Key players are adopting both organic and inorganic growth strategies, including product launches, approvals, acquisitions, and partnerships to expand their market share.

Sources:

1. Transparency Market Research. Naproxen Market Insight and Trends 2024.
2. ChemAnalyst. Continuous Surge in Naproxen API Demand in the USA Amid Economic Challenges.
3. Cognitivemarketresearch. Naproxen Market Report 2024 (Global Edition).
4. The Insight Partners. Naproxen Market SWOT Analysis by 2031.
5. Procurement Resource. Naproxen Sodium Price Trend, Index, News, Chart, Forecast.