NAPROXEN SODIUM Drug Patent Profile

When do Naproxen Sodium patents expire, and what generic alternatives are available?

Naproxen Sodium is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Softgels, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma. and is included in forty-eight NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in thirteen countries.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naproxen Sodium

A generic version of NAPROXEN SODIUM was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17^th, 2004.

Summary for NAPROXEN SODIUM

International Patents:	15
US Patents:	5
Applicants:	40
NDAs:	48
Finished Product Suppliers / Packagers:	119
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	100
Patent Applications:	6,075
Drug Prices:	Drug price information for NAPROXEN SODIUM
Drug Sales Revenues:	Drug sales revenues for NAPROXEN SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAPROXEN SODIUM
What excipients (inactive ingredients) are in NAPROXEN SODIUM?	NAPROXEN SODIUM excipients list
DailyMed Link:	NAPROXEN SODIUM at DailyMed

See drug prices for NAPROXEN SODIUM

See drug sales revenues for NAPROXEN SODIUM

Recent Clinical Trials for NAPROXEN SODIUM

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

Sponsor	Phase
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 1
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 3
Ciusss de L'Est de l'Île de Montréal	N/A

See all NAPROXEN SODIUM clinical trials

Pharmacology for NAPROXEN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for NAPROXEN SODIUM

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

Paragraph IV (Patent) Challenges for NAPROXEN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAPROXEN SODIUM	Capsules	naproxen sodium	200 mg	021920	1	2017-11-15

US Patents and Regulatory Information for NAPROXEN SODIUM

NAPROXEN SODIUM is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hamilton Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074106-001	Aug 31, 1993		DISCN	No	No
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074198-001	Dec 21, 1993		DISCN	No	No
Roxane	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074257-001	Dec 21, 1993		DISCN	No	No
Purepac Pharm	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074319-002	Mar 20, 1995		DISCN	No	No
Norvium Bioscience	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074367-001	Aug 31, 1994		DISCN	No	No
Pld Acquisitions Llc	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074646-001	Jan 13, 1997		DISCN	No	No
Granules	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	213663-001	Sep 24, 2020		OTC	No	No

International Patents for NAPROXEN SODIUM

See the table below for patents covering NAPROXEN SODIUM around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2600023	SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)
China	102940887	Solvent system for enhancing the solubility of pharmaceutical agents
Denmark	1863458
European Patent Office	1863458	SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)
European Patent Office	3061447	SYSTÈME DE SOLVANT DESTINÉ À AMÉLIORER LA SOLUBILITÉ D'AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)
Portugal	1863458
Spain	2606767

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
0984957	122012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Naproxen Sodium Market Dynamics and Financial Trajectory

Market Overview

Naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), is widely used for managing pain, menstrual cramps, and inflammatory conditions. The market for naproxen sodium is driven by several key factors and faces various challenges.

Drivers of the Naproxen Sodium Market

Availability and Established Profiling

The availability of naproxen sodium as both a prescription and over-the-counter (OTC) drug is a significant driver. Its well-established profiling of benefits and risks, particularly over 18 years, has led to its approval for OTC use in many countries, including the U.S. since 1994[1].

Increasing Prevalence of Arthritis

The rising prevalence of arthritis, including osteoarthritis (OA) and rheumatoid arthritis (RA), is a major driver. As the global population ages, the incidence of these conditions increases, thereby boosting the demand for naproxen sodium[3].

Diverse Applications

Naproxen sodium is not only used for arthritis but also for muscle strain relief, back pain, knee pain, and other painful conditions. This broad range of applications contributes to its market growth[1].

Market Segmentation

By Formulation

The market is segmented into oral tablets and liquid suspension. Oral tablets, particularly the 220 mg and 275 mg formulations, are the most common[1][3].

By Disease Indication

The market is segmented based on various disease indications, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile arthritis, bursitis, menstrual cramps, gout, and tendonitis[1][3].

By Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms. The rise of e-commerce has expanded the reach of naproxen sodium[1][3].

Geographical Market

North America

In North America, particularly in the U.S., the market has seen a steady upward trajectory in prices due to supply constraints, elevated production costs, and geopolitical factors. Supply chain disruptions and natural disasters have also impacted the market[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[2].

Asia-Pacific

In Asia, 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[2].

Financial Trajectory

Price Trends

The price of naproxen sodium is expected to oscillate due to global market uncertainties. In the U.S., prices were affected by supply chain disruptions, particularly from the Asia-Pacific region, 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[2].

Market Size and Growth

The global naproxen market is expected to witness high growth during the forecast period from 2024 to 2031. The market size is projected to increase significantly, driven by the increasing prevalence of arthritis and the growing focus on pain and swelling treatment[3].

Revenue Forecast

The revenue forecast indicates a substantial increase, with the market expected to reach a significant value by 2031. Historical data from 2021-2022 and forecast data from 2024-2031 provide a comprehensive view of the market's financial trajectory[3].

Challenges and Restraints

Cardiovascular Risks

Although naproxen sodium has a lower cardiovascular risk compared to other NSAIDs, it still poses risks such as myocardial infarctions and strokes, particularly in older populations. This must be considered when prescribing the drug[5].

Gastrointestinal Risks

Naproxen sodium is associated with higher rates of upper gastrointestinal bleeding compared to other NSAIDs. This risk 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, including steroids and other NSAIDs, can hamper the growth of the naproxen market[1].

Analyst Insights

The naproxen sodium market is poised for continued volatility due to global supply chain uncertainties, geopolitical shifts, and economic factors. Analysts predict that the price trend will oscillate in the coming quarters, influenced by demand from downstream industries and escalating production costs[2].

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 over many years, leading to its approval for OTC use in several countries.

What are the major drivers of the naproxen sodium market?

The major drivers include its availability as an OTC drug, the increasing prevalence of arthritis, and its use in various painful conditions.

What are the potential risks associated with naproxen sodium?

Potential risks include cardiovascular events such as heart attacks and strokes, and gastrointestinal risks like upper gastrointestinal bleeding.

How does the geographical market vary for naproxen sodium?

The market varies significantly across North America, Europe, and Asia-Pacific due to factors such as supply chain disruptions, economic conditions, and local demand.

Cited Sources

1. Transparency Market Research - Naproxen Market Insight and Trends 2024
2. Procurement Resource - Naproxen Sodium Price Trend and Forecast
3. The Insight Partners - Naproxen Market SWOT Analysis by 2031
4. Market Research Intellect - Global Naproxen Sodium for Injection Market Size and Forecast
5. Wikipedia - Naproxen