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Last Updated: December 22, 2024

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for naproxen sodium; pseudoephedrine hydrochloride and what is the scope of patent protection?

Naproxen sodium; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Bayer, Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

See all NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076518-001 Mar 17, 2004 OTC No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer ALEVE-D SINUS & COLD naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021076-001 Nov 29, 1999 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Inc NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077381-001 Sep 27, 2006 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211360-001 Jun 1, 2022 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naproxen Sodium and Pseudoephedrine Hydrochloride

Introduction

Naproxen sodium and pseudoephedrine hydrochloride are commonly used in combination to treat various symptoms associated with colds, sinus infections, and flu. This article delves into the market dynamics and financial trajectory of these medications, highlighting their usage, market size, growth prospects, and challenges.

Market Size and Growth

The global market for naproxen sodium is expected to witness significant growth from 2024 to 2031. This growth is driven by the increasing prevalence of arthritis and the rising demand for pain and swelling treatment. The market size is projected to increase substantially, fueled by the growing need for effective pain relief and anti-inflammatory medications[3].

Revenue Forecast

The revenue forecast for naproxen sodium indicates a substantial increase over the forecast period. Historical data from 2021-2022 and forecast data from 2024-2031 provide a comprehensive view of the market's financial trajectory. The market is expected to reach a significant value by 2031, reflecting the strong demand for these medications[3].

Product Formulations and Usage

Naproxen sodium and pseudoephedrine hydrochloride are often combined in extended-release formulations to provide 12-hour multi-symptom relief for sinus pressure, headache, sinus congestion, nasal congestion, and body aches. Products like All Day Sinus & Cold D, which contains 220 mg of naproxen sodium and 120 mg of pseudoephedrine hydrochloride, are popular due to their non-drowsy and extended-release properties[2][5].

Market Drivers

Several factors drive the market for these medications:

  • Increasing Prevalence of Arthritis: The growing number of patients with arthritis contributes significantly to the demand for naproxen sodium, an effective nonsteroidal anti-inflammatory drug (NSAID)[3].
  • Seasonal Demand: Cold, sinus, and flu seasons create periodic spikes in demand for combination products containing naproxen sodium and pseudoephedrine hydrochloride[2][5].
  • Convenience and Efficacy: Extended-release formulations offer patients the convenience of fewer doses and sustained relief, enhancing patient compliance and satisfaction.

Challenges and Restraints

Despite the growth prospects, there are several challenges and restraints affecting the market:

  • Cardiovascular Risks: Both naproxen sodium and pseudoephedrine hydrochloride have cardiovascular risks associated with their use. Naproxen sodium can increase the risk of heart attack and stroke, while pseudoephedrine can increase blood pressure and heart rate[4][5].
  • Gastrointestinal Risks: Naproxen sodium, as an NSAID, carries gastrointestinal risks such as stomach ulcers and bleeding. This necessitates careful patient selection and monitoring[4][5].
  • Global Market Uncertainties: Supply chain disruptions, particularly from the Asia-Pacific region, have affected the prices of naproxen sodium, leading to higher production costs and tighter margins for distributors[3].

Disease Interactions

The combination of naproxen sodium and pseudoephedrine hydrochloride interacts with various diseases, which can impact their use:

  • Asthma: Patients with asthma should use these medications cautiously due to potential allergic reactions and respiratory complications[4].
  • Cardiovascular Disease: Patients with cardiovascular disease, hypertension, or heart failure need to be carefully monitored due to the potential for increased blood pressure and heart rate[4].
  • Diabetes: The use of pseudoephedrine can be contraindicated in patients with diabetes due to its potential effects on blood sugar levels[1][4].

Regulatory Considerations

Regulatory guidelines play a crucial role in the market dynamics of these medications:

  • Pregnancy and Breastfeeding: Naproxen sodium should not be used at 20 weeks or later in pregnancy unless directed by a doctor due to potential risks to the unborn child or complications during delivery. Similarly, breastfeeding women should consult a healthcare professional before using these medications[5].
  • Labeling and Warnings: Products containing naproxen sodium and pseudoephedrine hydrochloride must include clear warnings about potential allergic reactions, cardiovascular risks, and other side effects[5].

Financial Impact of Supply Chain Disruptions

Supply chain disruptions, especially from the Asia-Pacific region, have significantly impacted the prices of naproxen sodium. As of Q1 2024, the price in the U.S. was around $35,550 USD/MT, reflecting higher production costs and tighter margins for distributors[3].

Competitive Landscape

The market for naproxen sodium and pseudoephedrine hydrochloride is competitive, with several brands offering similar formulations. Brands like Aleve-D and All Day Sinus & Cold D are prominent players, competing on the basis of efficacy, convenience, and brand recognition[2][5].

Consumer Preferences

Consumer preferences also influence the market dynamics:

  • Non-Drowsy Formulations: The demand for non-drowsy formulations is high, as they offer patients the ability to manage their symptoms without the sedative effects associated with some other cold and sinus medications[2][5].
  • Extended-Release Options: Extended-release formulations are preferred due to their convenience and sustained relief, reducing the need for frequent dosing[2][5].

Key Takeaways

  • The global market for naproxen sodium and pseudoephedrine hydrochloride is expected to grow significantly from 2024 to 2031.
  • The market is driven by the increasing prevalence of arthritis and the demand for effective pain relief and anti-inflammatory medications.
  • Challenges include cardiovascular and gastrointestinal risks, as well as global market uncertainties affecting supply chains.
  • Regulatory considerations and consumer preferences play crucial roles in shaping the market dynamics.

FAQs

What are the common uses of naproxen sodium and pseudoephedrine hydrochloride?

Naproxen sodium and pseudoephedrine hydrochloride are commonly used to treat cold, sinus, and flu symptoms, including sinus pressure, headache, sinus congestion, nasal congestion, and body aches.

What are the potential cardiovascular risks associated with these medications?

Both medications can increase blood pressure and heart rate, with naproxen sodium also increasing the risk of heart attack and stroke, especially in patients with pre-existing cardiovascular conditions[4][5].

Can these medications be used during pregnancy?

Naproxen sodium should not be used at 20 weeks or later in pregnancy unless directed by a doctor due to potential risks to the unborn child or complications during delivery[5].

What are the common side effects of pseudoephedrine?

Common side effects include insomnia, headache, and hypertension. Prolonged use can lead to tachyphylaxis, reducing the medication's effectiveness[1].

How do supply chain disruptions affect the market for these medications?

Supply chain disruptions, particularly from the Asia-Pacific region, have led to higher production costs and tighter margins for distributors, affecting the prices of naproxen sodium[3].

Sources

  1. Wikipedia: Pseudoephedrine.
  2. DailyMed: DAY SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release.
  3. Drug Patent Watch: Generic NAPROXEN SODIUM INN entry, pharmaceutical patent.
  4. Drugs.com: Naproxen/pseudoephedrine and Alcohol/Food Interactions.
  5. FDA: Aleve-D Sinus & Cold and Aleve-D Sinus & Headache.

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