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Last Updated: December 22, 2024

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE Drug Patent Profile


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When do Naphazoline Hydrochloride And Pheniramine Maleate patents expire, and what generic alternatives are available?

Naphazoline Hydrochloride And Pheniramine Maleate is a drug marketed by Altaire Pharms Inc and Rising and is included in two NDAs.

The generic ingredient in NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE is naphazoline hydrochloride; pheniramine maleate. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naphazoline hydrochloride; pheniramine maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Naphazoline Hydrochloride And Pheniramine Maleate

A generic version of NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE was approved as naphazoline hydrochloride; pheniramine maleate by ALTAIRE PHARMS INC on September 27th, 2010.

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US Patents and Regulatory Information for NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Altaire Pharms Inc NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 078208-001 Sep 27, 2010 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE naphazoline hydrochloride; pheniramine maleate SOLUTION/DROPS;OPHTHALMIC 202795-001 Jan 24, 2013 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

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naphazoline Hydrochloride and Pheniramine Maleate

Introduction

Naphazoline hydrochloride and pheniramine maleate are active ingredients commonly found in ophthalmic solutions, used to relieve eye redness, itching, and puffiness associated with allergic conjunctivitis. This article delves into the market dynamics and financial trajectory of these drugs, highlighting key factors driving their growth and the competitive landscape.

Market Growth and Forecast

The global market for naphazoline hydrochloride, chlorphenamine maleate, and vitamin B12 eye drops has experienced significant growth in recent years. This trend is expected to continue, with the market forecast to register rapid growth from 2021 to 2028. The increasing prevalence of chronic diseases, advancements in the healthcare and medical sectors, and high adoption of the latest tools and techniques are key drivers of this growth[1].

Driving Factors

Several factors contribute to the robust growth of this market:

Increasing Prevalence of Chronic Diseases

The rise in chronic diseases, particularly those affecting the eyes such as allergic conjunctivitis, has led to an increased demand for effective ophthalmic solutions. Naphazoline hydrochloride and pheniramine maleate, with their decongestant and antihistamine properties, respectively, are well-positioned to meet this demand[1].

Advancements in Healthcare

Technological innovations and improvements in healthcare facilities and systems have enhanced the delivery and efficacy of ophthalmic treatments. This includes the adoption of advanced devices and equipment in hospitals, ambulatory surgical care centers, and clinics worldwide[1].

High Adoption of Home Care Settings

The increasing preference for home care settings and point-of-care diagnostics has boosted the demand for over-the-counter (OTC) ophthalmic solutions. Naphazoline hydrochloride and pheniramine maleate eye drops, available OTC, benefit from this trend[1].

Investments in Research and Development

Significant investments in research and development activities by both public and private sectors are driving the development of new and improved ophthalmic solutions. This includes the development of more efficient analytical methods for ensuring the quality and purity of these drugs[3][5].

Competitive Landscape

The market for naphazoline hydrochloride and pheniramine maleate eye drops is highly competitive, with several key players operating at both regional and global levels. These companies include:

  • Novartis AG
  • Allergan, Inc.
  • Meda Pharmaceuticals Inc.
  • Bausch & Lomb Inc.
  • Cigna
  • Similasan Corporation
  • Visine
  • Alcon
  • Viva Opti-Free
  • Rite Aid

These companies employ various strategies such as R&D investments, license agreements, partnerships, mergers and acquisitions, collaborations, and joint ventures to maintain their market position[1].

Regulatory Approval and Compliance

The approval process for naphazoline hydrochloride and pheniramine maleate ophthalmic solutions is stringent. For instance, the FDA has approved several ANDAs (Abbreviated New Drug Applications) for these products, ensuring they are bioequivalent to reference listed drugs and meet all safety and efficacy standards[2][4].

Analytical Methods for Quality Assurance

To ensure compliance with regulatory requirements, advanced analytical methods are developed for the simultaneous determination of naphazoline hydrochloride and pheniramine maleate, along with their related compounds. High-performance liquid chromatography (HPLC) methods, such as those using the XSelect™ CSH C18 Column, are widely used for this purpose. These methods ensure the purity and accuracy of the drug formulations, meeting USP monographs’ criteria[3][5].

Market Segmentation

The market for naphazoline hydrochloride and pheniramine maleate eye drops is segmented based on type, application, and region:

Type Outlook

  • Eyestrain
  • Conjunctival Hyperemia
  • Other

Application Outlook

  • Adult
  • Children

Regional Outlook

The market is analyzed across various regions, with each region showing different growth patterns based on local healthcare needs and regulatory environments[1].

Impact of the Pandemic

The ongoing pandemic has significantly altered the dynamics of the pharma and healthcare sector. Challenges such as medicine shortages and increased demand for healthcare devices have opened lucrative growth opportunities for market players. This has accelerated the adoption of home care settings and point-of-care diagnostics, further boosting the demand for OTC ophthalmic solutions like naphazoline hydrochloride and pheniramine maleate[1].

Financial Trajectory

The financial trajectory of the market is promising, driven by the increasing demand for effective ophthalmic treatments. Here are some key financial indicators:

  • Revenue Growth: The global market is expected to register rapid revenue growth over the forecast period, driven by factors such as increasing healthcare spending and improving healthcare facilities[1].
  • Investments: Significant investments in R&D and the growing funds from public and private sectors are expected to drive market revenue growth[1].
"The global Naphazoline Hydrochloride, Chlorphenamine Maleate & Vitamin B12 Eye Drops market has significantly grown over the recent past and is expected to register rapid growth over the forecast period of 2021 to 2028."[1]

Key Takeaways

  • The market for naphazoline hydrochloride and pheniramine maleate eye drops is driven by increasing chronic diseases, healthcare advancements, and high adoption of home care settings.
  • Key players are adopting various strategies to maintain their market position.
  • Advanced analytical methods ensure the quality and purity of these drugs.
  • The pandemic has accelerated the demand for OTC ophthalmic solutions.
  • The market is expected to show rapid revenue growth over the forecast period.

FAQs

What are the primary uses of naphazoline hydrochloride and pheniramine maleate eye drops?

Naphazoline hydrochloride and pheniramine maleate eye drops are used to relieve eye redness, itching, and puffiness associated with allergic conjunctivitis, hay fever, and other allergic conditions.

Which companies are key players in this market?

Key players include Novartis AG, Allergan, Inc., Meda Pharmaceuticals Inc., Bausch & Lomb Inc., Cigna, Similasan Corporation, Visine, Alcon, Viva Opti-Free, and Rite Aid.

What are the driving factors for the growth of this market?

The market growth is driven by the increasing prevalence of chronic diseases, advancements in healthcare, high adoption of home care settings, and significant investments in R&D.

How do regulatory bodies ensure the quality of these drugs?

Regulatory bodies like the FDA ensure the quality by approving ANDAs that demonstrate the drugs are bioequivalent to reference listed drugs and meet all safety and efficacy standards.

What is the expected financial trajectory of this market?

The market is expected to register rapid revenue growth over the forecast period, driven by increasing healthcare spending and improving healthcare facilities.

Sources

  1. Reports and Data, "Global Naphazoline Hydrochloride, Chlorphenamine Maleate & Vitamin B12 Eye Drops Market – Forecast to 2028," Biospace, July 8, 2022.
  2. FDA, "Naphazoline Hydrochloride 0.027% and Pheniramine Maleate 0.315% Ophthalmic Solution USP," Accessdata.fda.gov, September 27, 2010.
  3. Waters, "Simultaneous Determination of Naphazoline Hydrochloride and Pheniramine Maleate Along With Their Related Compounds by High-Performance Liquid Chromatography," Waters.com, 2023.
  4. FDA, "Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3% Ophthalmic Solution, USP," Accessdata.fda.gov, January 24, 2013.
  5. Waters, "Efficient Method Development for the Analysis of Naphazoline Hydrochloride, Pheniramine Maleate, and Associated Related Substances Using a Systematic Screening Protocol," Waters.com, 2023.

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