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Last Updated: December 22, 2024

CYCLOPENTOLATE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for cyclopentolate hydrochloride and what is the scope of freedom to operate?

Cyclopentolate hydrochloride is the generic ingredient in six branded drugs marketed by Epic Pharma Llc, Rising, Alcon Labs Inc, Alcon Pharms Ltd, Sciegen Pharms Inc, Sola Barnes Hind, Bausch And Lomb, and Pharmafair, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cyclopentolate hydrochloride. Three suppliers are listed for this compound.

Summary for CYCLOPENTOLATE HYDROCHLORIDE
US Patents:0
Tradenames:6
Applicants:8
NDAs:14
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 84
Clinical Trials: 11
Patent Applications: 1,641
What excipients (inactive ingredients) are in CYCLOPENTOLATE HYDROCHLORIDE?CYCLOPENTOLATE HYDROCHLORIDE excipients list
DailyMed Link:CYCLOPENTOLATE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CYCLOPENTOLATE HYDROCHLORIDE

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

SponsorPhase
Jordan University of Science and TechnologyPhase 4
Yarmouk UniversityPhase 4
Islamic Hospital, JordanPhase 4

See all CYCLOPENTOLATE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for CYCLOPENTOLATE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CYCLOPENTOLATE HYDROCHLORIDE

US Patents and Regulatory Information for CYCLOPENTOLATE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Labs Inc CYCLOMYDRIL cyclopentolate hydrochloride; phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 084300-001 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084109-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmafair PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 088150-001 Feb 25, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084110-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc AK-PENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 085555-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon Pharms Ltd CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 089162-001 Jan 24, 1991 DISCN 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

CYCLOPENTOLATE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Cyclopentolate Hydrochloride Eye Drops Market: Dynamics and Financial Trajectory

Market Overview

The cyclopentolate hydrochloride eye drops market has been experiencing significant growth in recent years, driven by several key factors. This market is crucial for ophthalmic examinations, as these eye drops facilitate thorough retina and corneal assessments by dilating pupils.

Growth Drivers

Increasing Prevalence of Eye Conditions

The rising prevalence of eye conditions, such as cataracts, glaucoma, and age-related macular degeneration, is a major driver of the market. As the global population ages, the demand for diagnostic tools like cyclopentolate hydrochloride eye drops increases[4].

Expanding Diagnostic Practices

Advancements in ophthalmic treatments and the increase in routine eye screenings have boosted the demand for these eye drops. Thorough retina and corneal assessments are essential for accurate diagnoses, making cyclopentolate hydrochloride a vital component in ophthalmic care[4].

Technological Advancements

Technological advancements in drug formulations and delivery systems have improved the efficacy and patient compliance of cyclopentolate hydrochloride eye drops. These innovations have contributed to the market's growth by enhancing the overall user experience and treatment outcomes[4].

Growing Awareness of Eye Health

Increased awareness about eye health and preventive care has also driven the market. Public health campaigns and educational initiatives have raised awareness about the importance of regular eye examinations, further fueling the demand for cyclopentolate hydrochloride eye drops[4].

Market Segmentation

By Type

The market is segmented based on the type of cyclopentolate hydrochloride eye drops, primarily into 5ml/vial and 15ml/vial categories. Each type serves different needs and is used in various ophthalmic procedures[1].

By Application

The applications of cyclopentolate hydrochloride eye drops include dilated pupils, ciliary muscle paralysis, and other ophthalmic procedures such as cycloplegia and mydriasis induction. These applications are critical in both diagnostic and therapeutic ophthalmology[1][2].

By Geography

Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics, influenced by local healthcare infrastructure, regulatory environments, and consumer preferences[1][4].

Financial Trajectory

Current Market Size

As of 2024, the cyclopentolate hydrochloride eye drops market is valued at approximately USD 8.1 billion. This valuation reflects the growing demand for these eye drops across various regions and applications[4].

Future Growth Prospects

The market is anticipated to witness a compound annual growth rate (CAGR) of 12.21% from 2024 to 2031. By the end of 2031, the market is expected to reach a valuation of USD 18.13 billion. This significant growth is driven by the factors mentioned above, including increasing prevalence of eye conditions, expanding diagnostic practices, and technological advancements[4].

Competitive Scenario

Key Players

The market is dominated by several key players, including Bausch and Lomb, Alcon, Akorn Pharma, Bal Pharma, Indiana Ophthalmics, Odan Labo, and Pharmascience. These companies are involved in the development, manufacturing, and distribution of cyclopentolate hydrochloride eye drops, and they play a crucial role in shaping the market's competitive landscape[1][4].

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[4].

Regional Analysis

North America

North America is a significant market for cyclopentolate hydrochloride eye drops, driven by a well-established healthcare infrastructure and high consumer awareness about eye health. The region is characterized by a mature market with strong demand for diagnostic and therapeutic ophthalmic products[4].

Europe

Europe is another major region, comprising countries such as the United Kingdom, Germany, France, and Italy. The European market is mature with well-established infrastructure and consumer preferences, contributing to the overall growth of the cyclopentolate hydrochloride eye drops market[4].

Asia-Pacific

The Asia-Pacific region is rapidly growing, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region are key factors driving the demand for cyclopentolate hydrochloride eye drops[4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa represent emerging markets with potential for growth. Countries like Brazil, Mexico, Argentina, UAE, Saudi Arabia, South Africa, and Nigeria are showing promising growth potential due to economic diversification efforts, urbanization, and a young population[4].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the cyclopentolate hydrochloride eye drops market. For instance, the nomination of cyclopentolate hydrochloride for inclusion on the 503B Bulks List by various organizations highlights the regulatory scrutiny and approval processes that these products must undergo[2].

Sustainability and Eco-Friendliness

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives. This trend is expected to boost the demand for eco-friendly cyclopentolate hydrochloride eye drops products and services, presenting an opportunity for companies to innovate and capture a larger market share[4].

Key Takeaways

  • The cyclopentolate hydrochloride eye drops market is expected to grow significantly, driven by increasing prevalence of eye conditions, expanding diagnostic practices, and technological advancements.
  • The market is anticipated to reach a valuation of USD 18.13 billion by 2031, with a CAGR of 12.21% from 2024 to 2031.
  • Key players are engaging in mergers and acquisitions to consolidate market positions and leverage synergies.
  • Regional markets, especially in Asia-Pacific and Latin America, are showing promising growth potential.

FAQs

What is the current market size of the cyclopentolate hydrochloride eye drops market?

The cyclopentolate hydrochloride eye drops market is currently valued at approximately USD 8.1 billion as of 2024[4].

What is the expected growth rate of the cyclopentolate hydrochloride eye drops market from 2024 to 2031?

The market is anticipated to witness a compound annual growth rate (CAGR) of 12.21% from 2024 to 2031[4].

What are the primary applications of cyclopentolate hydrochloride eye drops?

The primary applications include dilated pupils, ciliary muscle paralysis, cycloplegia, and mydriasis induction[1][2].

Which regions are driving the growth of the cyclopentolate hydrochloride eye drops market?

North America, Europe, and the Asia-Pacific region are significant drivers of the market, with emerging markets in Latin America and the Middle East & Africa also showing growth potential[4].

What are the key factors driving the demand for cyclopentolate hydrochloride eye drops?

Key factors include the increasing prevalence of eye conditions, expanding diagnostic practices, technological advancements, and growing awareness about eye health[4].

Sources

  1. Market Research Intellect: Global Cyclopentolate Hydrochloride Eye Drops Market Size, Scope ...
  2. University of Maryland, Baltimore: Cyclopentolate Hydrochloride - Summary Report
  3. Market Research Intellect: Global Cyclopentolate Market Size, Scope And Forecast Report
  4. OpenPR: Cyclopentolate Hydrochloride Eye Drops Market Size, Share

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