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Last Updated: December 22, 2024

PARACAINE Drug Patent Profile


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

Paracaine is a drug marketed by Optopics and is included in one NDA.

The generic ingredient in PARACAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Paracaine

A generic version of PARACAINE was approved as proparacaine hydrochloride by BAUSCH AND LOMB on September 29th, 1995.

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Summary for PARACAINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 47
Patent Applications: 4,053
DailyMed Link:PARACAINE at DailyMed
Drug patent expirations by year for PARACAINE

US Patents and Regulatory Information for PARACAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Optopics PARACAINE proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 087681-001 Aug 5, 1982 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

PARACAINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ophthalmic Anesthetic Drugs: Focus on Proparacaine (Proparacaine)

Introduction to Ophthalmic Anesthetic Drugs

Ophthalmic anesthetic drugs, including proparacaine, are crucial in the management of ocular procedures, providing pain relief and facilitating various eye surgeries and examinations.

Market Size and Growth

The global ophthalmic anesthetic drugs market is projected to grow significantly over the forecast period of 2023 to 2030. The market size was valued at USD 125.25 billion in 2022 and is expected to reach USD 160.65 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 3.16% during this period[1].

Drivers of Market Growth

Increasing Prevalence of Ocular Disorders

The rising incidence of ocular disorders such as diabetic retinopathy, presbyopia, and macular degeneration is a key driver of the market. For instance, the number of people with Age-related Macular Degeneration (AMD) in the U.S. is anticipated to increase from 2.07 million in 2030 to 5.44 million in 2050[1].

Growing Elderly Population

The increasing geriatric population is another significant factor. As per the World Health Organization (WHO), the global geriatric population is expected to rise from over 524 million in 2010 to approximately 2 billion by 2050. This demographic shift increases the demand for ophthalmic anesthetic drugs due to the higher susceptibility of elderly individuals to eye diseases[1].

Segmentation of the Market

By Type

The market is segmented into local, general, topical, facial block, retrobulbar block, and peribulbar block anesthetics. Proparacaine, a topical anesthetic, is widely used for minor eye procedures and examinations.

By Drugs

Key drugs in the market include proparacaine 0.5%, tetracaine hydrochloride, and others. Proparacaine is particularly popular due to its efficacy and safety profile.

By End-Users

The market is segmented into hospitals, specialty clinics, homecare, and others. Hospitals and specialty clinics are the primary end-users of ophthalmic anesthetic drugs.

By Distribution Channel

The distribution channels include hospital pharmacy, retail pharmacy, online pharmacy, and others. Hospital pharmacies are the dominant distribution channel for these drugs[1].

Financial Trajectory of Key Players

Revenue and Sales

Companies like Pacira BioSciences, although not exclusively focused on ophthalmic anesthetics, provide insights into the financial dynamics of the broader anesthetic market. For example, Pacira BioSciences reported total revenues of $167.1 million in the first quarter of 2024, with net product sales of $132.4 million for EXPAREL, a non-opioid pain management product. This indicates a strong financial performance in the anesthetic drug market, which can be extrapolated to the ophthalmic segment[2].

Research and Development

Significant investments in research and development (R&D) are crucial for the growth of ophthalmic anesthetic drugs. For instance, Pacira BioSciences spent $18.2 million on R&D in the first quarter of 2024, which includes costs for product development and manufacturing capacity expansion[2].

Market Acquisitions and Mergers

The growing rate of acquisitions and mergers is a trend in the anesthetics market. This strategy helps companies save time and costs associated with R&D and intellectual property (I.P.) investments, thereby driving market growth[1].

Regional Market Dynamics

North America

North America dominates the ophthalmic anesthetic drugs market due to the high number of research and development activities, surging healthcare expenditure, and the presence of major market players[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to its well-established veterinary healthcare infrastructure and large population, which increases the demand for ophthalmic anesthetic drugs[1].

Healthcare Infrastructure and Technology

The growth in healthcare expenditure and the adoption of new technologies are critical factors influencing the market. For example, the installed base of different products for ophthalmic anesthetic drugs and the impact of technological advancements are key drivers of market growth[1].

Regulatory Framework

Regulatory approvals and changes in healthcare policies significantly impact the market. For instance, the FDA approval of combination products like Altafluor Benox (containing fluorescein sodium and benoxinate hydrochloride) highlights the regulatory environment's influence on market dynamics[4].

Cost and Pricing Analysis

The cost of prescription medicines, including ophthalmic anesthetics, is influenced by various factors such as rebates, discounts, and negotiations with pharmacy benefit managers (PBMs). The net prices for brand medicines have decreased due to these negotiations, which can affect the financial trajectory of ophthalmic anesthetic drugs[3].

Key Takeaways

  • The global ophthalmic anesthetic drugs market is expected to grow from USD 125.25 billion in 2022 to USD 160.65 billion by 2030.
  • Increasing prevalence of ocular disorders and the growing elderly population are key drivers of market growth.
  • Proparacaine, as a topical anesthetic, plays a significant role in the market.
  • North America and Asia-Pacific are critical regions driving market growth.
  • Regulatory approvals and technological advancements are crucial for market dynamics.

FAQs

1. What is the projected market size of the global ophthalmic anesthetic drugs market by 2030?

The global ophthalmic anesthetic drugs market is expected to reach USD 160.65 billion by 2030[1].

2. What are the primary drivers of the ophthalmic anesthetic drugs market?

The primary drivers include the increasing prevalence of ocular disorders and the growing elderly population[1].

3. Which region dominates the ophthalmic anesthetic drugs market?

North America currently dominates the market due to high R&D activities and healthcare expenditure[1].

4. How do regulatory approvals impact the ophthalmic anesthetic drugs market?

Regulatory approvals, such as the FDA approval of combination products, significantly influence market dynamics and growth[4].

5. What role do pharmacy benefit managers (PBMs) play in the pricing of ophthalmic anesthetic drugs?

PBMs negotiate significant discounts and rebates with manufacturers, which can affect the net prices of these drugs[3].

Cited Sources:

  1. Data Bridge Market Research - Global Ophthalmic Anesthetic Drugs Market.
  2. Pacira BioSciences - First Quarter 2024 Financial Results.
  3. PhRMA - Understanding Prescription Medicine Spending.
  4. FDA - Post-market experience data for the proposed drug product.

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