ACULAR PRESERVATIVE FREE Drug Patent Profile

When do Acular Preservative Free patents expire, and what generic alternatives are available?

Acular Preservative Free is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in ACULAR PRESERVATIVE FREE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acular Preservative Free

A generic version of ACULAR PRESERVATIVE FREE was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for ACULAR PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	4,765
DailyMed Link:	ACULAR PRESERVATIVE FREE at DailyMed

Recent Clinical Trials for ACULAR PRESERVATIVE FREE

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

Sponsor	Phase
Fundação Altino Ventura	Phase 2/Phase 3

See all ACULAR PRESERVATIVE FREE clinical trials

US Patents and Regulatory Information for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No

Expired US Patents for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997

International Patents for ACULAR PRESERVATIVE FREE

See the table below for patents covering ACULAR PRESERVATIVE FREE around the world.

Country	Patent Number	Title	Estimated Expiration
Italy	1162842	COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE
Italy	8367315
Japan	H047324

Supplementary Protection Certificates for ACULAR PRESERVATIVE FREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730

Market Dynamics and Financial Trajectory for Preservative-Free Eye Drops: A Focus on ACULAR PRESERVATIVE FREE

Introduction

The market for preservative-free eye drops is experiencing significant growth, driven by increasing awareness of the potential side effects associated with preservatives and the rising incidence of eye-related diseases. This article will delve into the market dynamics and financial trajectory of preservative-free eye drops, with a particular focus on products like ACULAR PRESERVATIVE FREE.

Growing Demand for Preservative-Free Eye Drops

The global preservative-free eye drops market is projected to reach $1,587.66 million by 2030, growing at a CAGR of 4.3% from 2022 to 2030[1].

Increasing Awareness of Preservative Side Effects

One of the key drivers of this market is the growing awareness among consumers about the potential side effects of preservatives in eye drops. Preservatives can cause irritation, especially in patients with sensitive eyes or those using eye drops frequently.

Rising Incidence of Eye-Related Diseases

The increasing prevalence of eye-related diseases, particularly among the geriatric population, is another significant factor. Conditions such as dry eye disease, glaucoma, and retinal disorders are becoming more common, leading to a higher demand for preservative-free eye drops[1].

Market Segmentation

By Type

The preservative-free eye drops market is segmented into single-dose and multiple-dose categories. The single-dose segment held a significant market share in 2022 and is expected to register a higher CAGR during the forecast period. This is due to the convenience and reduced risk of contamination associated with single-dose packaging[1].

By Application

The market is also segmented by application, with dry eye disease leading the segment. Other applications include eye allergies/infections, glaucoma, retinal disorders, and other indications. The dry eye disease segment is expected to dominate the market due to its high prevalence and the need for frequent treatment[1].

By Distribution Channel

Distribution channels include hospital pharmacies, online pharmacies, and drug stores/retail pharmacies. Online pharmacies are gaining popularity due to their convenience and accessibility, which is expected to drive growth in this segment[1].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is anticipated to register the highest CAGR in the preservative-free eye drops market from 2022 to 2030. This growth is driven by a large population, increasing incidence of eye disorders, modernization of healthcare infrastructure, and rising awareness about preservative-free drops. Countries like China, Japan, and India are major contributors to this growth[1].

Financial Trajectory

Market Size and Growth

The preservative-free eye drops market was valued at $1,129.60 million in 2022 and is projected to reach $1,587.66 million by 2030. This growth is supported by increasing demand and advancements in healthcare infrastructure[1].

Revenue Streams

Revenue in the preservative-free eye drops market comes primarily from the sale of these products through various distribution channels. Companies are investing heavily in research and development to enhance product efficacy and safety, which is reflected in their financial reports. For instance, biopharmaceutical companies like Oculis are increasing their clinical development expenses, which indicates a strong focus on product innovation and market expansion[2].

Product Innovations

Advanced Technologies

Companies are leveraging advanced technologies to improve the efficacy and safety of preservative-free eye drops. For example, Sun Pharmaceutical Canada Inc.'s CEQUA uses nanomicellar (NCELL) technology to enhance drug delivery to ocular tissues, improving bioavailability and stability. Such innovations are crucial for market growth and customer satisfaction[4].

Regulatory Approvals

Regulatory approvals play a significant role in the financial trajectory of these products. For instance, Zhuhai Essex Bio-Pharmaceutical Company obtained approval for Beifushu Eye Drops, a preservative-free, single-dose product, in China. Such approvals not only validate the safety and efficacy of the products but also open up new markets and revenue streams[1].

Challenges and Opportunities

Product Recalls

Despite the growth, the market faces challenges such as product recalls, which can hinder market growth and impact consumer trust. Companies must ensure stringent quality control measures to mitigate this risk[1].

Increasing Healthcare Spending

The upsurge in healthcare spending is a significant opportunity for the preservative-free eye drops market. As healthcare expenditure increases, so does the budget for medications, including eye care products. This trend is expected to bolster the growth of the ophthalmic drugs sector, including preservative-free eye drops[4].

Key Takeaways

• The preservative-free eye drops market is expected to grow significantly, driven by increasing awareness of preservative side effects and rising eye-related diseases.
• The single-dose segment is expected to dominate the market due to its convenience and reduced risk of contamination.
• The Asia Pacific region is anticipated to register the highest CAGR due to its large population and increasing incidence of eye disorders.
• Product innovations and regulatory approvals are crucial for market growth.
• Increasing healthcare spending is expected to support the growth of the ophthalmic drugs sector.

FAQs

What is driving the growth of the preservative-free eye drops market?

The growth of the preservative-free eye drops market is driven by increasing awareness of potential side effects associated with preservatives and the rising incidence of eye-related diseases among the geriatric population[1].

Which region is expected to register the highest CAGR in the preservative-free eye drops market?

The Asia Pacific region is anticipated to register the highest CAGR in the preservative-free eye drops market from 2022 to 2030, driven by a large population and increasing incidence of eye disorders[1].

What are the main types of preservative-free eye drops?

The main types of preservative-free eye drops are single-dose and multiple-dose categories, with the single-dose segment expected to register a higher CAGR during the forecast period[1].

How does product innovation impact the market?

Product innovation, such as the use of advanced technologies like nanomicellar (NCELL) technology, enhances the efficacy and safety of preservative-free eye drops, contributing to market growth and customer satisfaction[4].

What challenges does the preservative-free eye drops market face?

The market faces challenges such as product recalls, which can hinder market growth and impact consumer trust. Ensuring stringent quality control measures is crucial to mitigate this risk[1].

Sources

1. The Insight Partners: "Preservative-Free Eye Drops Market Forecast to 2030 – Global Analysis – by Type, Application, Distribution Channel, and Geography"[1].
2. Oculis: "Oculis Reports Q2 2024 Financial Results and Provides Recent Updates"[2].
3. BioSpace: "Ophthalmic Drugs Market Size to Reach USD 70.07 Billion by 2033"[3].
4. Research and Markets: "Ophthalmic Drugs Global Market Report 2024"[4].
5. GlobeNewswire: "Artificial Tears Market Report 2023 - 2030 : Analysis By Technology, Manufacturers"[5].