OCUFEN Drug Patent Profile

When do Ocufen patents expire, and when can generic versions of Ocufen launch?

Ocufen is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in OCUFEN is flurbiprofen sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ocufen

A generic version of OCUFEN was approved as flurbiprofen sodium by BAUSCH AND LOMB on January 4^th, 1995.

Summary for OCUFEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	167
Patent Applications:	2,038
DailyMed Link:	OCUFEN at DailyMed

US Patents and Regulatory Information for OCUFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986		DISCN	Yes	No

Expired US Patents for OCUFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986

International Patents for OCUFEN

See the table below for patents covering OCUFEN around the world.

Country	Patent Number	Title	Estimated Expiration
France	5738
France	5737
Czechoslovakia	163156
Sweden	329843
France	1430359	Nouveaux dérivés de phénylalcanes et leur procédé de préparation

OCUFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ophthalmic Drugs: A Focus on Emerging Trends

Introduction to Ophthalmic Drugs Market

The ophthalmic drugs market is poised for significant growth, driven by increasing prevalence of eye disorders, advancements in drug delivery, and heightened research activities. Here, we will delve into the market dynamics and financial trajectories of key players and trends in the ophthalmic drugs sector.

Market Size and Growth Projections

The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023 and is projected to grow at a CAGR of 8.34% from 2024 to 2030[4].

Regional Market Analysis

Asia-Pacific Region

The Asia-Pacific region is expected to witness the fastest growth rate due to the increasing burden of ophthalmic disorders and rising consumer awareness. This region has the largest patient population but the lowest treatment rate, which is anticipated to drive market growth[1][4].

European Market

Europe is also expected to grow significantly, driven by key international companies with regional operations and increasing consumer awareness. Regulatory activities, such as the European Medicines Agency's workshops, and new drug approvals are further fueling market expansion[1].

Key Drivers of Market Growth

Rising Prevalence of Retinal Disorders

The increasing prevalence of retinal disorders globally is a significant driver. Anti-VEGF agents, which treat conditions causing swelling or growth of new blood vessels around the retina, led the market with 32.71% of global revenue in 2023[4].

Advancements in Drug Delivery

Advancements in drug delivery technologies are enhancing the efficacy and convenience of ophthalmic treatments. For instance, novel therapeutics and innovative delivery systems are being developed to treat various eye conditions[4].

Research and Development Investments

Public and private organizations are increasing their investments in research and development. For example, the National Eye Institute funded USD 2.5 million for glaucoma treatment research at Missouri University of Science and Technology in July 2023[4].

Financial Trajectory of Key Players

Oculis Holding AG

Oculis reported a cash position of $131.2 million as of June 30, 2024, which is expected to fund operations into the second half of 2026. The company's research and development expenses increased significantly due to ongoing clinical trials, including the DIAMOND-1 and DIAMOND-2 Phase 3 DME trials[2].

Ocular Therapeutix

Ocular Therapeutix had total cash and cash equivalents of $427.2 million as of September 30, 2024. The company expects its current cash balance to support its planned expenses into 2028. Net revenue from DEXTENZA sales is projected to be between $62.0 million and $67.0 million for 2024[3].

Ocuphire Pharma

As of March 31, 2023, Ocuphire Pharma had cash and cash equivalents of approximately $39.0 million, sufficient to fund operations into 2025. The company's revenue during the first quarter of 2023 was derived from the reimbursement of research and development services under the Nyxol License Agreement[5].

Clinical Trials and Pipeline Developments

Oculis Holding AG

Oculis is advancing several clinical trials, including OCS-01, OCS-02 (licaminlimab), and OCS-05. Positive advancements in the DIAMOND-1 and DIAMOND-2 Phase 3 DME trials are significant milestones[2].

Ocular Therapeutix

Ocular Therapeutix is conducting the SOL-1 and SOL-R Phase 3 clinical trials. The SOL-R trial is designed to complement SOL-1 with repeat and flexible dosing, providing commercially meaningful data. Topline data from the SOL-1 trial are expected during the fourth quarter of 2025[3].

Regulatory Approvals and Collaborations

European Medicines Agency Approvals

Bayer AG submitted a regulatory approval application for aflibercept 8 mg for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) to the European Medicines Agency in February 2023[4].

Collaborations and Licensing

Ocuphire Pharma's revenue is partly driven by collaborations, such as the Nyxol License Agreement, which reimburses the company for research and development services[5].

Market Penetration and End-User Concentration

Hospitals and Clinical Laboratories

Hospitals are preferred for ophthalmic care due to the availability of various services under one roof. The presence of a well-distributed network of clinical laboratories and hospitals is enabling improved market penetration of ophthalmic drugs[4].

Challenges and Opportunities

Increasing Consumer Awareness

Rising consumer awareness is a key factor driving market growth. Educational initiatives and regulatory workshops are crucial in this regard[1].

Novel Therapeutics and Technologies

The development of novel therapeutics and technologies, such as anti-VEGF agents and innovative drug delivery systems, presents significant opportunities for market expansion[4].

Key Takeaways

• The global ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030.
• The Asia-Pacific region is expected to witness the fastest growth rate due to the increasing burden of ophthalmic disorders.
• Key drivers include the rising prevalence of retinal disorders, advancements in drug delivery, and increasing research investments.
• Companies like Oculis, Ocular Therapeutix, and Ocuphire Pharma are making significant strides in clinical trials and pipeline developments.
• Regulatory approvals and collaborations are crucial for market growth.

FAQs

What is the projected growth rate of the global ophthalmic drugs market?

The global ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030[4].

Which region is expected to witness the fastest growth in the ophthalmic drugs market?

The Asia-Pacific region is expected to witness the fastest growth rate due to the increasing burden of ophthalmic disorders and rising consumer awareness[1][4].

What are the key drivers of the ophthalmic drugs market?

Key drivers include the rising prevalence of retinal disorders, advancements in drug delivery, and increasing research investments[4].

Which segment led the ophthalmic drugs market in 2023?

Anti-VEGF agents led the market and accounted for 32.71% of the global revenue in 2023[4].

How are regulatory approvals impacting the ophthalmic drugs market?

Regulatory approvals, such as those from the European Medicines Agency, are crucial for market growth by increasing drug supply and patient access[1][4].

Cited Sources

1. Straits Research: "Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030"[1]
2. GlobeNewswire: "Oculis Reports Q2 Financial Results and Provides Recent Company Update"[2]
3. Ocular Therapeutix: "Ocular Therapeutix™ Reports Third Quarter 2024 Results and Provides Corporate Update"[3]
4. Grand View Research: "Ophthalmic Drugs Market Size & Share | Industry Report 2030"[4]
5. Ocuphire Pharma: "Ocuphire Pharma Announces Financial Results for First Quarter 2023 and Provides Corporate Update"[5]