BROMFENAC SODIUM - Generic Drug Details

What are the generic sources for bromfenac sodium and what is the scope of patent protection?

Bromfenac sodium is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Alembic, Amneal, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, Sentiss, Sun Pharm, and Bausch And Lomb, and is included in nineteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bromfenac sodium has thirty-three patent family members in sixteen countries.

Thirteen suppliers are listed for this compound.

Summary for BROMFENAC SODIUM

International Patents:	33
US Patents:	10
Tradenames:	5
Applicants:	14
NDAs:	19
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	6
Patent Applications:	382
Drug Prices:	Drug price trends for BROMFENAC SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BROMFENAC SODIUM
What excipients (inactive ingredients) are in BROMFENAC SODIUM?	BROMFENAC SODIUM excipients list
DailyMed Link:	BROMFENAC SODIUM at DailyMed

See drug prices for BROMFENAC SODIUM

Recent Clinical Trials for BROMFENAC SODIUM

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

Sponsor	Phase
Seoul National University Hospital	Phase 2
Sun Yat-sen University	N/A
Ministry of Health, China	N/A

See all BROMFENAC SODIUM clinical trials

Pharmacology for BROMFENAC SODIUM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BROMFENAC SODIUM

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BROMFENAC SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROMSITE	Ophthalmic Solution	bromfenac sodium	0.075%	206911	1	2017-10-25
PROLENSA	Ophthalmic Solution	bromfenac sodium	0.07%	203168	1	2013-07-26

US Patents and Regulatory Information for BROMFENAC SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	202620-001	Jun 23, 2014		DISCN	No	No
Lupin Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	211239-001	Feb 2, 2024	AB	RX	No	No
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	10,085,958		Y
Lupin Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206027-001	Nov 22, 2023	AB	RX	No	No
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560-001	Jun 21, 2019	AT2	RX	No	Yes

Expired US Patents for BROMFENAC SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005	4,910,225
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	9,144,609
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,669,290
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	9,561,277
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,927,606

International Patents for BROMFENAC SODIUM

Country	Patent Number	Title	Estimated Expiration
Mexico	348418	COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.)
Spain	2301964
Canada	3043910	PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID)
South Korea	101059711
Portugal	2403493

Supplementary Protection Certificates for BROMFENAC SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	132011901975261	Italy		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1586316	2011C/027	Belgium		PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	11C0031	France		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518

BROMFENAC SODIUM Market Analysis and Financial Projection Experimental

Bromfenac Sodium Market Dynamics and Financial Trajectory

Market Introduction

Bromfenac sodium, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for the symptomatic treatment of inflammatory diseases in the external and anterior ocular areas. Its mechanism of action involves inhibiting cyclooxygenase 1 and 2, thereby blocking prostaglandin synthesis, which are mediators of intraocular inflammation[5].

Market Growth Drivers

The bromfenac sodium market is poised for significant growth driven by several key factors:

Rising Incidences of Allergic Diseases

The increasing prevalence of allergic diseases and other ocular inflammatory conditions is a major driver for the market. As the population ages and the incidence of eye surgeries such as cataract surgeries rises, the demand for effective anti-inflammatory treatments like bromfenac sodium is expected to increase[1].

Increasing R&D Expenditure

Pharmaceutical companies are investing heavily in research and development, which includes the development and improvement of ophthalmic drugs like bromfenac sodium. This increased R&D expenditure is expected to lead to new product launches and enhancements, further driving market growth[1].

Emerging Biopharmaceutical Industries

The growth of biopharmaceutical industries in emerging nations is another significant factor. These regions offer lucrative opportunities due to their large patient populations and growing healthcare infrastructure[1].

Market Segmentation

The global bromfenac sodium market is segmented based on several criteria:

By Type

The market is segmented into original drugs and generic drugs. The generic segment is expected to grow significantly due to its cost-effectiveness and the expiration of patents for original drugs[1][4].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the high volume of surgical procedures performed in these settings[1][4].

Regional Framework

The market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics.

• North America: This region is expected to hold a significant share due to advanced healthcare infrastructure and high adoption rates of new treatments.
• Asia-Pacific: The APAC region is anticipated to show rapid growth due to the large patient population and increasing healthcare expenditure in countries like China and India[1][4].

Financial Trajectory

Market Size and Forecast

The global bromfenac sodium market was valued at US$ million in 2023 and is anticipated to reach US$ million by 2030, witnessing a significant Compound Annual Growth Rate (CAGR) during the forecast period of 2024-2030[4].

Revenue Forecast

The market size and revenue forecasts are provided in terms of sales volume (Kg) and revenue ($ millions), with historical data from 2019 to 2023 and forecast data from 2024 to 2030. This comprehensive analysis helps in understanding the market's financial trajectory and making informed business decisions[4].

Key Players and Competitive Landscape

The market is dominated by several key players, including Qilu Pharma, Senju Pharma, CISEN, Hi-Tech Pharma, Apotex Corp., Iskon Remedies, and Meizilin Pharma. These companies are focusing on organic growth strategies such as product launches and approvals, as well as inorganic strategies like acquisitions and partnerships to expand their market share[1][4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of bromfenac sodium. For instance, two phase 3 clinical trials showed that bromfenac ophthalmic solution 0.07% was clinically safe and effective in treating ocular inflammation and pain after cataract surgery, with a higher proportion of subjects achieving complete clearance of ocular inflammation and being pain-free compared to the placebo group[2][5].

Technological Trends and New Product Developments

The market is also driven by technological trends and new product developments. Advances in drug delivery systems and the development of new formulations are expected to enhance the market's growth potential. For example, the availability of bromfenac ophthalmic solution in different concentrations (e.g., 0.07% and 0.09%) caters to various clinical needs and improves patient outcomes[5].

Challenges and Restraints

Despite the growth drivers, the market faces some challenges:

• Regulatory Requirements: Strict regulatory requirements and the need for extensive clinical trials can slow down the approval process for new products.
• Side Effects: Although rare, side effects such as corneal erosion, corneal perforation, and epithelial breakdown can impact market growth[5].

PEST Analysis

A comprehensive PEST (Political, Economic, Social, and Technological) analysis is crucial for understanding the broader environment in which the bromfenac sodium market operates.

• Political: Government policies and regulations play a significant role in the pharmaceutical industry. Favorable policies can boost market growth.
• Economic: Economic factors such as healthcare expenditure and reimbursement policies influence the market's financial trajectory.
• Social: Increasing awareness about eye health and the growing aging population are social factors driving the market.
• Technological: Advances in medical technology and drug delivery systems are key technological factors[1].

Key Takeaways

• The bromfenac sodium market is expected to grow significantly due to rising incidences of allergic diseases and increasing R&D expenditure.
• The market is segmented into original and generic drugs, with generic drugs expected to grow rapidly.
• Key players are focusing on both organic and inorganic growth strategies.
• Clinical trials have demonstrated the efficacy and safety of bromfenac sodium.
• Technological trends and new product developments are enhancing market growth.

FAQs

Q: What is bromfenac sodium used for? Bromfenac sodium is used for the symptomatic treatment of inflammatory diseases in the external and anterior ocular areas, particularly for conditions such as ocular inflammation and pain after cataract surgery[1][5].

Q: What are the key drivers of the bromfenac sodium market? The key drivers include rising incidences of allergic diseases, increasing R&D expenditure, and the growth of biopharmaceutical industries in emerging nations[1].

Q: Which regions are expected to dominate the bromfenac sodium market? North America and Asia-Pacific are expected to be the dominant regions due to advanced healthcare infrastructure and a large patient population, respectively[1][4].

Q: What are the common side effects of bromfenac sodium? Common side effects include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown, although these are rare[5].

Q: How is the bromfenac sodium market segmented? The market is segmented by type (original and generic drugs) and distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies)[1][4].

Sources

1. The Insight Partners, "Bromfenac Sodium Market Key Players Analysis 2031"
2. PubMed, "Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery"
3. Stats and Data, "Global Bromfenac Sodium Market Industry Best Practices 2024-2031"
4. OpenPR, "Global Bromfenac Sodium Market Report 2024: Emerging Trends"
5. DailyMed, "BROMFENAC- bromfenac sodium solution/ drops"