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Last Updated: December 21, 2024

XIBROM Drug Patent Profile


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Which patents cover Xibrom, and when can generic versions of Xibrom launch?

Xibrom is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

The generic ingredient in XIBROM is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xibrom

A generic version of XIBROM was approved as bromfenac sodium by SENTISS on January 22nd, 2014.

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Summary for XIBROM
Drug patent expirations by year for XIBROM
Recent Clinical Trials for XIBROM

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

SponsorPhase
Sun Pharma Global FZEPhase 1/Phase 2
InSite VisionPhase 1/Phase 2
Frank A. Bucci, Jr., M.D.Phase 4

See all XIBROM clinical trials

US Patents and Regulatory Information for XIBROM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb Inc XIBROM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-001 Mar 24, 2005 DISCN Yes 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

Supplementary Protection Certificates for XIBROM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 SPC/GB11/054 United Kingdom ⤷  Subscribe 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 122011100019 Germany ⤷  Subscribe PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 C 2011 004 Romania ⤷  Subscribe PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316 11C0031 France ⤷  Subscribe PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

XIBROM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XIBROM

Introduction

XIBROM, a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use, has been a significant player in the ophthalmic drugs market. Here, we delve into the market dynamics and financial trajectory of XIBROM, highlighting its key features, market performance, and future prospects.

Product Overview

XIBROM (bromfenac ophthalmic solution) is used for the treatment of ocular inflammation and pain following cataract surgery. It is a nonsteroidal anti-inflammatory drug that works by inhibiting cyclooxygenase 1 and 2, thereby blocking prostaglandin synthesis, which is a key mediator of intraocular inflammation[5].

Market Position

XIBROM has established itself as a leading product in the ophthalmic NSAID market. Here are some key points that highlight its market position:

Market Share and Growth

  • XIBROM has been one of the fastest-growing branded ophthalmic products. In 2007, it was reported that XIBROM continued to be the #2 NSAID prescribed by ophthalmologists, with an 8.5% market share increase from August 2006 to August 2007[3].
  • The product's strong growth trajectory was evident in its sales figures; for instance, in the second quarter of 2007, XIBROM sales increased by 143% compared to the same period in 2006[3].

Clinical Significance

  • Clinical trials have demonstrated the efficacy of XIBROM in reducing ocular inflammation after cataract surgery. In two randomized, double-masked, placebo-controlled trials, XIBROM showed a significant effect in reducing ocular inflammation, with 62-66% of patients achieving complete absence of inflammation compared to 40-48% in the placebo group[5].

Financial Performance

The financial performance of XIBROM is closely tied to the overall financial health of its parent company, ISTA Pharmaceuticals.

Revenue Growth

  • In 2008, ISTA Pharmaceuticals reported a full-year net revenue increase of 41% to $83.1 million, with the fourth quarter showing a 47% increase over the same period in 2007. XIBROM was a major contributor to this growth, with its sales driving the company's revenue[2].
  • For the second quarter of 2007, XIBROM sales were $9.7 million, up from $4.0 million in the same period of 2006, representing a 143% increase[3].

Market Expansion

  • The significant market potential for XIBROM is underscored by the fact that three million cataract surgeries are performed annually in the U.S., providing a substantial patient pool for the product[3].

Competitive Landscape

XIBROM operates in a competitive ophthalmic drugs market, but its unique features and clinical efficacy have helped it maintain a strong position.

Key Competitors

  • Other notable ophthalmic NSAIDs include products like Acular, Voltaren, and Nevanac. However, XIBROM's once-daily or twice-daily dosing regimen and its nonsteroidal nature have differentiated it in the market[3].

Strategic Initiatives

  • ISTA Pharmaceuticals has been proactive in expanding its product portfolio and seeking regulatory approvals. For example, the company initiated Phase III clinical studies for a once-daily formulation of XIBROM and planned to file an NDA for this formulation in the second half of 2007[3].

Future Prospects

The future outlook for XIBROM is promising, driven by several factors:

Growing Demand for Ophthalmic Drugs

  • The global ophthalmic drugs market is projected to grow at a CAGR of 7.4% from 2022 to 2030, reaching USD 62.55 billion by 2030. This growth is driven by increasing prevalence of eye illnesses and advancements in ophthalmic treatments[1].

Expanding Patient Pool

  • The Asia-Pacific region, with its large patient population and growing healthcare infrastructure, is expected to be a significant growth driver. Although the treatment rate is currently low in this region, it presents a substantial opportunity for market expansion[1].

Regulatory Environment

  • New FDA guidelines and regulatory approvals continue to support the development and commercialization of ophthalmic drugs. For instance, the Prescription Drug User Fee Act provides a structured approach for evaluating the risks and benefits of these drugs in clinical studies[1].

Key Takeaways

  • Strong Market Position: XIBROM has established itself as a leading ophthalmic NSAID, driven by its clinical efficacy and market demand.
  • Financial Growth: The product has contributed significantly to the revenue growth of ISTA Pharmaceuticals.
  • Competitive Advantage: XIBROM's unique dosing regimen and nonsteroidal nature differentiate it in the market.
  • Future Prospects: The growing demand for ophthalmic drugs, expanding patient pool, and favorable regulatory environment bode well for XIBROM's future.

FAQs

  1. What is XIBROM used for? XIBROM is used for the treatment of ocular inflammation and pain following cataract surgery.

  2. How does XIBROM work? XIBROM works by inhibiting cyclooxygenase 1 and 2, thereby blocking prostaglandin synthesis, which is a key mediator of intraocular inflammation[5].

  3. What were the sales figures for XIBROM in 2007? In the second quarter of 2007, XIBROM sales were $9.7 million, up from $4.0 million in the same period of 2006, representing a 143% increase[3].

  4. What is the market potential for XIBROM? The significant market potential for XIBROM is underscored by the fact that three million cataract surgeries are performed annually in the U.S.[3].

  5. What are the future prospects for XIBROM? The future outlook for XIBROM is promising, driven by the growing demand for ophthalmic drugs, expanding patient pool, and favorable regulatory environment.

Sources

  1. Straits Research - Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030
  2. Gale - ISTA Pharmaceuticals Reports Fourth Quarter and Full-Year 2008
  3. ISTA Pharmaceuticals - ISTA Q3 07 Fact Sheet
  4. MarketsandMarkets - Global Ophthalmology Drugs & Devices Market
  5. FDA - XIBROMâ„¢ (bromfenac ophthalmic solution) 0.09% Label

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