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Last Updated: September 22, 2020

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BROMFENAC SODIUM Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Bromfenac Sodium

A generic version of BROMFENAC SODIUM was approved as bromfenac sodium by HI TECH on January 22nd, 2014.

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Drug patent expirations by year for BROMFENAC SODIUM
Drug Prices for BROMFENAC SODIUM

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Recent Clinical Trials for BROMFENAC SODIUM

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SponsorPhase
Sun Yat-sen UniversityN/A
Ministry of Health, ChinaN/A
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Pharmacology for BROMFENAC SODIUM
Paragraph IV (Patent) Challenges for BROMFENAC SODIUM
Tradename Dosage Ingredient NDA Submissiondate
BROMSITE SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 206911 2017-10-25
PROLENSA SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 203168 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
Alembic Pharms Ltd BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 210560-001 Jun 21, 2019 AT2 RX No No   Start Trial   Start Trial   Start Trial
Hi Tech BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203395-001 Jan 22, 2014 AT2 RX No Yes   Start Trial   Start Trial   Start Trial
Apotex BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202620-001 Jun 23, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Johnson and Johnson
Moodys
McKinsey
Harvard Business School

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