Bromfenac sodium - Generic Drug Details
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What are the generic drug 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, Akorn, Alembic Pharms, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Rising, Sun Pharm, and Bausch And Lomb, and is included in thirteen 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 patent family members in fourteen countries.
Seven suppliers are listed for this compound.
Summary for bromfenac sodium
International Patents: | 30 |
US Patents: | 10 |
Tradenames: | 5 |
Applicants: | 12 |
NDAs: | 13 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 6 |
Patent Applications: | 719 |
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 |
Recent Clinical Trials for bromfenac sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seoul National University Hospital | Phase 2 |
Ministry of Health, China | N/A |
Sun Yat-sen University | N/A |
Pharmacology for bromfenac sodium
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for bromfenac sodium
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
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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bromfenac sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 602004013420 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2004064828 | See Plans and Pricing | |
Mexico | 2014004347 | COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2015170177 | See Plans and Pricing | |
European Patent Office | 2765988 | COMPOSITION CONTENANT BROMOFENAC À L'ADMINISTRATION À VOIE OCULAIRE AVEC UNE BIODISPONIBILITÉ AUGMENTÉ (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY) | See Plans and Pricing |
Portugal | 2403493 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bromfenac sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586316 | SPC/GB11/054 | United Kingdom | See Plans and Pricing | 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 | 1190018-0 | Sweden | See Plans and Pricing | RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22 |
1586316 | 2011C/027 | Belgium | See Plans and Pricing | PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523 |
1586316 | 11C0031 | France | See Plans and Pricing | PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
1586316 | C 2011 004 | Romania | See Plans and Pricing | 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 | 122011100019 | Germany | See Plans and Pricing | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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