BROMFENAC SODIUM - Generic Drug Details
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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, 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 sixteen 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.
Ten suppliers are listed for this compound.
Summary for BROMFENAC SODIUM
International Patents: | 30 |
US Patents: | 10 |
Tradenames: | 5 |
Applicants: | 13 |
NDAs: | 16 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 6 |
Patent Applications: | 492 |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 202903-001 | Aug 15, 2023 | AT2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Coastal Pharms | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 201211-001 | May 11, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Gland Pharma Ltd | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 211029-001 | Mar 17, 2020 | AT2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bausch And Lomb Inc | XIBROM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 021664-001 | Mar 24, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BROMFENAC SODIUM
International Patents for BROMFENAC SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1700913 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid | ⤷ Try a Trial |
Japan | 4500261 | ⤷ Try a Trial | |
Austria | 393627 | ⤷ Try a Trial | |
Spain | 2301964 | ⤷ Try a Trial | |
South Korea | 101059711 | ⤷ Try a Trial | |
Portugal | 1586316 | ⤷ Try a Trial | |
European Patent Office | 2403493 | COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BROMFENAC SODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586316 | C 2011 004 | Romania | ⤷ Try a Trial | 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 | C300494 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
1586316 | 132011901975261 | Italy | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518 |
1586316 | 1190018-0 | Sweden | ⤷ Try a Trial | RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22 |
1586316 | SPC/GB11/054 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523 |
1586316 | 122011100019 | Germany | ⤷ Try a Trial | 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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