PROLENSA Drug Patent Profile
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Which patents cover Prolensa, and when can generic versions of Prolensa launch?
Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-four patent family members in thirteen countries.
The generic ingredient in PROLENSA 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 Prolensa
A generic version of PROLENSA was approved as bromfenac sodium by SENTISS on January 22nd, 2014.
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Questions you can ask:
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Summary for PROLENSA
International Patents: | 24 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 5 |
Patent Applications: | 4,936 |
Drug Prices: | Drug price information for PROLENSA |
Drug Sales Revenues: | Drug sales revenues for PROLENSA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROLENSA |
What excipients (inactive ingredients) are in PROLENSA? | PROLENSA excipients list |
DailyMed Link: | PROLENSA at DailyMed |
Recent Clinical Trials for PROLENSA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Wyse Eyecare | Phase 4 |
Sight Medical Doctors PLLC | Phase 4 |
Ocular Therapeutix, Inc. | Phase 4 |
Pharmacology for PROLENSA
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for PROLENSA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROLENSA | Ophthalmic Solution | bromfenac sodium | 0.07% | 203168 | 1 | 2013-07-26 |
US Patents and Regulatory Information for PROLENSA
PROLENSA is protected by ten US patents.
Patents protecting PROLENSA
Bromfenac bioavailability
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patented Use: METHOD OF TREATING OCULAR INFLAMMATION
Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patented Use: METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Bromfenac bioavailability
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Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY
Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY
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 | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
>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 PROLENSA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bausch And Lomb | PROLENSA | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 203168-001 | Apr 5, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROLENSA
See the table below for patents covering PROLENSA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 122011100019 | ⤷ Sign Up | |
Mexico | 2014004347 | COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.) | ⤷ Sign Up |
China | 1700913 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROLENSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586316 | SPC/GB11/054 | United Kingdom | ⤷ Sign Up | 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 | C300494 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
1586316 | C 2011 004 | Romania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |