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 |
| Ocular Therapeutix, Inc. | Phase 4 |
| Sight Medical Doctors PLLC | 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
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Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
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 | |
| 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 | ⤷ 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 | ⤷ 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 |
| 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 |
|---|---|---|---|
| Canada | 3043910 | PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2013055856 | ⤷ Sign Up | |
| Canada | 2944832 | PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID) | ⤷ Sign Up |
| Spain | 2301964 | ⤷ Sign Up | |
| Japan | 4500261 | ⤷ Sign Up | |
| European Patent Office | 2765988 | COMPOSITION CONTENANT BROMOFENAC À L'ADMINISTRATION À VOIE OCULAIRE AVEC UNE BIODISPONIBILITÉ AUGMENTÉ (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY) | ⤷ Sign Up |
| Mexico | 2016014404 | PREPARACION LIQUIDA ACUOSA QUE CONTIENE ACIDO 2-AMINO-3-(BROMOBENZOIL) FENILACETICO. (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)P HENYLACETIC 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 | 2011C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523 |
| 1586316 | 132011901975261 | Italy | ⤷ Sign Up | PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518 |
| 1586316 | 11C0031 | France | ⤷ Sign Up | PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
| 1586316 | 1190018-0 | Sweden | ⤷ Sign Up | RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22 |
| 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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