Bromfenac Sodium Patent Expiration

Bromfenac Sodium is Used for managing ocular inflammation, postoperative inflammation, and reducing ocular pain in patients after cataract surgery. It was first introduced by Bausch And Lomb Inc in its drug Xibrom on Mar 24, 2005. Other drugs containing Bromfenac Sodium are Bromday, Bromsite, Prolensa. 14 different companies have introduced drugs containing Bromfenac Sodium.


Bromfenac Sodium Patents

Given below is the list of patents protecting Bromfenac Sodium, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Prolensa US9517220 Bromfenac bioavailability Nov 11, 2033 Bausch And Lomb
Prolensa US10085958 Bromfenac bioavailability Nov 19, 2032 Bausch And Lomb
Bromsite US8778999 Non-steroidal anti-inflammatory ophthalmic compositions Aug 07, 2029 Sun Pharm
Prolensa US8129431 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Sep 11, 2025 Bausch And Lomb
Prolensa US8669290 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb
Prolensa US8754131 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb
Prolensa US8871813 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb
Prolensa US8927606 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb
Prolensa US9144609 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb
Prolensa US9561277 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid Jan 16, 2024

(Expired)

Bausch And Lomb



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Bromfenac Sodium's patents.

Given below is the list recent legal activities going on the following patents of Bromfenac Sodium.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 22 May, 2024 US9517220
Payment of Maintenance Fee, 8th Year, Large Entity 22 Mar, 2023 US9144609(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 13 Jun, 2022 US8927606
Payment of Maintenance Fee, 4th Year, Large Entity 30 Mar, 2022 US10085958
Payment of Maintenance Fee, 8th Year, Large Entity 14 Mar, 2022 US8871813
Payment of Maintenance Fee, 8th Year, Large Entity 01 Dec, 2021 US8754131(Litigated)
Correspondence Address Change 30 Aug, 2021 US10085958
Correspondence Address Change 30 Aug, 2021 US9517220
Payment of Maintenance Fee, 8th Year, Large Entity 06 Aug, 2021 US8669290
Payment of Maintenance Fee, 4th Year, Large Entity 04 Jun, 2020 US9517220


Bromfenac Sodium's Family Patents

Family Patents

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Bromfenac Sodium Generic API Manufacturers

Several generic applications have been filed for Bromfenac Sodium. The first generic version for Bromfenac Sodium was by Coastal Pharmaceuticals and was approved on May 11, 2011. And the latest generic version is by Amneal Eu Ltd and was approved on Jul 29, 2024.

Given below is the list of companies who have filed for Bromfenac Sodium generic, along with the locations of their manufacturing plants worldwide.


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

(reference standard)

solution/drops Prescription OPHTHALMIC AT2 Jun 21, 2019
EQ 0.07% ACID

solution/drops Prescription OPHTHALMIC AB Jul 8, 2024


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





2. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.07% ACID

solution/drops Prescription OPHTHALMIC AB Jul 29, 2024


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





3. AMRING PHARMS

Amring Pharmaceuticals Inc has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Amring Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Discontinued OPHTHALMIC N/A Jan 9, 2013





4. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Discontinued OPHTHALMIC N/A Jun 23, 2014
EQ 0.07% ACID

solution/drops Prescription OPHTHALMIC AB Jul 8, 2024


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





5. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Discontinued OPHTHALMIC N/A Feb 10, 2015





6. COASTAL PHARMS

Coastal Pharmaceuticals has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Coastal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Discontinued OPHTHALMIC N/A May 11, 2011





7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Prescription OPHTHALMIC AT2 Mar 18, 2022


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





8. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Prescription OPHTHALMIC AT2 Mar 17, 2020





9. LUPIN LTD

Lupin Ltd has filed for 3 different strengths of generic version for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Prescription OPHTHALMIC AT2 Aug 15, 2023
EQ 0.07% ACID

solution/drops Prescription OPHTHALMIC AB Nov 22, 2023
EQ 0.075% ACID

solution/drops Prescription OPHTHALMIC AB Feb 2, 2024


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





10. RISING

Rising Pharma Holding Inc has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Discontinued OPHTHALMIC N/A Jun 3, 2019


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





11. SENTISS

Sentiss Ag has filed for 1 generic for Bromfenac Sodium. Given below are the details of the strengths of this generic introduced by Sentiss.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.09% ACID

solution/drops Prescription OPHTHALMIC AT2 Jan 22, 2014


Manufacturing Plant Locations
New

Sentiss's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Sentiss as present at those locations.

Country City Firm Name
India
District Solan Sentiss Pharma Pvt. Ltd.