FDA Orange Book · active-ingredient family
Bromfenac sodium
Bromfenac sodium: 3 brands, 16 generics; first approved Mar 24, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
3
Next patent expiry
Mar 05, 2029
in 2 yr 7 mo
Brand (NDA) products
Originator applications
- SUN PHARMNDA 2069112016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.075% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BAUSCH AND LOMBNDA 2031682013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.07% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMDAYRLDBAUSCH AND LOMB INCNDA 02166420102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- BROMFENAC SODIUMAMNEALANDA 2109622024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.07% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMFENAC SODIUMALEMBICANDA 2143402024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.07% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMFENAC SODIUMAPOTEXANDA 2073342024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.07% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMFENAC SODIUMLUPINANDA 2112392024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.075% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMFENAC SODIUMLUPINANDA 2060272023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.07% ACID SOLUTION/DROPS OPHTHALMIC Rx AB - BROMFENAC SODIUMLUPINANDA 2029032023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Rx AT2 - BROMFENAC SODIUMEUGIA PHARMAANDA 2048132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Rx AT2 - BROMFENAC SODIUMGLANDANDA 2110292020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Rx AT2 - BROMFENAC SODIUMRSALEMBICANDA 2105602019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Rx AT2 - BROMFENAC SODIUMRISINGANDA 2033682019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — - BROMFENAC SODIUMCHARTWELL RXANDA 2019412015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — - BROMFENAC SODIUMAPOTEXANDA 2026202014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — - BROMFENAC SODIUMAPOTEXANDA 2024352014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — - BROMFENAC SODIUMSENTISSANDA 2033952014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Rx AT2 - BROMFENAC SODIUMAMRING PHARMSANDA 2020302013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued — - BROMFENAC SODIUMCOASTAL PHARMSANDA 2012112011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09% ACID SOLUTION/DROPS OPHTHALMIC Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| RE50218 | in 2 yr 7 mo | ProductU-1834 | |
| 10085958 | in 6 yr 4 mo | Product | |
| 9517220 | in 7 yr 4 mo | U-1933 |
Approval history
FDA approval span
First approval
21 yr 9 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 2005–2024 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Bromfenac sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
