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FDA Orange Book · active-ingredient family

Bromfenac sodium

Bromfenac sodium is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BROMSITE · NDA 206911

3

Brand (NDA)

16

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution/drops

ProductApplicantApplicationTEApproved
BROMSITERLDSUN PHARMNDA 206911ABApr 08, 2016
PROLENSARLDBAUSCH AND LOMBNDA 203168ABApr 05, 2013
BROMDAYRLD×2BAUSCH AND LOMB INCNDA 021664—Oct 16, 2010

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
BROMFENAC SODIUMAMNEALANDA 210962ABJul 29, 2024
BROMFENAC SODIUMALEMBICANDA 214340ABJul 08, 2024
BROMFENAC SODIUMAPOTEXANDA 207334ABJul 08, 2024
BROMFENAC SODIUMLUPINANDA 211239ABFeb 02, 2024
BROMFENAC SODIUMLUPINANDA 206027ABNov 22, 2023
BROMFENAC SODIUMLUPINANDA 202903AT2Aug 15, 2023
BROMFENAC SODIUMEUGIA PHARMAANDA 204813AT2Mar 18, 2022
BROMFENAC SODIUMGLANDANDA 211029AT2Mar 17, 2020
BROMFENAC SODIUMALEMBICANDA 210560AT2Jun 21, 2019
BROMFENAC SODIUMRISINGANDA 203368—Jun 03, 2019
BROMFENAC SODIUMCHARTWELL RXANDA 201941—Feb 10, 2015
BROMFENAC SODIUMAPOTEXANDA 202620—Jun 23, 2014
BROMFENAC SODIUMAPOTEXANDA 202435—Jun 19, 2014
BROMFENAC SODIUMSENTISSANDA 203395AT2Jan 22, 2014
BROMFENAC SODIUMAMRING PHARMSANDA 202030—Jan 09, 2013
BROMFENAC SODIUMCOASTAL PHARMSANDA 201211—May 11, 2011

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE50218Mar 05, 2029in 2 yr 9 mo
ProductU-1834
10085958Nov 19, 2032in 6 yr 6 mo
Product
9517220Nov 11, 2033in 7 yr 6 mo
U-1933

Bromfenac sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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