BROMFENAC SODIUM | N203168 | BAUSCH AND LOMB INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SENJU PHARMACEUTICAL CO., LTD et al v. AUROBINDO PHARMA USA INC. et al 9 patentsANDA 212964bromfenac ophthalmic solution | D.N.J. | 2019-06-03 | Terminated 2020-01-07 | — |
SENJU PHARMACEUTICAL CO., LTD. et al v. AMNEAL PHARMACEUTICALS LLC et al 1 patentANDA 210962bromfenac | D.N.J. | 2018-12-07 | Terminated 2019-01-03 | — |
SENJU PHARMACEUTICAL CO., LTD. et al v. HI-TECH PHARMACAL CO. INC. et al 6 patentsANDA 208985Bromfenac | D.N.J. | 2016-04-22 | Terminated 2017-02-16 | — |
SENJU PHARMACEUTICAL CO., LTD. et al v. WATSON LABORATORIES, INC. et al 1 patentANDA 206085Bromfenac | D.N.J. | 2016-03-18 | Terminated 2017-01-30 | — |
| D.N.J. | 2014-01-31 | Terminated 2016-08-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 - Draft Guidance on Bromfenac Sodium RE Suitability Petition fro... FDA-2023-P-4359 · 11 docket documents Pharmobedient Consulting, LLC filed a petition regarding bromfenac sodium requesting FDA guidance on the suitability of the drug substance for use in abbreviated new drug applications (ANDAs), specifically addressing regulatory reference eligibility and quality standards. | Suitability | 2023-10-05 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$115.49
per ml
Lowest NADAC/Unit
$12.97
per ml
Brand NDCs
1
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 24208060203PROLENSA 0.07% EYE DROPS | $115.49 | ML | Brand | $12.97 | 2026-06-17 |
| 82260060203BROMFENAC SODIUM 0.07% EYE DRP | $12.97 | ML | Generic | — | 2026-06-17 |
| 75907009303BROMFENAC SODIUM 0.07% EYE DRP | $12.97 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.