BROMFENAC SODIUM Drug Patent Profile
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Which patents cover Bromfenac Sodium, and what generic alternatives are available?
Bromfenac Sodium is a drug marketed by Alembic, Amneal, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, and Sentiss. and is included in sixteen NDAs.
The generic ingredient in BROMFENAC SODIUM 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 Bromfenac Sodium
A generic version of BROMFENAC SODIUM was approved as bromfenac sodium by SENTISS on January 22nd, 2014.
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Summary for BROMFENAC SODIUM
Recent Clinical Trials for BROMFENAC SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Seoul National University Hospital | Phase 2 |
| Sun Yat-sen University | N/A |
| Ministry of Health, China | N/A |
Pharmacology for BROMFENAC SODIUM
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BROMFENAC SODIUM
Paragraph IV (Patent) Challenges for BROMFENAC SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BROMSITE | Ophthalmic Solution | bromfenac sodium | 0.075% | 206911 | 1 | 2017-10-25 |
| PROLENSA | Ophthalmic Solution | bromfenac sodium | 0.07% | 203168 | 1 | 2013-07-26 |
US Patents and Regulatory Information for BROMFENAC SODIUM
BROMFENAC SODIUM is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting BROMFENAC SODIUM
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 214340-001 | Jul 8, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 202620-001 | Jun 23, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amring Pharms | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 202030-001 | Jan 9, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 206027-001 | Nov 22, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
