FDA Orange Book · active-ingredient family
Difluprednate
Difluprednate: 1 brand, 8 generics; first approved Jun 23, 2008; generic available.
Generic available
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- SANDOZNDA 0222122008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- DIFLUPREDNATEALEMBICANDA 2137742026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATEMYLAN LABS LTDANDA 2125662025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATEUPSHER SMITH LABSANDA 2181912025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATECAPLINANDA 2194412024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATEEPIC PHARMA LLCANDA 2072842024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATEDR REDDYSANDA 2148942022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATEAMNEALANDA 2115262021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB - DIFLUPREDNATECIPLAANDA 2117762021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% EMULSION OPHTHALMIC Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
18 yr 5 mo ago
Most recent approval
7 mo ago
Approvals span 2008–2026 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Difluprednate: 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.
