FDA Orange Book · active-ingredient family
Dipivefrin hydrochloride
Dipivefrin hydrochloride: 1 brand, 3 generics; first approved Jun 30, 1994; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- ALLERGANNDA 018239—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- EPIC PHARMA LLCANDA 0743821995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION/DROPS OPHTHALMIC Discontinued — - DIPIVEFRIN HYDROCHLORIDEBAUSCH AND LOMBANDA 0741881995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION/DROPS OPHTHALMIC Discontinued — - DIPIVEFRIN HYDROCHLORIDEFALCON PHARMSANDA 0736361994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —
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
32 yr 7 mo ago
Most recent approval
31 yr 4 mo ago
Approvals span 1994–1995 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Dipivefrin hydrochloride: 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.
