Assyro AI

FDA Orange Book · active-ingredient family

Prednisolone acetate

Prednisolone acetate is approved as 7 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OMNIPRED · NDA 017469

7

Brand (NDA)

11

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, suspension, suspension/drops

ProductApplicantApplicationTEApproved
OMNIPREDRLDSANDOZNDA 017469ABApproved Prior to Jan 1, 1982
PRED FORTERLDABBVIENDA 017011ABApproved Prior to Jan 1, 1982
PRED MILDRLDABBVIENDA 017100—Approved Prior to Jan 1, 1982
FLO-PRED×2SUN PHARMA CANADANDA 022067—Jan 17, 2008
METICORTELONESCHERINGNDA 010255—Approved Prior to Jan 1, 1982
STERANEPFIZERNDA 011446—Approved Prior to Jan 1, 1982
ECONOPREDHARROW EYENDA 017468—Approved Prior to Jan 1, 1982

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
PREDNISOLONE ACETATEAMNEALANDA 218256ABJun 11, 2025
PREDNISOLONE ACETATELUPINANDA 216935ABAug 02, 2024
PREDNISOLONE ACETATE×2BEL MARANDA 083738—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATE×2CENT PHARMSANDA 084717—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEEPIC PHARMA LLCANDA 083032—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEEPIC PHARMA LLCANDA 084492—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEWATSON LABSANDA 083398—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEWATSON LABSANDA 083654—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEWATSON LABSANDA 083767—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEWATSON LABSANDA 083764—Approved Prior to Jan 1, 1982
PREDNISOLONE ACETATEWATSON LABSANDA 085781—Approved Prior to Jan 1, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7799331Oct 11, 2028in 2 yr 4 mo
ProductU-1068

Prednisolone acetate — frequently asked questions

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

Agent CTA Background

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