FDA Orange Book · active-ingredient family
Methylprednisolone acetate
Methylprednisolone acetate is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEPO-MEDROL · NDA 011757
3
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · enema, injectable, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEPO-MEDROLRLD×3 | PFIZER | NDA 011757 | — | Approved Prior to Jan 1, 1982 | |
| MEDROL | PHARMACIA AND UPJOHN | NDA 018102 | — | Approved Prior to Jan 1, 1982 | |
| MEDROL ACETATE×2 | PHARMACIA AND UPJOHN | NDA 012421 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE×2 | CAPLIN | ANDA 220556 | AB | Jan 26, 2026 | |
| METHYLPREDNISOLONE ACETATE | HIKMA | ANDA 219145 | AB | Apr 16, 2025 | |
| METHYLPREDNISOLONE ACETATE×2 | AMNEAL | ANDA 216502 | AB | Nov 03, 2023 | |
| METHYLPREDNISOLONE ACETATE×2 | WILSHIRE PHARMS INC | ANDA 214870 | AB | May 10, 2023 | |
| METHYLPREDNISOLONE ACETATE×2 | EUGIA PHARMA | ANDA 211930 | AB | Apr 13, 2023 | |
| METHYLPREDNISOLONE ACETATE×2 | PH HEALTH | ANDA 214297 | AB | Jan 21, 2022 | |
| METHYLPREDNISOLONE ACETATE×2 | AMNEAL | ANDA 210043 | AB | May 20, 2019 | |
| METHYLPREDNISOLONE ACETATE×3 | SAGENT PHARMS INC | ANDA 201835 | — | Jun 27, 2018 | |
| METHYLPREDNISOLONE ACETATE×2 | SANDOZ | ANDA 040794 | AB | Mar 05, 2009 | |
| METHYLPREDNISOLONE ACETATE×2 | SANDOZ | ANDA 040719 | AB | Jan 29, 2009 | |
| METHYLPREDNISOLONE ACETATE×2 | TEVA PHARMS USA | ANDA 040620 | — | Oct 27, 2006 | |
| METHYLPREDNISOLONE ACETATE×2 | HONG KONG | ANDA 040557 | AB | Feb 23, 2005 | |
| METHYLPREDNISOLONE ACETATE×2 | EPIC PHARMA LLC | ANDA 086903 | — | Oct 20, 1982 | |
| M-PREDROL | BEL MAR | ANDA 086666 | — | Approved Prior to Jan 1, 1982 | |
| M-PREDROL | BEL MAR | ANDA 087135 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 085597 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 087248 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 085374 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 085600 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 085595 | — | Approved Prior to Jan 1, 1982 | |
| METHYLPREDNISOLONE ACETATE | WATSON LABS | ANDA 086507 | — | Approved Prior to Jan 1, 1982 |
Listed patents
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.
Methylprednisolone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
