FDA Orange Book · active-ingredient family
Meropenem
Meropenem is approved as 3 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MEROPENEM · NDA 215212
3
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEROPENEMRLD | HQ SPCLT PHARMA | NDA 215212 | AP | Jul 26, 2023 | |
| MERREM IVRLD×2 | PFIZER | NDA 050706 | — | Jun 21, 1996 | |
| MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER×2 | B BRAUN MEDICAL | NDA 202106 | — | Apr 30, 2015 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEROPENEM | BROOKS STERISCIENCE | ANDA 219084 | AP | Jun 23, 2025 | |
| MEROPENEM×2 | QILU | ANDA 216424 | AP | Jul 22, 2024 | |
| MEROPENEM×2 | BROOKS STERISCIENCE | ANDA 216154 | AP | Aug 18, 2022 | |
| MEROPENEM×2 | HQ SPCLT PHARMA | ANDA 210773 | AP | Aug 16, 2019 | |
| MEROPENEM×2 | EUGIA PHARMA | ANDA 205835 | AP | Mar 27, 2017 | |
| MEROPENEM×2 | ACS DOBFAR SPA | ANDA 204139 | AP | Jun 09, 2016 | |
| MEROPENEM×2 | GLAND | ANDA 206141 | AP | Jun 08, 2016 | |
| MEROPENEM×2 | SAVIOR LIFETEC CORP | ANDA 206086 | AP | Apr 19, 2016 | |
| MEROPENEM×2 | AMNEAL PHARMS | ANDA 205883 | AP | Apr 12, 2016 | |
| MEROPENEM×2 | DAEWOONG PHARM CO | ANDA 204854 | — | Dec 18, 2015 | |
| MEROPENEM×2 | ACS DOBFAR | ANDA 091404 | AP | Oct 26, 2011 | |
| MEROPENEM×2 | SANDOZ | ANDA 091201 | — | Mar 29, 2011 | |
| MEROPENEM×2 | HOSPIRA INC | ANDA 090940 | — | Jun 22, 2010 |
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.
Meropenem — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
