FDA Orange Book · active-ingredient family
Isosorbide mononitrate
Isosorbide mononitrate is approved as 3 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IMDUR · NDA 020225
3
Brand (NDA)
20
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMDURRLD×3 | SCHERING PLOUGH | NDA 020225 | — | Aug 12, 1993 | |
| MONOKETRLD×2 | OMNIVIUM PHARMS | NDA 020215 | AB | Jun 30, 1993 | |
| ISMO | PROMIUS PHARMA | NDA 019091 | — | Dec 30, 1991 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE×2 | ANI PHARMS | ANDA 075147 | AB | Mar 27, 2026 | |
| ISOSORBIDE MONONITRATE×3 | ZYDUS PHARMS | ANDA 218255 | — | Feb 15, 2024 | |
| ISOSORBIDE MONONITRATE×3 | SHANDONG | ANDA 214115 | AB | Feb 08, 2024 | |
| ISOSORBIDE MONONITRATE×3 | AUROBINDO PHARMA | ANDA 216557 | AB | Nov 07, 2022 | |
| ISOSORBIDE MONONITRATE×3 | RICONPHARMA LLC | ANDA 210918 | AB | Nov 05, 2018 | |
| ISOSORBIDE MONONITRATE | DEXCEL LTD | ANDA 210822 | AB | Aug 29, 2018 | |
| ISOSORBIDE MONONITRATE×3 | ACCORD HLTHCARE | ANDA 209684 | — | Oct 24, 2017 | |
| ISOSORBIDE MONONITRATE×2 | DEXCEL LTD | ANDA 075522 | AB | Sep 20, 2016 | |
| ISOSORBIDE MONONITRATE | TORRENT PHARMS | ANDA 200270 | AB | Jun 03, 2011 | |
| ISOSORBIDE MONONITRATE×2 | TORRENT PHARMS | ANDA 200495 | AB | Jun 03, 2011 | |
| ISOSORBIDE MONONITRATE×3 | STRIDES PHARMA INTL | ANDA 090598 | — | Aug 11, 2010 | |
| ISOSORBIDE MONONITRATE×2 | HIKMA INTL PHARMS | ANDA 076813 | — | Mar 30, 2006 | |
| ISOSORBIDE MONONITRATE×3 | IVAX SUB TEVA PHARMS | ANDA 075448 | — | Aug 07, 2001 | |
| ISOSORBIDE MONONITRATE | HIKMA PHARMS | ANDA 075361 | — | Oct 05, 2000 | |
| ISOSORBIDE MONONITRATE×3 | ZYDUS HLTHCARE | ANDA 075395 | AB | Mar 16, 2000 | |
| ISOSORBIDE MONONITRATE×3 | CHARTWELL MOLECULAR | ANDA 075155 | AB | Jan 13, 2000 | |
| ISOSORBIDE MONONITRATE | SKYEPHARMA AG | ANDA 075166 | — | Oct 07, 1999 | |
| ISOSORBIDE MONONITRATE×2 | ACTAVIS ELIZABETH | ANDA 075306 | — | Dec 31, 1998 | |
| ISOSORBIDE MONONITRATE×2 | GENUS | ANDA 075037 | AB | Oct 30, 1998 | |
| ISOSORBIDE MONONITRATE | ALKERMES GAINESVILLE | ANDA 075041 | — | Sep 22, 1998 |
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.
Isosorbide mononitrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
