FDA Orange Book · active-ingredient family
Metoprolol succinate
Metoprolol succinate is approved as 2 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KAPSPARGO SPRINKLE · NDA 210428
2
Brand (NDA)
28
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KAPSPARGO SPRINKLERLD×4 | SPIL | NDA 210428 | — | Jan 26, 2018 | |
| TOPROL-XLRLD×4 | MELINTA THERAP | NDA 019962 | AB | Feb 05, 2001 |
Generic (ANDA) products (28)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METOPROLOL SUCCINATE×4 | ZHEJIANG JUTAI PHARM | ANDA 214110 | AB | May 15, 2026 | |
| METOPROLOL SUCCINATE×4 | IPCA LABS LTD | ANDA 206980 | AB | Jun 25, 2025 | |
| METOPROLOL SUCCINATE×4 | SUNSHINE | ANDA 214004 | AB | May 23, 2024 | |
| METOPROLOL SUCCINATE×4 | LUPIN | ANDA 209272 | — | Aug 15, 2023 | |
| METOPROLOL SUCCINATE×4 | GRANULES | ANDA 216509 | — | Aug 07, 2023 | |
| METOPROLOL SUCCINATE×4 | GRANULES | ANDA 216916 | AB | Jun 12, 2023 | |
| METOPROLOL SUCCINATE×4 | ACCORD HLTHCARE | ANDA 215637 | — | Oct 18, 2022 | |
| METOPROLOL SUCCINATE×4 | YICHANG HUMANWELL | ANDA 213854 | AB | Aug 01, 2022 | |
| METOPROLOL SUCCINATE×2 | PRINSTON INC | ANDA 210597 | — | Jan 04, 2022 | |
| METOPROLOL SUCCINATE×4 | ALKEM LABS LTD | ANDA 211143 | AB | Nov 25, 2020 | |
| METOPROLOL SUCCINATE×4 | HETERO LABS LTD III | ANDA 205541 | AB | Nov 06, 2020 | |
| METOPROLOL SUCCINATE×2 | PHARMADAX | ANDA 203028 | AB | Mar 31, 2020 | |
| METOPROLOL SUCCINATE×2 | PHARMADAX | ANDA 203699 | AB | Mar 30, 2020 | |
| METOPROLOL SUCCINATE×4 | VISUM PHARM | ANDA 207206 | AB | Dec 19, 2018 | |
| METOPROLOL SUCCINATE×3 | CIPLA | ANDA 207465 | AB | Oct 26, 2018 | |
| METOPROLOL SUCCINATE×4 | ZYDUS PHARMS | ANDA 203894 | AB | Mar 23, 2018 | |
| METOPROLOL SUCCINATE×4 | NOVAST LABS | ANDA 204106 | AB | Feb 06, 2018 | |
| METOPROLOL SUCCINATE×4 | ACTAVIS ELIZABETH | ANDA 204161 | AB | Nov 25, 2016 | |
| METOPROLOL SUCCINATE×2 | REDDYS | ANDA 078889 | AB | Aug 15, 2012 | |
| METOPROLOL SUCCINATE×2 | DR REDDYS LABS LTD | ANDA 090617 | AB | Aug 01, 2012 | |
| METOPROLOL SUCCINATE×4 | MYLAN PHARMS INC | ANDA 202033 | AB | Dec 15, 2011 | |
| METOPROLOL SUCCINATE×4 | WOCKHARDT BIO AG | ANDA 090615 | AB | Jul 22, 2010 | |
| METOPROLOL SUCCINATE×2 | ACTAVIS LABS FL INC | ANDA 077298 | — | Apr 15, 2010 | |
| METOPROLOL SUCCINATE×2 | ACTAVIS LABS FL INC | ANDA 076862 | — | Aug 03, 2009 | |
| METOPROLOL SUCCINATE | NESHER PHARMS | ANDA 077176 | — | May 14, 2008 | |
| METOPROLOL SUCCINATE | NESHER PHARMS | ANDA 077779 | — | Mar 20, 2008 | |
| METOPROLOL SUCCINATE×2 | NESHER PHARMS | ANDA 076640 | — | May 18, 2007 | |
| METOPROLOL SUCCINATE×4 | SANDOZ | ANDA 076969 | — | Jul 31, 2006 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9504655 | Jul 09, 2035 | in 9 yr 2 mo | Product |
| 9700530 | Jul 09, 2035 | in 9 yr 2 mo | Product |
Metoprolol succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
