FDA Orange Book · active-ingredient family
Methylergonovine maleate
Methylergonovine maleate is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:METHERGINE · NDA 006035
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHERGINERLD×2 | EDISON THERAPS LLC | NDA 006035 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLERGONOVINE MALEATE | RISING | ANDA 211919 | AB | Jan 15, 2021 | |
| METHYLERGONOVINE MALEATE | TP ANDA HOLDINGS | ANDA 212233 | AB | May 01, 2020 | |
| METHYLERGONOVINE MALEATE | TEVA PHARMS USA | ANDA 211455 | AB | Mar 20, 2019 | |
| METHYLERGONOVINE MALEATE | AMNEAL PHARMS | ANDA 211483 | AB | Sep 10, 2018 | |
| METHYLERGONOVINE MALEATE | GRANULES | ANDA 210424 | AB | May 15, 2018 | |
| METHYLERGONOVINE MALEATE | CHARTWELL RX | ANDA 091577 | AB | May 02, 2011 | |
| METHYLERGONOVINE MALEATE | BRECKENRIDGE | ANDA 040889 | AP | Sep 13, 2010 | |
| METHYLERGONOVINE MALEATE | AM REGENT | ANDA 090193 | AP | Nov 24, 2008 |
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.
Methylergonovine maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
