FDA Orange Book · active-ingredient family
Methimazole
Methimazole is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAPAZOLE · NDA 007517
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAPAZOLERLD×2 | KING PHARMS | NDA 007517 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHIMAZOLE×2 | SQUARE PHARMS PLC | ANDA 218830 | AB | Feb 05, 2025 | |
| METHIMAZOLE×2 | BIONPHARMA | ANDA 218149 | AB | Sep 25, 2023 | |
| METHIMAZOLE×2 | MACLEODS PHARMS LTD | ANDA 209827 | AB | May 24, 2023 | |
| METHIMAZOLE×2 | RISING | ANDA 202068 | AB | Mar 07, 2012 | |
| METHIMAZOLE×2 | HERITAGE PHARMA | ANDA 040734 | AB | Dec 14, 2007 | |
| METHIMAZOLE×2 | SUN PHARM INDS INC | ANDA 040870 | — | Sep 25, 2007 | |
| METHIMAZOLE | DISCOVERY THERAP | ANDA 040619 | — | Jul 12, 2005 | |
| METHIMAZOLE×3 | AIPING PHARM INC | ANDA 040547 | AB | Feb 18, 2005 | |
| METHIMAZOLE×2 | CHARTWELL RX | ANDA 040411 | AB | Mar 27, 2001 | |
| TAPAZOLE×2 | KING PHARMS LLC | ANDA 040320 | — | Mar 31, 2000 | |
| METHIMAZOLE×3 | MYLAN | ANDA 040350 | AB | Mar 29, 2000 |
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.
Methimazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
