FDA Orange Book · active-ingredient family
Pyrimethamine
Pyrimethamine is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DARAPRIM · NDA 008578
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARAPRIMRLD | TILDE SCIENCES | NDA 008578 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PYRIMETHAMINE | AUROBINDO PHARMA LTD | ANDA 216983 | AB | Oct 25, 2022 | |
| PYRIMETHAMINE | TEVA PHARMS | ANDA 215506 | AB | Aug 13, 2021 | |
| PYRIMETHAMINE | ALVOGEN | ANDA 211271 | — | Jul 27, 2021 | |
| PYRIMETHAMINE | SANALUZ | ANDA 207127 | AB | Feb 28, 2020 |
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.
Pyrimethamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
