FDA Orange Book · active-ingredient family
Trimethoprim
Trimethoprim is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRIMETHOPRIM · NDA 018679
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIMETHOPRIMRLD | DR REDDYS LABS SA | NDA 018679 | AB | Jul 30, 1982 | |
| PROLOPRIM×2 | MONARCH PHARMS | NDA 017943 | — | Approved Prior to Jan 1, 1982 | |
| TRIMPEX×2 | ROCHE | NDA 017952 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIMETHOPRIM | NOVITIUM PHARMA | ANDA 216393 | AB | Oct 28, 2022 | |
| TRIMETHOPRIM | NOVEL LABS INC | ANDA 091437 | AB | Jun 15, 2011 | |
| TRIMETHOPRIM | TEVA | ANDA 071259 | — | Jun 18, 1987 | |
| TRIMETHOPRIM | SUN PHARM INDUSTRIES | ANDA 070495 | — | Sep 24, 1986 | |
| TRIMETHOPRIM | SUN PHARM INDUSTRIES | ANDA 070494 | — | Jan 22, 1986 | |
| TRIMETHOPRIM | WATSON LABS | ANDA 070049 | AB | Jun 06, 1985 |
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.
Trimethoprim — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
