FDA Orange Book · active-ingredient family
Rifampin
Rifampin is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RIFADIN · NDA 050627
3
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIFADINRLD | SANOFI AVENTIS US | NDA 050627 | AP | May 25, 1989 | |
| RIFADINRLD×2 | SANOFI AVENTIS US | NDA 050420 | — | Approved Prior to Jan 1, 1982 | |
| RIMACTANE | OXFORD PHARMS | NDA 050429 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIFAMPIN | HIKMA PHARMS | ANDA 205039 | AP | Mar 03, 2016 | |
| RIFAMPIN | WATSON PHARMS TEVA | ANDA 206736 | — | Jan 19, 2016 | |
| RIFAMPIN | FRESENIUS KABI USA | ANDA 091181 | AP | Aug 21, 2014 | |
| RIFAMPIN | AVET LIFESCIENCES | ANDA 204101 | — | Aug 18, 2014 | |
| RIFAMPIN×2 | LUPIN PHARMS | ANDA 090034 | AB | Aug 21, 2013 | |
| RIFAMPIN | EPIC PHARMA LLC | ANDA 065502 | AP | Sep 21, 2010 | |
| RIFAMPIN | MYLAN LABS LTD | ANDA 065421 | AP | May 22, 2008 | |
| RIFAMPIN×2 | CHARTWELL MOLECULAR | ANDA 065390 | AB | Mar 28, 2008 | |
| RIFAMPIN×2 | HIKMA | ANDA 065028 | — | Mar 14, 2001 | |
| RIFAMPIN | HIKMA | ANDA 064217 | AP | Oct 29, 1999 | |
| RIFAMPIN×2 | EPIC PHARMA LLC | ANDA 064150 | AB | Jan 02, 1998 |
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.
Rifampin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
