FDA Orange Book · active-ingredient family
Ribavirin
Ribavirin is approved as 4 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REBETOL · NDA 021546
4
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for solution, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REBETOLRLD | SCHERING | NDA 021546 | — | Jul 29, 2003 | |
| COPEGUSRLD×2 | ROCHE | NDA 021511 | — | Dec 03, 2002 | |
| REBETOLRLD×2 | MERCK SHARP DOHME | NDA 020903 | — | Jul 25, 2001 | |
| VIRAZOLERLD | BAUSCH | NDA 018859 | — | Dec 31, 1985 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIBAVIRIN | NAVINTA LLC | ANDA 207366 | — | Oct 06, 2016 | |
| RIBAVIRIN×4 | BEXIMCO PHARMS USA | ANDA 202546 | — | Aug 12, 2014 | |
| RIBAVIRIN | AUROBINDO PHARMA | ANDA 079117 | AB | Sep 17, 2009 | |
| RIBAVIRIN | AUROBINDO PHARMA | ANDA 079111 | AB | Sep 17, 2009 | |
| RIBAVIRIN | SANDOZ | ANDA 077743 | AB | Oct 03, 2006 | |
| RIBAVIRIN×3 | CHARTWELL RX | ANDA 077456 | — | Dec 05, 2005 | |
| RIBAVIRIN | HERITAGE PHARMA AVET | ANDA 077053 | — | Dec 05, 2005 | |
| RIBAVIRIN×4 | ZYDUS PHARMS USA | ANDA 077094 | AB | Dec 05, 2005 | |
| RIBAVIRIN | ZYDUS PHARMS USA | ANDA 077224 | AB | Oct 28, 2005 | |
| RIBAVIRIN | TEVA | ANDA 076277 | — | Oct 04, 2004 | |
| RIBASPHERE | CHARTWELL RX | ANDA 076203 | — | Apr 06, 2004 | |
| RIBAVIRIN | CHARTWELL RX | ANDA 076192 | — | Apr 06, 2004 |
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.
Ribavirin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
