FDA Orange Book · active-ingredient family
Famciclovir
Famciclovir is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FAMVIR · NDA 020363
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FAMVIRRLD×3 | NOVARTIS | NDA 020363 | — | Dec 11, 1995 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FAMCICLOVIR×3 | HETERO LABS LTD V | ANDA 202438 | AB | Sep 10, 2014 | |
| FAMCICLOVIR×3 | MACLEODS PHARMS LTD | ANDA 201022 | AB | Jan 12, 2012 | |
| FAMCICLOVIR×3 | APOTEX | ANDA 091480 | AB | Jul 22, 2011 | |
| FAMCICLOVIR×3 | NATCO PHARMA | ANDA 201333 | — | Mar 24, 2011 | |
| FAMCICLOVIR×3 | AUROBINDO PHARMA LTD | ANDA 091114 | AB | Mar 21, 2011 | |
| FAMCICLOVIR×3 | CIPLA | ANDA 078278 | — | Mar 21, 2011 | |
| FAMCICLOVIR×3 | HIKMA | ANDA 090128 | — | Mar 21, 2011 | |
| FAMCICLOVIR×3 | TEVA PHARMS | ANDA 077487 | AB | Aug 24, 2007 |
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.
Famciclovir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
