FDA Orange Book · active-ingredient family
Rizatriptan benzoate
Rizatriptan benzoate is approved as 3 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RIZAFILM · NDA 205394
3
Brand (NDA)
25
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIZAFILMRLD×2 | GENSCO | NDA 205394 | — | Feb 26, 2026 | |
| MAXALT-MLTRLD×2 | ORGANON | NDA 020865 | — | Jun 29, 1998 | |
| MAXALTRLD×2 | ORGANON LLC | NDA 020864 | — | Jun 29, 1998 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIZATRIPTAN BENZOATE×2 | UNICHEM | ANDA 207835 | — | Mar 07, 2017 | |
| RIZATRIPTAN BENZOATE×2 | UNICHEM | ANDA 207836 | — | Mar 07, 2017 | |
| RIZATRIPTAN BENZOATE×2 | PANACEA | ANDA 204722 | AB | Jan 11, 2017 | |
| RIZATRIPTAN BENZOATE×2 | ALKEM LABS LTD | ANDA 203269 | AB | Feb 18, 2016 | |
| RIZATRIPTAN BENZOATE×2 | JUBILANT GENERICS | ANDA 203334 | — | Oct 16, 2015 | |
| RIZATRIPTAN BENZOATE×2 | JUBILANT GENERICS | ANDA 203252 | — | Dec 31, 2014 | |
| RIZATRIPTAN BENZOATE×2 | MACLEODS PHARMS LTD | ANDA 203146 | AB | Sep 19, 2014 | |
| RIZATRIPTAN BENZOATE×2 | MACLEODS PHARMS LTD | ANDA 203147 | AB | Feb 11, 2014 | |
| RIZATRIPTAN BENZOATE×2 | AVET LIFESCIENCES | ANDA 204090 | — | Nov 26, 2013 | |
| RIZATRIPTAN BENZOATE×2 | APOTEX INC | ANDA 202477 | — | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | AUROBINDO PHARMA LTD | ANDA 203062 | AB | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | CHARTWELL RX | ANDA 078739 | — | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | GLENMARK PHARMS LTD | ANDA 201914 | — | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | NATCO PHARMA LTD | ANDA 203478 | — | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | INVAGEN PHARMS | ANDA 204339 | — | Jul 01, 2013 | |
| RIZATRIPTAN BENZOATE×2 | CHARTWELL RX | ANDA 077526 | AB | Mar 26, 2013 | |
| RIZATRIPTAN BENZOATE×2 | PHARMOBEDIENT | ANDA 078173 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | APOTEX INC | ANDA 202244 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | AUROBINDO PHARMA LTD | ANDA 202490 | AB | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | CREEKWOOD PHARMS | ANDA 202047 | AB | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | GLENMARK PHARMS LTD | ANDA 201967 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | NATCO PHARMA LTD | ANDA 200482 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | PHARMOBEDIENT | ANDA 201993 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | SANDOZ | ANDA 079230 | — | Dec 31, 2012 | |
| RIZATRIPTAN BENZOATE×2 | TEVA PHARMS | ANDA 077263 | AB | Dec 31, 2012 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9301948 | Jul 30, 2034 | in 8 yr 3 mo | SubstanceProduct |
Rizatriptan benzoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

