FDA Orange Book · active-ingredient family
Itraconazole
Itraconazole is approved as 5 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOLSURA · NDA 208901
5
Brand (NDA)
14
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOLSURARLD | MAYNE PHARMA | NDA 208901 | — | Dec 11, 2018 | |
| ONMELRLD | SEBELA IRELAND LTD | NDA 022484 | — | Apr 29, 2010 | |
| SPORANOXRLD | JANSSEN PHARMS | NDA 020657 | — | Feb 21, 1997 | |
| SPORANOXRLD | JANSSEN PHARMS | NDA 020083 | AB | Sep 11, 1992 | |
| SPORANOX | JANSSEN PHARMS | NDA 020966 | — | Mar 30, 1999 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ITRACONAZOLE | ANNORA PHARMA | ANDA 212239 | AA | Sep 01, 2020 | |
| ITRACONAZOLE | APOTEX | ANDA 208481 | — | Aug 02, 2019 | |
| ITRACONAZOLE | STRIDES PHARMA | ANDA 206410 | — | Jul 02, 2019 | |
| ITRACONAZOLE | TORRENT | ANDA 209460 | AB | Aug 24, 2018 | |
| ITRACONAZOLE | ZYDUS PHARMS | ANDA 204672 | AB | Sep 19, 2017 | |
| ITRACONAZOLE | ALKEM LABS LTD | ANDA 208591 | AB | Jun 12, 2017 | |
| ITRACONAZOLE | JUBILANT GENERICS | ANDA 203445 | — | Feb 23, 2017 | |
| ITRACONAZOLE | ALEMBIC | ANDA 206741 | AB | Dec 13, 2016 | |
| ITRACONAZOLE | RISING | ANDA 205724 | AB | Dec 13, 2016 | |
| ITRACONAZOLE | AMNEAL PHARMS | ANDA 205080 | AB | Sep 26, 2016 | |
| ITRACONAZOLE | ACCORD HLTHCARE | ANDA 205991 | — | May 26, 2016 | |
| ITRACONAZOLE | AMNEAL PHARMS | ANDA 205573 | AA | Oct 30, 2015 | |
| ITRACONAZOLE | MYLAN PHARMS INC | ANDA 200463 | — | Jul 20, 2012 | |
| ITRACONAZOLE | SANDOZ | ANDA 076104 | AB | May 28, 2004 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8486456 | Oct 03, 2028 | in 2 yr 4 mo | ProductU-1054 |
| 10463740 | Jun 21, 2033 | in 7 yr 1 mo | ProductU-2453 |
| 9713642 | Jun 21, 2033 | in 7 yr 1 mo | U-2453 |
| 10806792 | Jun 21, 2033 | in 7 yr 1 mo | Product |
| 8921374 | Jun 21, 2033 | in 7 yr 1 mo | Product |
| 9272046 | Jun 21, 2033 | in 7 yr 1 mo | Product |
Itraconazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
