FDA Orange Book · active-ingredient family
Desoximetasone
Desoximetasone is approved as 6 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOPICORT · NDA 204141
6
Brand (NDA)
34
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, gel, ointment, spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOPICORTRLD | SUN PHARMA CANADA | NDA 204141 | AT | Apr 11, 2013 | |
| TOPICORTRLD | TARO | NDA 018594 | AB | Jan 17, 1985 | |
| TOPICORTRLD | TARO | NDA 018763 | — | Sep 30, 1983 | |
| TOPICORTRLD | TARO | NDA 018586 | — | Mar 29, 1982 | |
| TOPICORTRLD | TARO | NDA 017856 | — | Approved Prior to Jan 1, 1982 | |
| TOPICORT LPRLD | TARO | NDA 018309 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESOXIMETASONE | COSETTE | ANDA 209595 | — | Mar 04, 2020 | |
| DESOXIMETASONE | RISING | ANDA 210980 | AB | Dec 21, 2018 | |
| DESOXIMETASONE | THE J MOLNER | ANDA 209973 | AB | Oct 23, 2018 | |
| DESOXIMETASONE | ZYDUS LIFESCIENCES | ANDA 205620 | AB | Sep 28, 2018 | |
| DESOXIMETASONE | RISING | ANDA 205594 | AB | Jul 02, 2018 | |
| DESOXIMETASONE | LUPIN | ANDA 208124 | AT | Mar 16, 2018 | |
| DESOXIMETASONE | ZYDUS LIFESCIENCES | ANDA 205206 | AB | Sep 19, 2017 | |
| DESOXIMETASONE | PADAGIS ISRAEL | ANDA 206441 | AT | Jan 20, 2017 | |
| DESOXIMETASONE | LUPIN | ANDA 208163 | AB | Jan 10, 2017 | |
| DESOXIMETASONE | LUPIN | ANDA 208164 | AB | Jan 09, 2017 | |
| DESOXIMETASONE | SCIEGEN PHARMS | ANDA 203787 | AB | Jan 06, 2017 | |
| DESOXIMETASONE | COSETTE | ANDA 206740 | — | Dec 23, 2016 | |
| DESOXIMETASONE | LUPIN | ANDA 208044 | AB | Dec 12, 2016 | |
| DESOXIMETASONE | LUPIN | ANDA 208104 | AB | Dec 01, 2016 | |
| DESOXIMETASONE | RISING | ANDA 204272 | AB | Nov 30, 2016 | |
| DESOXIMETASONE | ACTAVIS MID ATLANTIC | ANDA 204965 | AB | Nov 07, 2016 | |
| DESOXIMETASONE | RISING | ANDA 204675 | AB | Aug 12, 2016 | |
| DESOXIMETASONE | NOVEL LABS INC | ANDA 206792 | AB | May 10, 2016 | |
| DESOXIMETASONE | ENCUBE | ANDA 208101 | — | Feb 25, 2016 | |
| DESOXIMETASONE | ACTAVIS MID ATLANTIC | ANDA 205082 | AB | Sep 04, 2015 | |
| DESOXIMETASONE | SCIEGEN PHARMS | ANDA 203234 | AB | Jun 12, 2015 | |
| DESOXIMETASONE | PADAGIS ISRAEL | ANDA 077770 | AB | Apr 20, 2015 | |
| DESOXIMETASONE | EPIC PHARMA LLC | ANDA 201005 | AB | Apr 24, 2014 | |
| DESOXIMETASONE | GLENMARK PHARMS LTD | ANDA 202838 | — | Sep 20, 2013 | |
| DESOXIMETASONE | FOUGERA PHARMS | ANDA 078657 | AB | Sep 28, 2012 | |
| DESOXIMETASONE | EPIC PHARMA LLC | ANDA 090727 | AB | Mar 10, 2011 | |
| DESOXIMETASONE | FOUGERA PHARMS | ANDA 078369 | AB | Jun 29, 2010 | |
| DESOXIMETASONE | PADAGIS US | ANDA 077552 | — | Jan 09, 2006 | |
| DESOXIMETASONE | PADAGIS ISRAEL | ANDA 076510 | AB | Jul 01, 2003 | |
| TOPICORT | TARO | ANDA 074904 | AB | Jul 14, 1998 | |
| DESOXIMETASONE | ALTANA | ANDA 073440 | — | Apr 01, 1998 | |
| TOPICORT | TARO | ANDA 074286 | — | Jun 07, 1996 | |
| TOPICORT | TARO | ANDA 073210 | AB | Nov 30, 1990 | |
| TOPICORT | TARO | ANDA 073193 | AB | Nov 30, 1990 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8715624 | May 26, 2026 | 24 d ago | ProductU-1408 |
| 8277780 | Sep 01, 2028 | in 2 yr 3 mo | ProductU-1408 |
Desoximetasone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
