FDA Orange Book · active-ingredient family
Desogestrel; ethinyl estradiol
Desogestrel; ethinyl estradiol is approved as 4 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CYCLESSA · NDA 021090
4
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYCLESSARLD | ASPEN GLOBAL INC | NDA 021090 | AB | Dec 20, 2000 | |
| MIRCETTERLD | TEVA BRANDED PHARM | NDA 020713 | — | Apr 22, 1998 | |
| ORTHO-CEPTRLD×2 | JANSSEN PHARMS | NDA 020301 | — | Dec 14, 1992 | |
| DESOGEN×2 | ORGANON USA INC | NDA 020071 | — | Dec 10, 1992 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESOGESTREL AND ETHINYL ESTRADIOL | ANNORA PHARMA | ANDA 219761 | AB | Mar 18, 2026 | |
| AVERI×2 | AVION PHARMS | ANDA 218933 | — | May 02, 2025 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | NAARI PTE | ANDA 207067 | AB | Sep 13, 2018 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | NAARI PTE | ANDA 209170 | AB | Jun 05, 2017 | |
| KALLIGA | AUROBINDO PHARMA | ANDA 207081 | AB | May 17, 2017 | |
| SIMLIYA | AUROBINDO PHARMA | ANDA 206853 | AB | Mar 22, 2017 | |
| VOLNEA | XIROMED | ANDA 202689 | AB | Sep 09, 2016 | |
| BEKYREE | LUPIN | ANDA 202226 | AB | Aug 12, 2015 | |
| ISIBLOOM | XIROMED | ANDA 202789 | AB | Aug 12, 2015 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | XIROMED | ANDA 202085 | — | May 20, 2015 | |
| KIMIDESS | PH HEALTH | ANDA 076681 | — | Apr 30, 2015 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | XIROMED | ANDA 202296 | AB | Aug 30, 2013 | |
| PIMTREA | NOVAST LABS | ANDA 091247 | AB | Aug 01, 2013 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | NOVAST LABS | ANDA 091234 | AB | Jul 12, 2013 | |
| ENSKYCE | LUPIN LTD | ANDA 201887 | AB | Mar 07, 2013 | |
| VIORELE | GLENMARK PHARMS LTD | ANDA 091346 | AB | Apr 02, 2012 | |
| EMOQUETTE | PH HEALTH | ANDA 076675 | — | Feb 25, 2011 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | DR REDDYS LABS SA | ANDA 076916 | — | Dec 29, 2008 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | DR REDDYS LABS SA | ANDA 077182 | — | Jan 24, 2006 | |
| DESOGESTREL AND ETHINYL ESTRADIOL | WATSON LABS | ANDA 076915 | AB | Jul 29, 2005 | |
| VELIVET | DURAMED PHARMS BARR | ANDA 076455 | AB | Feb 24, 2004 | |
| KARIVA | BARR | ANDA 075863 | AB | Apr 05, 2002 | |
| DESOGESTREL AND ETHINYL ESTRADIOL×2 | DURAMED PHARMS BARR | ANDA 075256 | — | Aug 12, 1999 |
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.
Desogestrel; ethinyl estradiol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
