FDA Orange Book · active-ingredient family
Betamethasone dipropionate; calcipotriene
Betamethasone dipropionate; calcipotriene is approved as 4 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:WYNZORA · NDA 213422
4
Brand (NDA)
6
Generics (ANDA)
13
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, foam, cream, ointment, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| WYNZORARLD | MC2 | NDA 213422 | — | Jul 20, 2020 | |
| ENSTILARRLD | LEO PHARMA AS | NDA 207589 | — | Oct 16, 2015 | |
| TACLONEXRLD | LEO PHARMA AS | NDA 022185 | AB | May 09, 2008 | |
| TACLONEXRLD | LEO PHARMA AS | NDA 021852 | AB | Jan 09, 2006 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | GLENMARK PHARMS LTD | ANDA 214688 | — | Mar 21, 2023 | |
| CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE | PADAGIS ISRAEL | ANDA 212367 | — | Sep 11, 2020 | |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 213269 | AB | Sep 02, 2020 | |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | COSETTE PHARMS NC | ANDA 210765 | AB | May 11, 2020 | |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | PADAGIS ISRAEL | ANDA 200174 | AB | Dec 12, 2014 | |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | CHARTWELL RX | ANDA 201615 | — | Jan 14, 2013 |
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10265265 | Sep 27, 2027 | in 1 yr 4 mo | Product |
| 9119781 | Jun 10, 2031 | in 5 yr 1 mo | ProductU-1761 |
| 10688108 | Jun 10, 2031 | in 5 yr 1 mo | U-2627 |
| 10660908 | Jun 10, 2031 | in 5 yr 1 mo | ProductU-2627 |
| 9566286 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10130640 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10617698 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10682364 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10716799 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 9119781*PED | Dec 10, 2031 | in 5 yr 7 mo | |
| 10130640*PED | Dec 10, 2031 | in 5 yr 7 mo | |
| 12440499 | Mar 18, 2039 | in 12 yr 11 mo | ProductU-1408 |
| 11696919 | Mar 18, 2039 | in 12 yr 11 mo | Product |
Betamethasone dipropionate; calcipotriene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
