Orange Book product · Brand (NDA)
ENSTILAR
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
At a glance
Oct 16, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2015
10 yr 10 mo ago
Today
Patent 10130640 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10617698 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10660908 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10682364 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10688108 expires
Listed method-of-use patent (U-2627) expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10716799 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 9119781 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 9119781 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 9566286 expires
Listed drug product patent expiration.
Jun 10, 2031
in 5 yr 1 mo
Patent 10130640*PED expires
Listed listed patent expiration.
Dec 10, 2031
in 5 yr 7 mo
Patent 9119781*PED expires
Listed listed patent expiration.
Dec 10, 2031
in 5 yr 7 mo
Pharmaceutical detail
Active ingredient
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Strength
0.064%;0.005%
Dosage form
AEROSOL, FOAM
Route
TOPICAL
TE code
Not listed
Application
NDA 207589
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020WYNZORABrand (NDA)
NDA 213422 · MC2
- 2008TACLONEXBrand (NDA)
NDA 022185 · LEO PHARMA AS
- 2006TACLONEXBrand (NDA)
NDA 021852 · LEO PHARMA AS
- 2023CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 214688 · GLENMARK PHARMS LTD
- 2020CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 212367 · PADAGIS ISRAEL
- 2020CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 213269 · SUN PHARMA CANADA
- 2020CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 210765 · COSETTE PHARMS NC
- 2014CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 200174 · PADAGIS ISRAEL
- 2013CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 201615 · CHARTWELL RX
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10130640 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10617698 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10660908 | Jun 10, 2031 | in 5 yr 1 mo | ProductU-2627 |
| 10682364 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10688108 | Jun 10, 2031 | in 5 yr 1 mo | U-2627 |
| 10716799 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 9119781 | Jun 10, 2031 | in 5 yr 1 mo | ProductU-1761 |
| 9119781 | Jun 10, 2031 | in 5 yr 1 mo | ProductU-2627 |
| 9566286 | Jun 10, 2031 | in 5 yr 1 mo | Product |
| 10130640*PED | Dec 10, 2031 | in 5 yr 7 mo | |
| 9119781*PED | Dec 10, 2031 | in 5 yr 7 mo |
