Orange Book product · Brand (NDA)
MINIVELLE
ESTRADIOL
At a glance
Sep 23, 2014
Approved
Brand (NDA)
Application
AB3
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 23, 2014
11 yr 11 mo ago
Today
Patent 9724310 expires
Listed drug substance patent expiration.
Jul 10, 2028
in 2 yr 1 mo
Patent 9730900 expires
Listed drug product patent expiration.
Jul 10, 2028
in 2 yr 1 mo
Patent 9833419 expires
Listed drug product patent expiration.
Jul 10, 2028
in 2 yr 1 mo
Patent 8231906 expires
Listed drug substance patent expiration.
Jul 04, 2030
in 4 yr 1 mo
Pharmaceutical detail
Active ingredient
ESTRADIOL
Strength
0.025MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB3
Application
NDA 203752
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2018IMVEXXYBrand (NDA)
NDA 208564 · MAYNE PHARMA
- 2007EVAMISTBrand (NDA)
NDA 022014 · PADAGIS US
- 2007DIVIGELBrand (NDA)
NDA 022038 · VERTICAL PHARMS
- 2006ELESTRINBrand (NDA)
NDA 021813 · VIATRIS
- 2004MENOSTARBrand (NDA)
NDA 021674 · BAYER HLTHCARE
- 2004ESTROGELBrand (NDA)
NDA 021166 · ASCEND THERAPS US
- 2002VIVELLE-DOTBrand (NDA)
NDA 020538 · SANDOZ
- 2002ALORABrand (NDA)
NDA 020655 · ABBVIE
- 2000VIVELLEBrand (NDA)
NDA 020323 · SANDOZ
- 1999ESTRADIOLBrand (NDA)
NDA 021048 · ORTHO MCNEIL PHARM
- 1999CLIMARABrand (NDA)
NDA 020375 · BAYER HLTHCARE
- 1998ESCLIMBrand (NDA)
NDA 020847 · WOMEN FIRST HLTHCARE
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9724310 | Jul 10, 2028 | in 2 yr 1 mo | SubstanceProduct |
| 9730900 | Jul 10, 2028 | in 2 yr 1 mo | ProductU-2086 |
| 9833419 | Jul 10, 2028 | in 2 yr 1 mo | Product |
| 8231906 | Jul 04, 2030 | in 4 yr 1 mo | SubstanceProduct |
