Orange Book product · Brand (NDA)
MINIVELLE
ESTRADIOL
At a glance
Oct 29, 2012
Approved
Brand (NDA)
Application
AB3
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2012
13 yr 10 mo ago
Today
Patent 9730900 expires
Listed method-of-use patent (U-2086) 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
0.05MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
AB3
Application
NDA 203752
Product number
003
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 (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9730900 | Jul 10, 2028 | in 2 yr 1 mo | U-2086 |
| 9833419 | Jul 10, 2028 | in 2 yr 1 mo | Product |
| 8231906 | Jul 04, 2030 | in 4 yr 1 mo | SubstanceProduct |
