Orange Book product · Brand (NDA)
FEMLYV
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Jul 22, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 22, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Jul 22, 2027
in 1 yr 1 mo
Patent 12178824 expires
Listed drug product patent expiration.
Jun 24, 2041
in 15 yr 3 mo
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.02MG;1MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 218718
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.
- 2013LO MINASTRIN FEBrand (NDA)
NDA 204654 · APIL
- 2013MINASTRIN 24 FEBrand (NDA)
NDA 203667 · APIL
- 2013TAYTULLABrand (NDA)
NDA 204426 · APIL
- 2010LO LOESTRIN FEBrand (NDA)
NDA 022501 · APIL
- 2006LOESTRIN 24 FEBrand (NDA)
NDA 021871 · TEVA BRANDED PHARM
- 2005FEMHRTBrand (NDA)
NDA 021065 · APIL
- 1996ESTROSTEP 21Brand (NDA)
NDA 020130 · APIL
- —LOESTRIN 21 1.5/30Brand (NDA)
NDA 017875 · TEVA BRANDED PHARM
- —LOESTRIN 21 1/20Brand (NDA)
NDA 017876 · TEVA BRANDED PHARM
- —LOESTRIN FE 1.5/30Brand (NDA)
NDA 017355 · TEVA BRANDED PHARM
- 2023OSHIHGeneric (ANDA)
ANDA 216558 · AUROBINDO PHARMA
- 2022NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGeneric (ANDA)
ANDA 213418 · GLENMARK PHARMS LTD
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Jul 22, 2027
in 1 yr 1 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12178824 | Jun 24, 2041 | in 15 yr 3 mo | Product |
