Orange Book product · Brand (NDA)
TWIRLA
ETHINYL ESTRADIOL; LEVONORGESTREL
At a glance
Feb 14, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 14, 2020
6 yr 5 mo ago
Today
Patent 8747888 expires
Listed drug product patent expiration.
Jul 10, 2028
in 2 yr 1 mo
Patent 9050348 expires
Listed drug product patent expiration.
Jul 10, 2028
in 2 yr 1 mo
Patent 8246978 expires
Listed drug product patent expiration.
Aug 26, 2028
in 2 yr 3 mo
Pharmaceutical detail
Active ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Strength
0.03MG/24HR;0.12MG/24HR
Dosage form
SYSTEM
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 204017
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.
- 2020TYBLUMEBrand (NDA)
NDA 209405 · EXELTIS USA INC
- 2018BALCOLTRABrand (NDA)
NDA 208612 · AVION PHARMS
- 2013QUARTETTEBrand (NDA)
NDA 204061 · TEVA BRANDED PHARM
- 2008LOSEASONIQUEBrand (NDA)
NDA 022262 · TEVA BRANDED PHARM
- 2007LYBRELBrand (NDA)
NDA 021864 · WYETH PHARMS INC
- 2006SEASONIQUEBrand (NDA)
NDA 021840 · TEVA BRANDED PHARM
- 2003SEASONALEBrand (NDA)
NDA 021544 · TEVA BRANDED PHARM
- 1998PREVEN EMERGENCY CONTRACEPTIVE KITBrand (NDA)
NDA 020946 · TEVA BRANDED PHARM
- 1998LEVLITEBrand (NDA)
NDA 020860 · BAYER HLTHCARE
- 1997ALESSEBrand (NDA)
NDA 020683 · CADENCE HEALTH
- 1984TRIPHASIL-21Brand (NDA)
NDA 019192 · WYETH PHARMS
- 1982NORDETTE-21Brand (NDA)
NDA 018668 · TEVA BRANDED PHARM
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8747888 | Jul 10, 2028 | in 2 yr 1 mo | Product |
| 9050348 | Jul 10, 2028 | in 2 yr 1 mo | Product |
| 8246978 | Aug 26, 2028 | in 2 yr 3 mo | Product |
