ethinyl estradiol; levonorgestrel · Agile · NDA 204017
Twirla
Earliest generic entry, as listed
26 Aug 2028
Blocked by patent: US 8246978.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8246978 | product | 26 Aug 2028 |
| US 8747888 | product | 10 Jul 2028 |
| US 9050348 | product | 10 Jul 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204017 · 001 · RLD | system, transdermal | 0.01MG/24HR;0.04MG/24HR | 26 Aug 2028 |