ethinyl estradiol; levonorgestrel · Avion Pharms · NDA 208612
Balcoltra
Earliest generic entry, as listed
1 Jun 2027
Blocked by patent: US 7838042.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7838042 | substance, use U-3251 | 1 Jun 2027 |
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
- 24 Oct 2026Enters 12-month window basis: patent · 208612-0011 Jun 2027
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208612 · 001 · RLD | tablet, oral | 0.02MG;0.1MG | 1 Jun 2027 |