ethinyl estradiol; norethindrone acetate · Apil · NDA 022501
Lo Loestrin Fe
Earliest generic entry, as listed
2 Feb 2029
Blocked by patent: US 7704984. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7704984 | use U-1090 | 2 Feb 2029 |
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
- 25 Oct 2026Generic approved · 022501-00122 Jun 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022501 · 001 · RLD | tablet, oral | 0.01MG,0.01MG;1MG,N/A | 2 Feb 2029 |