ethinyl estradiol; norethindrone acetate · Apil · NDA 022501
Lo Loestrin Fe
Blocked by patent: US 7704984. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Lo Loestrin Fe, though its earliest generic-entry date is 2 Feb 2029 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7704984 | use U-1090 · sets the listed date | 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
- Generic approved · ANDA 219324, Teva Pharms Inc · 022501-001Approved 22 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022501 · 001 · RLD | tablet, oral | 0.01MG,0.01MG;1MG,N/A | 2 Feb 2029 |