drospirenone; estradiol · Bayer Hlthcare · NDA 021355
Angeliq
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 8906890.
FDA has approved 1 generic application (ANDA) for Angeliq, though its earliest generic-entry date is 22 Oct 2031 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 8906890 | drug product · sets the listed date | 22 Oct 2031 |
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 2026First generic approved · 021355-00128 Oct 2025
- 25 Oct 2026Generic approved · 021355-00128 Oct 2025
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021355 · 001 · RLD | tablet, oral | 0.25MG;0.5MG | 22 Oct 2031 |
| 021355 · 002 · RLD | tablet, oral | 0.5MG;1MG | open |