ulipristal acetate · Lab Hra Pharma · NDA 022474

Ella

Earliest generic entry, as listed
12 Jun 2030

Blocked by patent: US 8426392, US 8962603. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 8 unexpired

PatentClaimsExpires
US 8426392use U-1389 · sets the listed date12 Jun 2030
US 8962603use U-1657 · sets the listed date12 Jun 2030
US 8512745drug product2 Jun 2030
US 10159681use U-251013 Apr 2030
US 10772897use U-295813 Apr 2030
US 9283233use U-182113 Apr 2030
US 8735380drug product20 Feb 2029
US 9844510drug product8 Dec 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 · productFormStrengthListed expiry
022474 · 001 · RLDtablet, oral30MG12 Jun 2030