copper · Sebela Womens Hlth · NDA 218201

Miudella

Earliest generic entry, as listed
23 Jan 2037

Blocked by patent: US 10918516.

Listed patents · 14 unexpired

PatentClaimsExpires
US 10918516drug product · sets the listed date23 Jan 2037
US 11207209drug product16 Aug 2034
US 10166141drug product13 Jun 2034
US 9265652use U-415528 Apr 2034
US 10022264drug product22 Mar 2034
US 9180040drug product22 Mar 2034
US 10398588drug product, use U-415524 Feb 2034
US 9610191use U-415524 Feb 2034
US 12138199drug product18 Oct 2033
US 9089418drug product9 Apr 2033
US 10159596drug product14 Aug 2032
US 10188546drug product14 Aug 2032
US 11850181drug product14 Aug 2032
US 9427351drug product14 Aug 2032

Exclusivities · 1 unexpired

NPnew product24 Feb 2028

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
218201 · 001 · RLDsystem, intrauterineN/A23 Jan 2037