rolapitant hydrochloride · Tersera · NDA 206500, 208399

Varubi

Earliest generic entry, as listed
9 Oct 2029

Blocked by patent: US 8361500.

Listed patents · 8 unexpired

PatentClaimsExpires
US 9101615use U-174114 Jul 2032
US 8361500product9 Oct 2029
US 8470842use U-174118 Jan 2029
US 7049320substance, product, use U-174119 Aug 2028
US 7563801product4 Apr 2027
US 7981905use U-17414 Apr 2027
US 8178550substance, product4 Apr 2027
US 8404702use U-17414 Apr 2027

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 · 2

NDA · productFormStrengthListed expiry
206500 · 001 · RLDtablet, oralEQ 90MG BASE9 Oct 2029
208399 · 001 · RLD · discontinuedemulsion, intravenousEQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)14 Jul 2032