cobicistat · Gilead Sciences Inc · NDA 203094

Tybost

Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Apr 2033

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10039718 (pediatric extension).

Listed patents · 2 unexpired

4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10039718drug product6 Apr 2033
US 10039718 listing rowdrug product6 Oct 2032
US 10039718 listing rowpediatric extension · sets the listed date6 Apr 2033
US 8148374drug substance, drug product, use U-12793 Mar 2030
US 8148374 listing rowdrug substance, drug product, use U-12793 Sep 2029
US 8148374 listing rowpediatric extension3 Mar 2030

Exclusivities · 2 unexpired

NPPnew patient population20 Jun 2028
NSnew strength20 Jun 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 · 2

NDA · productFormStrengthListed expiry
203094 · 001 · RLD · discontinuedtablet, oral150MG6 Apr 2033
203094 · 002 · RLD · discontinuedtablet, oral90MG6 Apr 2033
Expired or delisted (1)
  • ODE-260 · 22 Aug 2026