osilodrostat phosphate · Recordati Rare · NDA 212801

Isturisa

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

12 Oct 2035

Blocked by patent: US 10709691. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 5 unexpired

8 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10709691	use U-2770, U-4529	12 Oct 2035	2 listing rows
US 10709691 listing row	use U-2770 · sets the listed date	12 Oct 2035	listed 6 Aug 2020
US 10709691 listing row	use U-4529 · sets the listed date	12 Oct 2035	2 strengths · listed 6 Aug 2020
US 10143680	drug product	6 Jul 2035	3 strengths · listed 3 Apr 2020
US 8314097	drug substance, drug product	20 May 2033	2 listing rows
US 8314097 listing row	drug substance, drug product	27 Mar 2029	listed 3 Apr 2020
US 8314097 listing row	drug substance, drug product	20 May 2033	2 strengths · listed 3 Apr 2020
US 8609862	use U-2770, U-4529	13 Jan 2031	2 listing rows
US 8609862 listing row	use U-2770	13 Jan 2031	listed 3 Apr 2020
US 8609862 listing row	use U-4529	13 Jan 2031	2 strengths · listed 3 Apr 2020
US 9434754	drug substance	13 Jan 2031	3 strengths · listed 3 Apr 2020

Exclusivities · 2 unexpired

ODE-535	orphan drug (7 years)	15 Apr 2032
ODE-286	orphan drug (7 years)	6 Mar 2027

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 · 3

NDA · product	Form	Strength	Approved	Listed expiry
212801 · 001 · RLD	tablet, oral	EQ 1MG BASE	6 Mar 2020	12 Oct 2035
212801 · 002 · RLD	tablet, oral	EQ 5MG BASE	6 Mar 2020	12 Oct 2035
212801 · 003 · RLD · discontinued	tablet, oral	EQ 10MG BASE	6 Mar 2020	12 Oct 2035

Expired or delisted (1)

US 8835646 · substance, product · 23 Aug 2026