Viewing data from:

ISTURISA

NDA

OSILODROSTAT PHOSPHATE | N212801 | RECORDATI RARE DISEASES INC

3 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expired (1)Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

May. 20, 2033

Jan. 13, 2031

Aug. 23, 2026

Jan. 13, 2031

Jul. 6, 2035

Oct. 12, 2035

ODE-286

Mar. 6, 2027

ODE-535

Apr. 15, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Annora Pharma Private Limited FDA-2026-P-4574 · 2 docket documents Annora Pharma Private Limited filed this petition requesting that the FDA determine whether ISTURSIA (osilodrostat) tablets 10 mg, NDA 212801, held by Recordati Rare Diseases Inc., was voluntarily withdrawn from the market for reasons of safety or efficacy, as the product is currently listed as disc	505(q)	2026-04-24	Open	Annora Pharma Private Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome NCT03708900	Phase 2	Recruiting	RECORDATI GROUP	12	2021-04-28 → 2027-07-21
Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 NCT03606408	Phase 2	Completed	RECORDATI GROUP	127	2018-10-05 → 2023-11-16
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome NCT02468193	Phase 2	Completed	Novartis Pharmaceuticals	9	2015-09-24 → 2018-10-29

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$6568.88

Highest Price

$28415.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55292-0320-60ISTURISA 1MG TAB	$6568.88	Big4	Recordati Rare Diseases, Inc.	04/14/2026
55292-0320-60ISTURISA 1MG TAB	$7999.84	FSS	Recordati Rare Diseases, Inc.	04/14/2026
55292-0321-60ISTURISA 5MG TAB	$28415.64	Big4	Recordati Rare Diseases, Inc.	04/14/2026
55292-0321-60ISTURISA 5MG TAB	$28415.64	FSS	Recordati Rare Diseases, Inc.	04/14/2026
55292-0330-60ISTURISA 1MG TAB	$6568.88	Big4	Recordati Rare Diseases, Inc.	04/14/2026
55292-0330-60ISTURISA 1MG TAB	$7999.84	FSS	Recordati Rare Diseases, Inc.	04/14/2026
55292-0331-60ISTURISA 5MG TAB	$28415.64	Big4	Recordati Rare Diseases, Inc.	04/14/2026
55292-0331-60ISTURISA 5MG TAB	$28415.64	FSS	Recordati Rare Diseases, Inc.	04/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Isturisa (2024)

Total Spending

$65.5M

Total Claims

2,284

Beneficiaries

328

Avg Cost/Unit

$249.21

Spending Trend

$2.2M(2020)→$9.5M(2021)→$17.1M(2022)→$34.6M(2023)→$65.5M(2024)

YoY Change:+10.2%

5yr CAGR:+12.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

RECORDATI INDUSTRIA CHIMICA AND FARMACEUTICA SPAOSILODROSTAT PHOSPHATE

DMF 409082025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2026	SUPPL -7	View Letter (PDF)
Jul 8, 2025	SUPPL -4	View Letter (PDF)
Apr 21, 2025	SUPPL -3	View Letter (PDF)
Mar 10, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE

RLD

6 patents2 exclusivities▴

TABLET;ORAL | Approved: Mar 6, 2020

Patents (6) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8314097	May 20, 2033	—	Yes	Yes	—	—
8609862	Jan 13, 2031	—	—	—		—
8835646	Aug 23, 2026	—	Yes	Yes	—	—
9434754	Jan 13, 2031	—	Yes	—	—	—
10143680	Jul 6, 2035	—	—	Yes	—	—
10709691	Oct 12, 2035	—	—	—		—

Exclusivities (2)

Code	Date	Status
ODE-286	Mar 6, 2027	< 1 year
ODE-535	Apr 15, 2032	Active

#002 — EQ 5MG BASE

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Mar 6, 2020

#003 — EQ 10MG BASE

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Mar 6, 2020