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RECORLEV

NDA

LEVOKETOCONAZOLE | N214133 | STRONGBRIDGE DUBLIN LTD

1 strength9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Expired (4)Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

May. 3, 2028

Jan. 10, 2026

Jan. 10, 2026

Jan. 10, 2026

Mar. 2, 2040

Mar. 2, 2040

Jan. 10, 2026

Mar. 2, 2040

Mar. 2, 2040

NCE*

Dec. 30, 2026

ODE-385

Dec. 30, 2028

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

3 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
XERIS PHARMACEUTICALS, INC. et al v. NOVITIUM PHARMA, LLC et al 2:2026cv06568 4 patentsANDA 221336levoketoconazole	D.N.J.	2026-06-04	Active	—
XERIS PHARMACEUTICALS, INC. et al v. SANDOZ INC. et al 2:2026cv02929 5 patentsANDA 220804, 220935levoketoconazole	D.N.J.	2026-03-20	Terminated 2026-06-08	—
XERIS PHARMACEUTICALS, INC. et al v. SOMERSET THERAPEUTICS, LLC et al 2:26-cv-02044 5 patentsANDA 221137, 220357levoketoconazole	D.N.J.	2026-02-26	Active	Julien Xavier Neals

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consultant Services, Inc. FDA-2026-P-8250 · 6 docket documents Lachman Consultant Services, Inc. filed a suitability petition requesting that the FDA determine whether potassium iodide in oral liquid dosage form is suitable for inclusion in an ANDA, enabling generic manufacturers to develop and commercialize this formulation.	Suitability	2026-07-28	Open	Lachman Consultant Services, Inc.

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

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug Interaction Study of Levoketoconazole and Metformin NCT03880825	Phase 1	Completed	Cortendo AB	32	2019-03-28 → 2019-05-03
Levoketoconazole Food Effect Study in Healthy Subjects NCT03768388	Phase 1	Completed	Cortendo AB	22	2018-11-30 → 2018-12-24
Bioavailability of Levoketoconazole and Ketoconazole Tablets NCT04212000	Phase 1	Completed	Cortendo AB	34	2019-12-16 → 2020-01-23
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.NCT03277690	Phase 3	Completed	Cortendo AB	84	2017-09-26 → 2020-08-31
Treatment for Endogenous Cushing's Syndrome NCT01838551	Phase 3	Completed	Cortendo AB	94	2014-08 → 2018-11
Open-label Treatment in Cushing's Syndrome NCT03621280	Phase 3	Completed	Cortendo AB	51	2019-01-07 → 2022-12-31

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 | 1 NDC (1 FSS)

Lowest Price

$10004.49

Highest Price

$10004.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72065-0003-01RECORLEV 150MG TAB	$10004.49	FSS	Xeris Pharmaceutical, Inc.	04/01/2026

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

Medicare Part D Spending

CMS annual spending data for Recorlev (2024)

Total Spending

$29.7M

Total Claims

1,112

Beneficiaries

228

Avg Cost/Unit

$376.77

Spending Trend

$2.4M(2022)→$9.8M(2023)→$29.7M(2024)

YoY Change:+6.1%

5yr CAGR:+12.5%

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

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

TORRENT PHARMACEUTICALS LTDLEVOKETOCONAZOLE

DMF 380852025

SS PHARMA LLCLEVOKETOCONAZOLE

DMF 381732023

PIRAMAL PHARMA LTDLEVOKETOCONAZOLE

DMF 389732023

OLON SPALEVOKETOCONAZOLE

DMF 422682025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 17, 2023	SUPPL -3	View Letter (PDF)
Jan 3, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 2021

Patents (9) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9918984	May 3, 2028	—	—	—	—
10098877	Jan 10, 2026	—	—	—	—
10517868	Jan 10, 2026	—	—	—	—
10835530	Jan 10, 2026	—	—	—	—
11020393	Mar 2, 2040	—	—	—	—
11278547	Mar 2, 2040	—	—	—	—
11478471	Jan 10, 2026	—	—	—	—
11903940	Mar 2, 2040	—	—	—	—
12377096	Mar 2, 2040	—	—	—	—

Exclusivities (2)

Code	Date	Status
NCE*	Dec 30, 2026	< 1 year
ODE-385	Dec 30, 2028	Active