Viewing data from:

TOLSURA

NDA

ITRACONAZOLE | N208901 | MAYNE PHARMA INTERNATIONAL PTY LTD

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

Today

Jun. 21, 2033

Jun. 21, 2033

Jun. 21, 2033

Jun. 21, 2033

Jun. 21, 2033

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tolsura (2023)

Total Spending

$769K

Total Claims

230

Beneficiaries

Avg Cost/Unit

$40.67

Spending Trend

$201K(2019)→$502K(2020)→$902K(2021)→$1.3M(2022)→$769K(2023)

YoY Change:+0.8%

5yr CAGR:+3.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs6 inactive

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

JANSSEN PHARMACEUTICA NVITRACONAZOLE (R051211) DRUG SUBSTANCE

DMF 107251994

W R GRACE AND CO -CONNITRACONAZOLE USP & PH EUR

DMF 126971997

QUIMICA SINTETICA SAITRACONAZOLE

DMF 130121998

NEULAND LABORATORIES LTDITRACONAZOLE USP

DMF 154452001

MATRIX PHARMACORP PRIVATE LTDITRACONAZOLE USP

DMF 177392004

ALIVUS LIFE SCIENCES LTDITRACONAZOLE USP

DMF 179462004

SMS PHARMACEUTICALS LTDITRACONAZOLE USP

DMF 255142011

COHANCE LIFESCIENCES LTDITRACONAZOLE USP

DMF 259862012

MURLI KRISHNA PHARMA PVT LTDITRACONAZOLE PELLETS 22.0 % W/W

DMF 274102013

VASUDHA PHARMA CHEM LTDITRACONAZOLE USP

DMF 352612020

LEE PHARMA LTDITRACONAZOLE USP

DMF 414562025

QUIMICA FINA FARMEX SA DE CVInactiveITRACONAZOLE

DMF 145071999

HETERO DRUGS LTDInactiveITRACONAZOLE

DMF 157282001

PIRAMAL HEALTHCARE LTDInactiveITRACONAZOLE

DMF 169052003

APOTECNIA SAInactiveITRACONAZOLE

DMF 172922004

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveITRACONAZOLE

DMF 179212004

ALP PHARM BEIJING CO LTDInactiveITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE)

DMF 236412010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 29, 2024	SUPPL -4	View Letter (PDF)
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 65MG

RLD

5 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 11, 2018

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8921374	Jun 21, 2033	—	—	Yes	—	—
9272046	Jun 21, 2033	—	—	Yes	—	—
9713642	Jun 21, 2033	—	—	—		—
10463740	Jun 21, 2033	—	—	Yes		—
10806792	Jun 21, 2033	—	—	Yes	—	—