Viewing data from:

SOAANZ

NDA

TORSEMIDE | N213218 | SARFEZ PHARMACEUTICALS INC

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

10154963

Oct. 6, 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 Soaanz (2023)

Total Spending

$4.8M

Total Claims

10,270

Beneficiaries

4,604

Avg Cost/Unit

$9.29

Spending Trend

$1.3M(2022)→$4.8M(2023)

YoY Change:+10.7%

5yr CAGR:+10.7%

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

API Supply Chain13 active DMFs5 inactive

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

COSMA SPATORSEMIDE 1016

DMF 155622001

COSMA SPATORSEMIDE 1024

DMF 155632001

TAPI NL BVTORSEMIDE

DMF 157382001

CAMBREX CHARLES CITY INCTORSEMIDE USP

DMF 174892004

HETERO LABS LTDTORSEMIDE

DMF 183602007

BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPATORSEMIDE (MOD 1) BULK SUBSTANCE

DMF 192372006

ZHEJIANG DONGDONG PHARMACEUTICAL CO LTDTORSEMIDE

DMF 215762008

APITORIA PHARMA PRIVATE LTDTORSEMIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 231742009

IPCA LABORATORIES LTDTORSEMIDE USP

DMF 237602010

JARI PHARMACEUTICAL CO LTDTORSEMIDE

DMF 274062013

MEDILUX LABORATORIES PVT LTDTORSEMIDE

DMF 357362021

MICRO LABS LTDTORSEMIDE USP

DMF 359012021

KALINTIS HEALTHCARE PRIVATE LTDTORSEMIDE USP

DMF 366642022

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTORSEMIDE

DMF 152222001

APOTEX PHARMACHEM INDIA PVT LTDInactiveTORSEMIDE USP

DMF 184662005

CIPLA LTDInactiveTORSEMIDE USP

DMF 219542008

MICRO LABS LTD INDIAInactiveTORSEMIDE USP

DMF 246872010

JARI PHARMACEUTICAL CO LTDInactiveTORSEMIDE

DMF 262082012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 15, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jun 14, 2021

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10154963	Oct 6, 2033	—	—	Yes	—	—

#002 — 60MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 2021

#003 — 40MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 17, 2021