Viewing data from:

CARDURA XL

NDA

DOXAZOSIN MESYLATE | N021269 | VIATRIS SPECIALTY LLC

2 strengths0 unique patents0 unique exclusivities

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 Cardura XL (2023)

Total Spending

$804K

Total Claims

2,010

Beneficiaries

674

Avg Cost/Unit

$6.68

Spending Trend

$674K(2019)→$780K(2020)→$820K(2021)→$703K(2022)→$804K(2023)

YoY Change:+9.2%

5yr CAGR:+6.1%

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

API Supply Chain6 active DMFs8 inactive

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

EXCELLA GMBH AND CO KGDOXAZOSIN MESYLATE

DMF 126341997

DR REDDYS LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 127501997

APOTEX PHARMACHEM INDIA PVT LTDDOXAZOSIN MESYLATE USP

DMF 130391998

APITORIA PHARMA PRIVATE LTDDOXAZOSIN MESYLATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 199592006

COHANCE LIFESCIENCES LTDDOXAZOSIN MESYLATE USP

DMF 229412009

UNICHEM LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 323752018

CIPLA LTDInactiveDOXAZOSIN MESYLATE

DMF 127841997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveDOXAZOSIN MESYLATE

DMF 138071998

CILAG AGInactiveDOXAZOSIN MESYLATE

DMF 141731999

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveDOXAZOSIN MESYLATE

DMF 142811999

MEDICHEM SAInactiveDOXAZOSIN MESYLATE

DMF 143661999

WOCKHARDT LTDInactiveDOXAZOSIN MESYLATE

DMF 152402001

CHONGQING BIOCARE PHARMACEUTICAL CO LTDInactiveDOXAZOSIN MESYLATE USP

DMF 206642007

STANDARD CHEM AND PHARM CO LTDInactiveDOXAZOSIN MESYLATE

DMF 207702007

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2021	SUPPL -21	View Letter (PDF)
Mar 3, 2017	SUPPL -18	View Letter (PDF)
Jun 10, 2015	SUPPL -17	View Letter (PDF)
Jul 12, 2011	SUPPL -12	View Letter (PDF)
Mar 22, 2010	SUPPL -11	View Letter (PDF)
Apr 5, 2006	SUPPL -1	View Letter (PDF)
Feb 23, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 4MG BASE

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 22, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 8MG BASE

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 22, 2005