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TIAZAC

NDA

DILTIAZEM HYDROCHLORIDE | N020401 | BAUSCH HEALTH US LLC

6 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Tiazac (2023)

Total Spending

$108K

Total Claims

541

Beneficiaries

114

Avg Cost/Unit

$3.15

Spending Trend

$246K(2019)→$199K(2020)→$165K(2021)→$125K(2022)→$108K(2023)

YoY Change:+0.1%

5yr CAGR:+2.1%

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

API Supply Chain7 active DMFs11 inactive

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

LUSOCHIMICA SPADILTIAZEM HYDROCHLORIDE

DMF 66861986

TAPI NL BVDILTIAZEM HYDROCHLORIDE USP

DMF 72391987

FIS FABBRICA ITALIANA SINTETICI SPADILTIAZEM HYDROCHLORIDE

DMF 76001988

PIRAMAL PHARMA LTDDILTIAZEM HYDROCHLORIDE USP

DMF 147132000

DIVIS LABORATORIES LTDDILTIAZEM HYDROCHLORIDE USP

DMF 152672001

CHEMECA DRUGS PRIVATE LTDDILTIAZEM HYDROCHLORIDE USP

DMF 342202020

VASUDHA PHARMA CHEM LTDDILTIAZEM HYDROCHLORIDE USP

DMF 407222024

TORCAN CHEMICAL LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 72401987

PCASInactiveDILTIAZEM HYDROCHLORIDE

DMF 77561988

FABBRICA ITALIANA SINTETICI SPAInactiveDILTIAZEM HYDROCHLORIDE

DMF 79081989

HAMARI CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 85481990

ICHIKAWA LAB CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87061990

TATEISHI SEIYAKU CO LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 87991990

MITSUBISHI TANABE PHARMA CORPInactiveDILTIAZEM HYDROCHLORIDE (PROCESS C)

DMF 103811993

SUMITRA PHARMACEUTICALS AND CHEMICALS LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 104661993

DR REDDYS LABORATORIES LTDInactiveDILTIAZEM HYDROCHLORIDE

DMF 115041995

SYN-TECH CHEM AND PHARM CO LTDInactiveDILTIAZEM HYDROCHLORIDE USP

DMF 146592000

FARMAK ASInactiveDILTIAZEM HYDROCHLORIDE

DMF 154182001

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2025	SUPPL -44	View Letter (PDF)
Nov 22, 2016	SUPPL -42	View Letter (PDF)
Nov 30, 2010	SUPPL -36	View Letter (PDF)
Jul 5, 2007	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 120MG

RLDAB4

0 patents0 exclusivities▴