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TIAMATE

NDA

DILTIAZEM MALATE | N020506 | MERCK AND CO INC

3 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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022)NCT07232589	Phase 1	Completed	Merck Sharp & Dohme LLC	26	2025-12-08 → 2026-06-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TANABE SEIYAKU CO LTDInactiveDILTIAZEM MALATE

DMF 110771994

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

Products (3)

Sort:

#001 — EQ 120MG HYDROCHLORIDE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 4, 1996

No patent or exclusivity listings for this strength.

#002 — EQ 180MG HYDROCHLORIDE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 4, 1996

#003 — EQ 240MG HYDROCHLORIDE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 4, 1996