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ISMO

NDA

ISOSORBIDE MONONITRATE | N019091 | PROMIUS PHARMA LLC

1 strength0 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 Isosorbide Mononitrate ER (2023)

Total Spending

$89.0M

Total Claims

4,673,338

Beneficiaries

1,121,415

Avg Cost/Unit

$0.28

Spending Trend

$98.2M(2019)→$94.8M(2020)→$88.1M(2021)→$85.7M(2022)→$89.0M(2023)

YoY Change:+4.9%

5yr CAGR:-2.3%

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

API Supply Chain0 active DMFs1 inactive

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

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)

DMF 208162007

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

Products (1)

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 1991

No patent or exclusivity listings for this strength.