NDAORALTABLET
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
BIDIL (hydralazine hydrochloride and isosorbide dinitrate) by R-Pharm US is established. Approved for heart failure, to prolong time to hospitalization for heart failure, to improve patient-reported functional status and 1 more indications. First approved in 2005.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIDIL is an oral combination tablet of hydralazine hydrochloride and isosorbide dinitrate, a nitrate vasodilator approved for heart failure. It works by dilating both arteries and veins through nitric oxide release, with hydralazine potentially mitigating nitrate tolerance. The drug is indicated to prolong time to hospitalization for heart failure and improve patient-reported functional status.
$2MPart D
LOE ApproachingDeclining
With LOE approaching and only $2M in Part D spending, BIDIL brand teams face significant headcount and budget reductions as the product exits market exclusivity.
Mechanism of Action
established. Isosorbide dinitrate is a vasodilator affecting both arteries and veins. Its dilator properties result from the release of nitric oxide and the subsequent activation of guanylyl cyclase, and ultimate relaxation of vascular smooth muscle. Several well-controlled clinical trials have…
Pharmacologic Class:
Nitrate Vasodilator
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.