NDAORALCAPSULE, EXTENDED RELEASE
Approved
Mar 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
INNOPRAN XL (propranolol hydrochloride) by ANI Pharmaceuticals is established. First approved in 2003.
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INNOPRAN XL is an extended-release oral formulation of propranolol hydrochloride, a non-selective beta-blocker approved in 2003 for hypertension management. It reduces blood pressure through decreased cardiac output, inhibition of renin release, and diminished sympathetic nerve outflow. The drug is indicated for patients requiring once-daily antihypertensive therapy.
$0.003BPart D
LOE ApproachingDeclining
Product is in late-stage commercialization with modest spending ($3M Part D annually) and faces significant generic competitive pressure; commercial teams should expect resource reallocation and LOE transition planning.
Mechanism of Action
established. Among factors that contribute to the antihypertensive action are: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer
Started Nov 2024
6 enrolled
Non Small Cell Lung CancerPropranolol
Fasting Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mg
Started Sep 2005
100 enrolled
Healthy
Food Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mg
Started Sep 2005
98 enrolled
Healthy
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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.