BIPHETAMINE 12.5
LOE ApproachingNDAORALCAPSULE, EXTENDED RELEASE
Approved
Sep 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIPHETAMINE 12.5 is an oral extended-release capsule containing amphetamine salts, approved in 1955 for CNS stimulation. The mechanism of action involves dopamine and norepinephrine reuptake inhibition. This is a legacy small-molecule product with established clinical use.
LOE Approaching
As loss of exclusivity approaches, the brand team is likely being consolidated or transitioned, with reduced headcount and focus shifting to generic or follow-on products.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on BIPHETAMINE 12.5 offers limited growth potential and exposure to mature-product management and LOE strategy. Career value lies in learning defensive marketing, managed decline execution, and portfolio optimization in a generic-threatened environment.
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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.