NDAORALTABLETPriority Review
Approved
May 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORINASE (tolbutamide) is an oral first-generation sulfonylurea approved in 1957 for Type 2 Diabetes Mellitus. It works by stimulating pancreatic beta cells to increase insulin secretion, lowering blood glucose in patients with inadequate endogenous insulin production. This foundational diabetes agent has been a cornerstone of diabetes management for over six decades.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely small and focused on maintaining existing market share rather than growth initiatives.
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.
Clinical Trials (1)
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide
Started Nov 2021
12 enrolled
Healthy Volunteers
Career Relevance
Working on ORINASE offers limited career growth opportunity; roles are maintenance-focused on managing decline and optimizing profitability in a saturated, generic-dominated market. This assignment is best suited for early-career professionals seeking foundational commercial experience or those interested in lifecycle management and cost-optimization strategy.
Brand Manager (legacy/maintenance)
Worked on ORINASE at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.