NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ULTRAM ER (tramadol hydrochloride) by Bausch + Lomb is mechanism of action ultram er is a centrally acting synthetic opioid analgesic. First approved in 2005.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ULTRAM ER is an extended-release oral tablet containing tramadol hydrochloride, a centrally acting synthetic opioid analgesic approved in 2005. It works through dual mechanisms: binding to µ-opioid receptors (via parent compound and the more potent M1 metabolite) and weak inhibition of norepinephrine and serotonin reuptake. The product is indicated for moderate to moderately severe pain management in patients requiring around-the-clock analgesia.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30% intensity), commercial teams should anticipate workforce restructuring and transition to generic defense strategies.
Mechanism of Action
Mechanism of Action ULTRAM ER is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.