Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Manages severe and persistent pain. Sold as Buprenex, Subutex, Probuphine, Belbuca. Every FDA application for this active ingredient: 4 branded and 16 generic.
As of Nov 15, 2026, FDA lists 20 applications for Buprenorphine Hydrochloride (sold as Buprenex, Subutex, Probuphine and others), first approved Dec 29, 1981, with 0 new uses approved and 0 published complete response letters.
First approved: Dec 29, 1981
Applications: 20
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $176M
First approved in the EU: Nov 20, 2018
First approved in Japan: Feb 23, 2011
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 350 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Norspan, new ingredientDrugs with a new active ingredient indicated for analgesia of chronic pain associated with osteoarthritis and lumbago which cannot be managed by treatments… · Mundipharma K.K. · Feb 23, 2011
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Probuphine REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled · Medication Guide for patients
Dec 11, 2024
Clinical Trials
128 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Hikma