Sold as Vivactil. Every FDA application for this active ingredient: 1 branded and 5 generic.
As of Nov 14, 2026, FDA lists 6 applications for Protriptyline Hydrochloride (sold as Vivactil), first approved Sep 27, 1967, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Protriptyline HCl | Part D | $1.5M | -20% | 1,045 |
| Sep 27, 1967 | VivactilNDA 16012 · New molecular entity | Teva Womens | 28 | Discontinued |
| Aug 24, 1995 | VivactilANDA 73644 | Chartwell Rx | 9 | Discontinued |
| Aug 24, 1995 | VivactilANDA 73645 | Chartwell Rx | 12 | Discontinued |
| Sep 16, 2008 | Protriptyline HydrochlorideANDA 78913 | Hikma | 1 | Discontinued |
| May 3, 2010 | Protriptyline HydrochlorideANDA 90462 | Sigmapharm Labs LLC | 1 | Marketed |
| Nov 19, 2012 | Protriptyline HydrochlorideANDA 202220 | Epic Pharma LLC | 3 | Marketed |
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