Treats hypertension. Sold as Catapres-Tts-1, Catapres-Tts-2, Catapres-Tts-3, Clonidine, Nexiclon Xr. Every FDA application for this active ingredient: 3 branded and 4 generic.
As of Nov 13, 2026, FDA lists 7 applications for Clonidine (sold as Catapres-Tts-1, Catapres-Tts-2, Catapres-Tts-3 and others), first approved Oct 10, 1984, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Clonidine | Part D | $56.0M | -8% | 105,805 |
| Clonidine HCl | Part D | $22.3M | -1% | 907,402 |
| Clonidine HCl ER | Part D | $1.9M | +40% | 4,645 |
| Onyda XR | Part D | $95K | New | 41 |
| Javadin | Part D | $0K | New | 0 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 10, 1984 | Catapres-Tts-1, Catapres-Tts-2NDA 18891 · New dosage form | Lavipharm | 28 | Marketed |
| Aug 18, 2009 | ClonidineANDA 76157 | Adaptis | 2 | Discontinued |
| Dec 3, 2009 | ClonidineNDA 22499 · New dosage form | Tris Pharma Inc | 1 | Discontinued |
| Dec 3, 2009 | Nexiclon XrNDA 22500 · New dosage form | Rosemont | 1 | Marketed |
| Jul 16, 2010 | ClonidineANDA 76166 | Mylan Technologies | 3 | Marketed |
| Aug 20, 2010 | ClonidineANDA 79090 | Dr Reddys Labs SA | 1 | Marketed |
| May 6, 2014 | ClonidineANDA 90873 | Actavis Labs Ut Inc | 1 | 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
