Manages acute pain severe enough to require an opioid analgesic. Sold as Nucynta, Nucynta Er. Every FDA application for this active ingredient: 3 branded and 6 generic.
As of Nov 15, 2026, FDA lists 9 applications for Tapentadol Hydrochloride (sold as Nucynta, Nucynta Er), first approved Nov 20, 2008, with 6 new uses approved and 0 published complete response letters.
| Nucynta | Part D | $59.7M | +6% | 7,843 |
| Nucynta ER | Part D | $48.9M | +2% | 4,622 |
| Tapentadol ER | Part D | $0K | New | 0 |
| Tapentadol HCl | Part D | $0K | New | 0 |
| Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric SurgeryPain Management, Overweight , Obesity · The First Hospital of Jilin University | Phase 3 | Recruiting | Sep 28, 2026 |
| Tapentadol vs Tramadol in Arthroscopic Rotator Cuff RepairArthroscopic Rotator Cuff Repair (ARCR), Postoperative Pain · University of Thessaly | — | Active, not recruiting | Aug 21, 2026 |
| OpioidRedoxStudyIIOxidative Stress, Opioid Use · EPC Education s.r.o. | — | Not yet recruiting | Jan 13, 2026 |
| ACU_Knee: Role of Acupuncture in Knee Prosthetic SurgeryAcupuncture Analgesia, Acupuncture · Fondazione IRCCS Policlinico San Matteo di Pavia | Not applicable | Recruiting | Aug 14, 2025 |
| Nov 20, 2008 | NucyntaNDA 22304 · New molecular entity | Collegium Pharm Inc | 22 | Marketed |
| Aug 25, 2011 | Nucynta ErNDA 200533 · New dosage form | Collegium Pharm Inc | 20 | Marketed |
| Oct 15, 2012 | NucyntaNDA 203794 · New dosage form | Collegium Pharm Inc | 14 | Discontinued |
| Jan 26, 2026 | Tapentadol HydrochlorideANDA 219119 | Novitium Pharma | 1 | Marketed |
| Jan 27, 2026 | Tapentadol HydrochlorideANDA 214378 | Epic Pharma LLC | 1 | Marketed |
| Feb 10, 2026 | Tapentadol HydrochlorideANDA 205057 | Hikma | 1 | Discontinued |
| Sep 3, 2026 | Tapentadol HydrochlorideANDA 220865 | Msn | 0 | Marketed |
| — | Tapentadol HydrochlorideANDA 206657 | Actavis Labs Ut Inc | 0 | Discontinued |
| — | Tapentadol HydrochlorideANDA 209369 | Rhodes Pharms | 0 | Discontinued |
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
Novitium Pharma
Hikma