Tapentadol
As of the edition of 20 October 2026, Tapentadol is a small molecule: marketed, first approved in 2008 (US); acts on OPRM1 and SLC6A2; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Nucynta
- First approved
- 20 November 2008 (US)
- Approvals on record
- 11 in 3 regions
- Holder of the most recent approval
- Johnson & Johnson; 3 holders in all
- Registered trials
- 64, 9 stopped early
- Disease areas
- Bones, joints and muscles; Nervous system; Cancer; Hormones; Lungs and airways; Chemically induced
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Collegium Pharmaceutical.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product8 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Tapentadol.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 4 | 1 | 0 |
| Phase 1 | 10 | 9 | 0 | 1 |
| Phase 2 | 10 | 9 | 0 | 1 |
| Phase 3 | 33 | 27 | 0 | 6 |
| Phase 4 | 6 | 5 | 0 | 1 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant, Later holder and Lead sponsor of trials | 2004 to now |
| Collegium Pharmaceutical | Acquired holder | 2020 to now |