TAPENTADOL Drug Patent Profile
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Which patents cover Tapentadol, and when can generic versions of Tapentadol launch?
Tapentadol is a drug marketed by Novitium Pharma, Hikma, and Humanwell. and is included in three NDAs.
The generic ingredient in TAPENTADOL is tapentadol hydrochloride. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tapentadol
A generic version of TAPENTADOL was approved as tapentadol hydrochloride by NOVITIUM PHARMA on January 26th, 2026.
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Questions you can ask:
- What is the 5 year forecast for TAPENTADOL?
- What are the global sales for TAPENTADOL?
- What is Average Wholesale Price for TAPENTADOL?
Summary for TAPENTADOL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| What excipients (inactive ingredients) are in TAPENTADOL? | TAPENTADOL excipients list |
| DailyMed Link: | TAPENTADOL at DailyMed |
US Patents and Regulatory Information for TAPENTADOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novitium Pharma | TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | SOLUTION;ORAL | 219119-001 | Jan 26, 2026 | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Humanwell | TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | TABLET;ORAL | 214378-003 | Jan 27, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | TABLET;ORAL | 205057-003 | Feb 10, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | TABLET;ORAL | 205057-001 | Feb 10, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
