FDA Orange Book · active-ingredient family
Tapentadol hydrochloride
Tapentadol hydrochloride: 3 brands, 3 generics; first approved Nov 20, 2008; generic available.
Generic available8 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
3
Listed patents
4
Next patent expiry
Apr 21, 2028
in 1 yr 8 mo
Brand (NDA) products
Originator applications
- NUCYNTARLDCOLLEGIUM PHARM INCNDA 2037942012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML SOLUTION ORAL Discontinued — - NUCYNTA ERRLDCOLLEGIUM PHARM INCNDA 20053320115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 100MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 150MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 200MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 250MG BASE TABLET, EXTENDED RELEASE ORAL Rx — - NUCYNTARLDCOLLEGIUM PHARM INCNDA 02230420083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- TAPENTADOL HYDROCHLORIDEHIKMAANDA 20505720263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Discontinued — EQ 75MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - TAPENTADOL HYDROCHLORIDEEPIC PHARMA LLCANDA 21437820263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - TAPENTADOL HYDROCHLORIDENOVITIUM PHARMAANDA 2191192026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML SOLUTION ORAL Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPPNew patient population exclusivity (3 years)
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 4 mo
- NPPNew patient population exclusivity (3 years)
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 4 mo
- NPPNew patient population exclusivity (3 years)
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 4 mo
- NPPNew patient population exclusivity (3 years)
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
in 4 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11344512 | in 1 yr 8 mo | U-3391 | |
| 8536130 | in 2 yr 1 mo | U-1276 | |
| 11344512*PED | in 2 yr 2 mo | ||
| 8536130*PED | in 2 yr 7 mo |
Approval history
FDA approval span
First approval
18 yr ago
Most recent approval
7 mo ago
Approvals span 2008–2026 across 6 FDA applications.
Brand (NDA) 350%
Generic (ANDA) 350%
Tapentadol hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
