tapentadol hydrochloride · Collegium Pharm Inc · NDA 022304, 203794
Nucynta
Earliest generic entry, as listed · earliest of 3 marketed strengths
3 Jan 2027
Blocked by exclusivity: PED.
FDA has approved 4 generic applications (ANDAs) for Nucynta, though its earliest generic-entry date is 3 Jan 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 3 Jan 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 205057, Hikma · 022304-001Approved 10 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220865, Msn · 022304-001Approved 3 Sep 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 219119, Novitium Pharma · 203794-001Approved 26 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219119, Novitium Pharma · 203794-001Approved 26 Jan 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 214378, Epic Pharma Llc · 022304-001Approved 27 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214378, Epic Pharma Llc · 022304-001Approved 27 Jan 2026Detected 25 Oct 2026Historical import
- Exclusivity expires within 90 days PED · 022304-003Exclusivity expires 3 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 022304-003Listed date 3 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 022304-002Exclusivity expires 3 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 022304-002Listed date 3 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 022304-001Exclusivity expires 3 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 022304-001Listed date 3 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 203794-001Exclusivity expires 3 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 203794-001Listed date 3 Jan 2027Detected 24 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022304 · 001 · RLD | tablet, oral | EQ 50MG BASE | 3 Jan 2027 |
| 022304 · 002 · RLD | tablet, oral | EQ 75MG BASE | 3 Jan 2027 |
| 022304 · 003 · RLD | tablet, oral | EQ 100MG BASE | 3 Jan 2027 |
| 203794 · 001 · RLD · discontinued | solution, oral | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 3 Jan 2027 |
Expired or delisted (1)
- NPP · 3 Jul 2026