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NUCYNTA

NDA

TAPENTADOL HYDROCHLORIDE | N022304 | COLLEGIUM PHARMACEUTICAL INC

3 strengths0 unique patents2 unique exclusivities

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayPED (+6 mo)Exclusivity

2027

Today

NPP

Jan. 3, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Janssen Pharmaceuticals, Inc. et al v. Roxane Laboratories, Inc. 3:2013cv00639 1 patentANDA 205057tapentadol hydrochloride	NVD	2013-11-15	Terminated 2014-03-12	—
Allkem Laboratories Limited v. NPS Pharmaceuticals, Inc 1:2013cv06487 1 patentANDA 205015, 205016tapentadol	N.D. Ill.	2013-09-10	Terminated 2013-11-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nucynta (2023)

Total Spending

$58.8M

Total Claims

58,074

Beneficiaries

10,048

Avg Cost/Unit

$11.92

Spending Trend

$15.9M(2019)→$50.7M(2020)→$53.8M(2021)→$57.0M(2022)→$58.8M(2023)

YoY Change:+9.8%

5yr CAGR:+11.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

NORAMCO LLCTAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE

DMF 210842008

CURIA MISSOURI INCTAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE

DMF 264902012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 265192012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 314352017

MSN ORGANICS PRIVATE LTDTAPENTADOL HYDROCHLORIDE

DMF 413162025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -30	View Letter (PDF)
Dec 31, 2025	SUPPL -29	View Letter (PDF)
Nov 4, 2024	SUPPL -27	View Letter (PDF)
Jun 18, 2024	SUPPL -28	View Letter (PDF)
Dec 19, 2023	SUPPL -26	View Letter (PDF)
Jul 5, 2023	SUPPL -24	View Letter (PDF)
Mar 5, 2021	SUPPL -23	View Letter (PDF)
Oct 8, 2019	SUPPL -22	View Letter (PDF)
Oct 1, 2018	SUPPL -21	View Letter (PDF)
Oct 1, 2018	SUPPL -19	View Letter (PDF)
Dec 21, 2016	SUPPL -16	View Letter (PDF)
Nov 6, 2013	SUPPL -15	View Letter (PDF)
Nov 6, 2013	SUPPL -14	View Letter (PDF)
Jul 12, 2013	SUPPL -12	View Letter (PDF)
Jul 12, 2013	SUPPL -8	View Letter (PDF)
Jul 12, 2013	SUPPL -7	View Letter (PDF)
Jul 12, 2013	SUPPL -9	View Letter (PDF)
Jul 12, 2013	SUPPL -11	View Letter (PDF)
Nov 4, 2010	SUPPL -3	View Letter (PDF)
Nov 4, 2010	SUPPL -4	View Letter (PDF)
Jan 20, 2010	SUPPL -1	View Letter (PDF)
Jan 25, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

RLDAB

0 patents2 exclusivities▴

TABLET;ORAL | Approved: Nov 20, 2008

Exclusivities (2)

Code	Date	Status
NPP	Jul 3, 2026	Expired
PED	Jan 3, 2027	< 1 year

#002 — EQ 75MG BASE

RLDAB

0 patents2 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2008

#003 — EQ 100MG BASE

RLDAB

0 patents2 exclusivities▾

TABLET;ORAL | Approved: Nov 20, 2008