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NUCYNTA ER

NDA

TAPENTADOL HYDROCHLORIDE | N200533 | COLLEGIUM PHARMACEUTICAL INC

5 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayPED (+6 mo)

2027

2028

2029

Today

8536130

Mar. 22, 2029

11344512

Oct. 21, 2028

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

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Grunenthal GmbH v. MSN Laboratories Private Limited, et al. 1:2025cv01343 2 patentsANDA 220864tapentadol hydrochloride	D. Del.	2025-11-03	Active	—
ASSERTIO THERAPEUTICS, INC. et al v. ACTAVIS ELIZABETH LLC 2:2015cv06797 1 patentANDA 204972tapentadol hydrochloride	D.N.J.	2015-09-11	Terminated 2017-04-11	—
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 ER (2023)

Total Spending

$53.2M

Total Claims

45,262

Beneficiaries

6,559

Avg Cost/Unit

$20.74

Spending Trend

$12.9M(2019)→$65.3M(2020)→$63.7M(2021)→$66.8M(2022)→$53.2M(2023)

YoY Change:+10.0%

5yr CAGR:+15.5%

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

21 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -32	View Letter (PDF)
Dec 23, 2025	SUPPL -31	View Letter (PDF)
Nov 4, 2024	SUPPL -28	View Letter (PDF)
Nov 4, 2024	SUPPL -28	View Letter (PDF)
Jun 18, 2024	SUPPL -29	View Letter (PDF)
Dec 19, 2023	SUPPL -27	View Letter (PDF)
Mar 8, 2021	SUPPL -23	View Letter (PDF)
Oct 8, 2019	SUPPL -20	View Letter (PDF)
Oct 1, 2018	SUPPL -19	View Letter (PDF)
Oct 1, 2018	SUPPL -18	View Letter (PDF)
May 31, 2017	SUPPL -16	View Letter (PDF)
Dec 21, 2016	SUPPL -14	View Letter (PDF)
Oct 3, 2016	SUPPL -15	View Letter (PDF)
Apr 22, 2016	SUPPL -13	View Letter (PDF)
Jul 7, 2015	SUPPL -12	View Letter (PDF)
Aug 20, 2014	SUPPL -11	View Letter (PDF)
Apr 17, 2014	SUPPL -10	View Letter (PDF)
Apr 18, 2013	SUPPL -4	View Letter (PDF)
Aug 29, 2012	SUPPL -1	View Letter (PDF)
Jul 11, 2012	SUPPL -2	View Letter (PDF)
Aug 29, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

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#001 — EQ 50MG BASE

RLD

2 patents0 exclusivities▴