Viewing data from:

XTAMPZA ER

NDA

OXYCODONE | N208090 | COLLEGIUM PHARMACEUTICAL INC

5 strengths8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Oct. 9, 2028

Dec. 10, 2030

Sep. 2, 2036

Sep. 2, 2036

Dec. 10, 2030

Sep. 2, 2036

Sep. 2, 2036

Dec. 10, 2030

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. 1:2018cv00300 12 patentsANDA 209431oxycodone	D. Del.	2018-02-22	Terminated 2020-10-07	—
Purdue Pharma L.P. et al v. Collegium Pharmaceutical, Inc. 1:2015cv13783 1 patentoxycodone hydrochloride	D. Mass.	2015-11-06	Active	—

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 Xtampza ER (2023)

Total Spending

$250.0M

Total Claims

371,710

Beneficiaries

52,082

Avg Cost/Unit

$11.75

Spending Trend

$124.4M(2019)→$161.3M(2020)→$240.9M(2021)→$259.8M(2022)→$250.0M(2023)

YoY Change:+4.8%

5yr CAGR:+8.2%

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

API Supply Chain4 active DMFs4 inactive

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

SPECGX LLCOXYCODONE BASE - CODE 8180

DMF 198982006

CHATTEM CHEMICALS INCOXYCODONE HYDROCHLORIDE, USP

DMF 234192010

VERANOVA LPOXYCODONE HCL

DMF 325062018

VERANOVA LPOXYCODONE BASE

DMF 340282019

MALLINCKRODT INCInactiveOXYCODONE TEREPHTHALATE

DMF 27961976

MALLINCKRODT CHEMICAL INCInactiveOXYCODONE TEREPHTHALATE-D

DMF 69771987

PENICK CORPInactiveOXYCODONE TEREPHTHALATE

DMF 94411991

NORAMCO INCInactiveOXYCODONE BASE DRUG SUBSTANCE

DMF 167322003

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -25	View Letter (PDF)
Dec 29, 2025	SUPPL -24	View Letter (PDF)
Nov 4, 2024	SUPPL -23	View Letter (PDF)
Dec 19, 2023	SUPPL -21	View Letter (PDF)
Mar 5, 2021	SUPPL -15	View Letter (PDF)
Oct 8, 2019	SUPPL -12	View Letter (PDF)
Oct 30, 2018	SUPPL -9	View Letter (PDF)
Oct 1, 2018	SUPPL -8	View Letter (PDF)
Oct 1, 2018	SUPPL -10	View Letter (PDF)
Nov 9, 2017	SUPPL -4	View Letter (PDF)
May 31, 2017	SUPPL -6	View Letter (PDF)
Dec 21, 2016	SUPPL -3	View Letter (PDF)
Oct 3, 2016	SUPPL -2	View Letter (PDF)
Apr 27, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 9MG

RLD

8 patents0 exclusivities▴