Viewing data from:

XELSTRYM

NDA

DEXTROAMPHETAMINE | N215401 | NOVEN PHARMACEUTICALS INC

4 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

9456993

Oct. 24, 2033

9474722

Oct. 24, 2033

11559501

Jan. 6, 2042

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Xelstrym (2023)

Total Spending

$51K

Total Claims

103

Beneficiaries

Avg Cost/Unit

$16.56

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

API Supply Chain13 active DMFs1 inactive

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

VERANOVA LPDEXTROAMPHETAMINE SACCHARATE

DMF 150902000

CAMBREX CHARLES CITY INCDEXTROAMPHETAMINE SACCHARATE

DMF 153052001

SPECGX LLCDEXTROAMPHETAMINE SACCHARATE

DMF 154282001

CURIA NEW YORK INCDEXTROAMPHETAMINE SACCHARATE

DMF 160222002

SPECGX LLCDEXTROAMPHETAMINE BASE

DMF 165672003

CURIA NEW YORK INCDEXTROAMPHETAMINE DRUG INTERMEDIATE

DMF 195172006

VERANOVA LPDEXTROAMPHETAMINE SACCHARATE (PROCESS 2)

DMF 240712010

SIEGFRIED USA LLCDEXTROAMPHETAMINE SACCHARATE

DMF 296032016

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE BASE

DMF 326092018

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE SACCHARATE

DMF 380272025

SIEGFRIED USA LLCDEXTROAMPHETAMINE SACCHARATE

DMF 385432023

SPECGX LLCDEXTROAMPHETAMINE SACCHARATE NP

DMF 413472025

SPECGX LLCDEXTROAMPHETAMINE SULFATE USP NP

DMF 413482025

ISP FREETOWN FINE CHEMICALS INCInactiveDEXTROAMPHETAMINE SACCHARATE

DMF 156082001

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -15	View Letter (PDF)
Dec 2, 2024	SUPPL -11	View Letter (PDF)
Aug 17, 2022	SUPPL -1	View Letter (PDF)
Mar 23, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 4.5MG/9HR

RLD

3 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9456993	Oct 24, 2033	—	—	Yes		—
9474722	Oct 24, 2033	—	—	Yes	—	—
11559501	Jan 6, 2042	—	—	Yes	—	—

#002 — 9MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

#003 — 13.5MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022

#004 — 18MG/9HR

RLD

3 patents0 exclusivities▾

SYSTEM;TRANSDERMAL | Approved: Mar 22, 2022