Viewing data from:

DEXEDRINE SPANSULE

NDA

DEXTROAMPHETAMINE SULFATE | N017078 | IMPAX LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

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 Dextroamphetamine Sulfate ER (2023)

Total Spending

$6.7M

Total Claims

38,266

Beneficiaries

6,750

Avg Cost/Unit

$2.38

Spending Trend

$9.1M(2019)→$470K(2019)→$9.1M(2020)→$562K(2020)→$8.7M(2021)→$526K(2021)→$287K(2022)→$7.5M(2022)→$6.7M(2023)→$382K(2023)

YoY Change:-3.0%

5yr CAGR:-3.1%

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

API Supply Chain7 active DMFs1 inactive

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

VERANOVA LPDEXTROAMPHETAMINE SULFATE

DMF 147832000

CAMBREX CHARLES CITY INCDEXTROAMPHETAMINE SULFATE USP

DMF 153072001

SPECGX LLCDEXTROAMPHETAMINE SULFATE USP

DMF 153852001

CURIA NEW YORK INCDEXTROAMPHETAMINE SULFATE USP

DMF 160212002

VERANOVA LPDEXTROAMPHETAMINE SULFATE USP

DMF 235832010

SIEGFRIED USA LLCDEXTROAMPHETAMINE SULFATE

DMF 296042016

CHATTEM CHEMICALS INCDEXTROAMPHETAMINE SULFATE USP

DMF 312442017

ISP FREETOWN FINE CHEMICALS INCInactiveDEXTROAMPHETAMINE SULFATE

DMF 156072001

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Sep 24, 2025	SUPPL -59	View Letter (PDF)
Oct 16, 2023	SUPPL -55	View Letter (PDF)
Feb 28, 2022	SUPPL -54	View Letter (PDF)
Jan 22, 2019	SUPPL -52	View Letter (PDF)
May 24, 2017	SUPPL -50	View Letter (PDF)
Jan 10, 2017	SUPPL -49	View Letter (PDF)
Apr 20, 2015	SUPPL -48	View Letter (PDF)
Dec 10, 2013	SUPPL -47	View Letter (PDF)
Jun 13, 2013	SUPPL -46	View Letter (PDF)
May 28, 2008	SUPPL -44	View Letter (PDF)
May 7, 2007	SUPPL -42	View Letter (PDF)
Aug 14, 2006	SUPPL -40	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 15MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982