Viewing data from:

FOCALIN

NDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | N021278 | SANDOZ 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7183 Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Dexmethylphenidate Hydrochloride Tablets 7.5 mg suitable for submission in an ANDA, with the reference listed drug being FOCALIN	Suitability	2026-06-29	Open	Senores Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Focalin (2023)

Total Spending

$93K

Total Claims

829

Beneficiaries

183

Avg Cost/Unit

$1.34

Spending Trend

$64K(2019)→$81K(2020)→$79K(2021)→$82K(2022)→$93K(2023)

YoY Change:+5.2%

5yr CAGR:+3.2%

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

API Supply Chain6 active DMFs

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

SIEGFRIED USA LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 132281998

LONZA INCDEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)

DMF 171172004

CURIA MISSOURI INCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 203852007

PURISYS LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 294112016

SPECGX LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 306572016

ALKEM LABORATORIES LTDDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 329022018

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Oct 16, 2023	SUPPL -31	View Letter (PDF)
Oct 16, 2023	SUPPL -28	View Letter (PDF)
Jun 29, 2021	SUPPL -29	View Letter (PDF)
Nov 20, 2019	SUPPL -26	View Letter (PDF)
Jan 18, 2019	SUPPL -11	View Letter (PDF)
Jan 18, 2019	SUPPL -19	View Letter (PDF)
Jan 10, 2017	SUPPL -23	View Letter (PDF)
Apr 20, 2015	SUPPL -18	View Letter (PDF)
Dec 13, 2013	SUPPL -17	View Letter (PDF)
Jun 12, 2013	SUPPL -16	View Letter (PDF)
May 4, 2012	SUPPL -15	View Letter (PDF)
Dec 15, 2010	SUPPL -13	View Letter (PDF)
Nov 22, 2010	SUPPL -12	View Letter (PDF)
May 1, 2007	SUPPL -8	View Letter (PDF)
Mar 15, 2007	SUPPL -7	View Letter (PDF)
Sep 18, 2006	SUPPL -5	View Letter (PDF)
Sep 18, 2006	SUPPL -4	View Letter (PDF)
Nov 13, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 13, 2001

No patent or exclusivity listings for this strength.

#002 — 5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 13, 2001

#003 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 13, 2001