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 · 5 docket documents 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, based on the reference listed drug FOCALIN Ta	Suitability	2026-06-29	Open	Senores Pharmaceuticals, Inc.

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

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions NCT00829712	Phase 1	Completed	Teva Pharmaceuticals USA	24	2004-06 → 2004-06
CTx-1301 Comparative Bioavailability Study NCT04138498	Phase 1/2	Completed	Cingulate Therapeutics	45	2019-12-06 → 2020-03-06
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder NCT00301236	Phase 3	Completed	Novartis	252	2006-02 → 2006-11
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions NCT00829673	Phase 1	Completed	Teva Pharmaceuticals USA	24	2004-06 → 2004-06
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits NCT01399827	Phase 2	Completed	Massachusetts General Hospital	2	2012-02 → 2017-11
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR NCT00393042	Phase 3	Completed	Seattle Children's Hospital	77	2006-01 → 2009-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$1.33

per ea

Lowest NADAC/Unit

$0.6499

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758025201FOCALIN 10 MG TABLET	$1.33	EA	Brand	$0.3391	2026-06-17
00078038105FOCALIN 5 MG TABLET	$0.9206	EA	Brand	$0.2718	2026-06-17
66758025101FOCALIN 5 MG TABLET	$0.9206	EA	Brand	$0.2718	2026-06-17
66758025001FOCALIN 2.5 MG TABLET	$0.6499	EA	Brand	$0.1895	2026-05-20

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$49.65

Highest Price

$103.61

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0381-05FOCALIN 5MG TAB	$71.91	FSS	Sandoz, Inc.	08/14/2028
66758-0250-01FOCALIN 2.5MG TAB	$49.65	FSS	Sandoz, Inc.	08/14/2028
66758-0252-01FOCALIN 10MG TAB	$103.61	FSS	Sandoz, Inc.	08/14/2028
66758-0251-01FOCALIN 5MG TAB	$71.91	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Focalin (2024)

Total Spending

$102K

Total Claims

995

Beneficiaries

225

Avg Cost/Unit

$1.24

Spending Trend

$64K(2019)→$81K(2020)→$79K(2021)→$82K(2022)→$93K(2023)→$102K(2024)

YoY Change:-7.5%

5yr CAGR:+0.9%

Source: CMS Medicare Part D Spending by Drug (2024). 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